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COVID answers in Scientific Journals all over the world


358 Results       Page 1

 [1] 
Springer (Biomed Central Ltd.): Trials
  original article Date Title Authors   Max. 6 Authors
1 [GO] 2024―Mar―07 IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS) Hannah Preßler, Marie-Luise Machule, Friederike Ufer, Isabel Bünger, Lucie Yuanting Li, Emilie Buchholz, Claudia Werner, Esther Beraha, Frank Wagner, Matthes Metz, Susen Burock, Lisa Bruckert, Christiana Franke, Nicola Wilck, Anne Krüger, Alexander Reshetnik, Kai-Uwe Eckardt, Matthias Endres, Harald Prüss
2 [GO] 2024―Feb―08 Correction: Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza, Ellen Kerns
3 [GO] 2024―Jan―22 Efficacy and safety of azvudine in symptomatic adult COVID-19 participants who are at increased risk of progressing to critical illness: a study protocol for a multicentre randomized double-blind placebo-controlled phase III trial Xinlun Tian, Yan Xu, Luo Wang, Chongya Dong, Xiaoyan Yan, Junping Fan, Huaiya Xie, Hong Zhang, Jinglan Wang, Yongjian Liu, Yaqi Wang, Siqi Pan, Aohua Wu, Xueqi Liu, Chen Yao, Mengzhao Wang
4 [GO] 2024―Jan―11 Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV) Sarah Baos, Rachel Todd, Russell Thirard, Rosie Harris, Jana Kirwan, Katherine Joyce, David Hutton, Adam Finn, Madeleine Clout, Heike Cappel-Porter, Chris A Rogers, Rajeka Lazarus, Lucy Culliford
5 [GO] 2023―Dec―05 Characterization of COVID-19 vaccine clinical trial discussions on the social question-and-answer site Quora Qing Xu, Tiana J. McMann, Jiawei Li, Christine Wenzel, Tim K. Mackey
6 [GO] 2023―Nov―11 Beneficial effects of the combination of BCc1 and Hep-S nanochelating-based medicines on IL-6 in hospitalized moderate COVID-19 adult patients: a randomized, double-blind, placebo-controlled clinical trial Maryam Hafizi, Somayeh Kalanaky, Saideh Fakharzadeh, Pegah Karimi, Atefeh Fakharian, Somayeh Lookzadeh, Esmaeil Mortaz, Maryam Sadat Mirenayat, Jalal Heshmatnia, Mehrdad Bakhshayesh Karam, Homa Zamani, Alireza Nadji, Mihan Pourabdollah Toutkaboni, Saeed Oraee-Yazdani, Mohammad Esmaeil Akbari, Hamidreza Jamaati, Mohammad Hassan Nazaran
7 [GO] 2023―Oct―04 Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities Nomathemba Chandiwana, Chelsea Kruger, Naomi Richardson, Sibongiseni Nxumalo, Nkoleleng Mashilo, Yengiwe Dineka, Ntanganedzeni Mudau, Hilary Johnstone, Wookyung Kim, Chung Ju, Sarah Arbe-Barnes, Anne Claire Marrast, Julia Flynn, Willem D. Francois Venter
8 [GO] 2023―Oct―04 Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses Andrew R. DiNardo, Moshe Arditi, Ashish M. Kamat, Kent J. Koster, Santiago Carrero, Tomoki Nishiguchi, Maxim Lebedev, Aaron B. Benjamin, Pablo Avalos, Marisa Lozano, Madeleine G. Moule, Brittany McCune, Baysia Herron, Malik Ladki, Daanish Sheikh, Matthew Spears, Ivan A. Herrejon, Courtney Dodge, Sathish Kumar, Robert W. Hutchison, Theresa U. Ofili, Lynne A. Opperman, Jessica A. Bernard, Seth P. Lerner, George Udeani, Gabriel Neal, Mihai G. Netea, Jeffrey D. Cirillo
9 [GO] 2023―Sep―19 Correction: Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs, Christopher Butler
10 [GO] 2023―Sep―16 A double-blind, randomised, placebo-controlled parallel study to investigate the effect of sex and dietary nitrate on COVID-19 vaccine-induced vascular dysfunction in healthy men and women: protocol of the DiNOVasc-COVID-19 study Asad Shabbir, Ismita Chhetri, Rayomand S. Khambata, Tipparat Parakaw, Clement Lau, Muhammad A. B. N. Aubdool, Gianmichele Massimo, Nicki Dyson, Vikas Kapil, Thomas Godec, Vanessa Apea, Jan Flint, Chloe Orkin, Krishnaraj S. Rathod, Amrita Ahluwalia
11 [GO] 2023―Aug―30 Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial Brittany B. Dennis, Lehana Thabane, Diane Heels-Ansdell, Joanna C. Dionne, Alexandra Binnie, Jennifer Tsang, Gordon Guyatt, Aijaz Ahmed, François Lauzier, Adam Deane, Yaseen Arabi, John Marshall, Nicole Zytaruk, Lois Saunders, Simon Finfer, John Myburgh, John Muscedere, Shane English, Marlies Ostermann, Miranda Hardie, Serena Knowles, Deborah Cook
12 [GO] 2023―Aug―07 Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals Daniel Kang, Cher X. Huang, Alexander D. Yuen, Keith C. Norris, Tara Vijayan
13 [GO] 2023―Jul―12 Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol Prabha H. Andraweera, Bing Wang, Margie Danchin, Christopher Blyth, Ivo Vlaev, Jason Ong, Jodie Dodd, Jennifer Couper, Thomas R. Sullivan, Jonathan Karnon, Nicola Spurrier, Michael Cusack, Dylan Mordaunt, Dimi Simatos, Gus Dekker, Samantha Carlson, Jane Tuckerman, Nicholas Wood, Lisa Whop, Helen S. Marshall
14 [GO] 2023―Jul―05 The effects of functional foods mixture on inflammatory cytokines and biochemical findings in hospitalized patients with COVID-19: a randomized double-blind controlled trial Hadi Esmaeili Gouvarchinghaleh, Fateme Kiany, Karim Parastouei, Gholamhosein Alishiri, Nematollah Jonaidi Jafari, Abbas Ali Imani Fooladi, Afsaneh Pargar, Ali Ghazvini, Reza Mirnejad, Mehdi Raei, Ahmadreza Sharifi Olounabadi, Mansour Babaei, Soleyman Heydari, Hosein Rostami, Alireza Shahriary, Gholamreza Farnoosh, Vahid Sobhani, Mohammad Mahdi Mazhari, Farshad NajjarAsiabani
15 [GO] 2023―Jun―22 Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions Ava Lorenc, Leila Rooshenas, Carmel Conefrey, Julia Wade, Nicola Farrar, Nicola Mills, Sangeetha Paramasivan, Alba Realpe, Marcus Jepson
16 [GO] 2023―May―22 Correction: Favipiravir and/or nitazoxanide: a randomized, double-blind, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE) Tania A. Smith, Carlos Hoyo-Vadillo, Akosua Agyeman Adom, Liliana Favari-Perozzi, Silke Gastine, Hakim-Moulay Dehbi, Beatriz Villegas-Lara, Eduardo Mateos, Yessica Sara Pérez González, Maria D. Navarro-Gualito, Alejandra S. Cruz-Carbajal, Miguel A. Cortes-Vazquez, Carolina Bekker-Méndez, Charmina Aguirre-Alvarado, Gisela Aguirre-Gil, Lucero Delgado-Pastelin, Andrew Owen, David Lowe, Joseph Standing, Jorge Escobedo
17 [GO] 2023―May―13 Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trial Mushidur Rahman, Sophie L. Russell, Nduka C. Okwose, Olivia M. A. Hood, Amy E. Harwood, Gordon McGregor, Stuart M. Raleigh, Hardip Sandhu, Laura C. Roden, Helen Maddock, Prithwish Banerjee, Djordje G. Jakovljevic
18 [GO] 2023―May―11 The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team’s experience Linda L. Chlan, Mary Fran Tracy, Jessica Ask, Amos Lal, Jay Mandrekar
19 [GO] 2023―Apr―13 Impact of the COVID-19 pandemic on a clinical trial of pneumococcal vaccine scheduling (PVS) in rural Gambia Ilias Hossain, Isaac Osei, Galega Lobga, Baleng M. Wutor, Yekini Olatunji, Williams Adefila, Banjo Adeshola, Yasir Isa, Cattram Nguyen, Kemo Sonko, Lamin Ceesay, B뫊rr Baldeh, Omar Barrow, Benjamin Young, Saidina Ceesay, Abdoullah Nyassi, Golam Sarwar, Ousman Barjo, Momodou M.Drammeh, Rasheed Salaudeen, Grant Mackenzie
20 [GO] 2023―Apr―04 Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries Kelsey McDonald, Earl Seltzer, Mary Lu, Stefan Diaz Gaisenband, Cassandra Fletcher, Patrick McLeroth, Kamal S Saini
21 [GO] 2023―Apr―01 Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth Michael Anastario, Elizabeth Rink, Paula Firemoon, Nicole Carnegie, Olivia Johnson, Malory Peterson, Ana Maria Rodriguez
22 [GO] 2023―Mar―26 Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO) C. McLeod, J Ramsay, K. L. Flanagan, M. Plebanski, H. Marshall, M. Dymock, J. Marsh, M. J. Estcourt, U. Wadia, P. C. M. Williams, M. C. Tjiam, C. Blyth, K. Subbarao, S. Nicholson, S. Faust, R. B. Thornton, A. Mckenzie, T. L Snelling, P. Richmond
23 [GO] 2023―Mar―26 PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V) Toby J. L. Humphrey, Davinder Dosanjh, Thomas F. Hiemstra, Alex Richter, Michael Chen-Xu, Wendi Qian, Vivekanand Jha, Katrina Gatley, Rakshya Adhikari, Francis Dowling, Rona M. Smith
24 [GO] 2023―Mar―17 Correction: Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project Vanessa Bertuzzi, Michelle Semonella, Gerhard Andersson, Gian Mauro Manzoni, Gianluca Castelnuovo, Enrico Molinari, Giada Pietrabissa
25 [GO] 2023―Feb―20 Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial Hela Abroug, Amani Maatouk, Cyrine Bennasrallah, Wafa Dhouib, Manel Ben Fredj, Imen Zemni, Meriem Kacem, Salma Mhalla, Sarra Nouira, Manel Ben Belgacem, Aymen Nasri, Rim Klii, Chawki Loussaief, Nissaf Ben Alya, Ines Bouanene, Asma Belguith Sriha
26 [GO] 2023―Feb―07 Correction: The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium Enya Daynes, Molly Baldwin, Neil J. Greening, Thomas Yates, Nicolette C. Bishop, George Mills, Matthew Roberts, Malik Hamrouni, Tatiana Plekhanova, Ioannis Vogiatzis, Carlos Echevarria, Rashmita Nathu, Hamish J. C. McAuley, Lorna Latimer, Jennifer Glennie, Francesca Chambers, Ruth Penfold, Emily Hume, Dimitrios Megaritis, Charikleia Alexiou, Sebastian Potthof, Mitchell James Hogg, Catherine Haighton, Bethany Nichol, Olivia C. Leavy, Matthew Richardson, Omer Elneima, Amisha Singapuri, Marco Sereno, Ruth M. Saunders, Victoria C. Harris, Claire M. Nolan, Charlotte Bolton, Linzy Houchen-Wolloff, Ewen M. Harrison, Nazir Lone, Jennifer Quint, James D. Chalmers, Ling-Pei Ho, Alex Horsley, Michael Marks, Krisnah Poinasamy, Betty Ramen, Louise V. Wain, Christopher Brightling, William D.-C. Man, Rachael Evans, Sally J. Singh
27 [GO] 2023―Feb―06 The effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial Nahid Ramezani-Jolfaie, Ebrahim Eftekhar, Mohadese Dadinasab, Zahra Ghaeini Hesarooeyeh, Pooria Pakdaman, Farkhondeh Razmpour, Gholamali Javedan, Mahmood Khayatian, Mehdi Hassani Azad, Parivash Davoodian, Elham Brahimi, Shideh Rafati, Sara Nikoofal-Sahlabadi, Mohammad Mohammadi
28 [GO] 2023―Jan―26 The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium Enya Daynes, Molly Baldwin, Neil J. Greening, Thomas Yates, Nicolette C. Bishop, George Mills, Matthew Roberts, Malik Hamrouni, Tatiana Plekhanova, Ioannis Vogiatzis, Carlos Echevarria, Rashmita Nathu, Hamish J. C. McAuley, Lorna Latimer, Jennifer Glennie, Francesca Chambers, Ruth Penfold, Emily Hume, Dimitrios Magaritis, Charikleia Alexiou, Sebastian Potthoff, Mitchell James Hogg, Catherine Haighton, Bethany Nichol, Olivia C. Leavy, Matthew Richardson, Omer Elneima, Amisha Singapuri, Marco Sereno, Ruth M. Saunders, Victoria C. Harris, Claire M. Nolan, Charlotte Bolton, Linzy Houchen-Wolloff, Ewen M. Harrison, Nazir Lone, Jennifer Quint, James D. Chalmers, Ling-Pei Ho, Alex Horsley, Michael Marks, Krisnah Poinasamy, Betty Ramen, Louise V. Wain, Christopher Brightling, William D.-C. Man, Rachael Evans, Sally J. Singh
29 [GO] 2023―Jan―19 Effects of physical training on functional, clinical, morphological, behavioural and psychosocial outcomes in post-COVID-19 infection: COVID-19 and REhabilitation study (CORE-study)-a study protocol for a randomised controlled clinical trial Rodrigo Sudatti Delevatti, Angelica Danielevicz, Maria Eduarda Sirydakis, Paulo Urubatan Gama de Melo, Cíntia de la Rocha Freitas, Cassiano Ricardo Rech, Luiz Guilherme Antonacci Guglielmo, Guilherme Fleury Fina Speretta, Fernanda Hansen, Fernanda Rodrigues Fonseca, Ana Carolina Starke, Ricardo Dantas de Lucas, José Tavares de Melo Junior, Rosemeri Maurici, Aline Mendes Gerage
30 [GO] 2023―Jan―14 Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies Rana Charide, Lisa Stallwood, Matthew Munan, Shahab Sayfi, Lisa Hartling, Nancy J. Butcher, Martin Offringa, Sarah Elliott, Dawn P. Richards, Joseph L. Mathew, Elie A. Akl, Tamara Kredo, Lawrence Mbuagbaw, Ashley Motillal, Ami Baba, Matthew Prebeg, Jacqueline Relihan, Shannon D. Scott, Jozef Suvada, Maicon Falavigna, Miloslav Klugar, Tamara Lotfi, Adrienne Stevens, Kevin Pottie, Holger J. Schünemann
31 [GO] 2022―Dec―20 Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the WORKWELL trial due to the impact of the COVID-19 pandemic Angela Ching, Jennifer Parker, Alexandra Haig, Chris J. Sutton, Sarah Cotterill, Denise Forshaw, June Culley, Alison Hammond
32 [GO] 2022―Dec―20 The comparison between the effects of pain education interventions with online and face-to-face exercise and the control group received biomedical education + standardized physical therapy in patients with chronic nonspecific neck pain during COVID-19: protocol for a parallel-group randomized controlled trial Zohre Khosrokiani, Amir Letafatkar, Malihe Hadadnezhad, Yahya Sokhanguei
33 [GO] 2022―Dec―14 ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial Justin T. Denholm, Balasubramanian Venkatesh, Joshua Davis, Asha C. Bowen, Naomi E. Hammond, Vivekanand Jha, Grace McPhee, Zoe McQuilten, Matthew V. N. O’Sullivan, David Paterson, David Price, Megan Rees, Jason Roberts, Mark Jones, James Totterdell, Thomas Snelling, Nanette Trask, Susan Morpeth, Steven YC Tong
34 [GO] 2022―Dec―05 The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial Julia Velonjara, Brianna Mills, Silvia Lujan, Gustavo Petroni, Michael J. Bell, Nahuel Guadagnoli, Charles Mock, James P. Hughes, Monica S. Vavilala, Ali Rowhani-Rahbar, Mariela Alassia, Silvina Abalos, Natalia Gómez Arriola, Pablo Castellani, Sandra Chuchuy, Karina Cinquegrani, Carlos Dávila, Adriana Diettes, Gabriela López Cruz, Alejandro Mansur, Ivana Marinelli, Paula Medici, Silvia Oliveri, Matías Penazzi, Graciela Romero, Ariel Segado, Alejandra Depetris, Daniel Giordano, Linda Ng Boyle, Megan Moore, Bryan Weiner, Karen Segar, Jin Wang, Shyam J. Deshpande, Chelsea Hicks, Janessa Graves
35 [GO] 2022―Nov―16 A randomised controlled trial to compare clinical and cost-effectiveness of an online parent-led treatment for child anxiety problems with usual care in the context of COVID-19 delivered in Child and Adolescent Mental Health Services in the UK (Co-CAT): a study protocol for a randomised controlled trial Lucy Taylor, Sophie Giles, Sophie Howitt, Zoe Ryan, Emma Brooks, Lucy Radley, Abigail Thomson, Emily Whitaker, Fauzia Knight, Claire Hill, Mara Violato, Polly Waite, Vanessa Raymont, Ly-Mee Yu, Victoria Harris, Nicola Williams, Cathy Creswell
36 [GO] 2022―Nov―08 Phase II/III trial of hyperimmune anti-COVID-19 intravenous immunoglobulin (C-IVIG) therapy in severe COVID-19 patients: study protocol for a randomized controlled trial Shaukat Ali, Elisha Shalim, Farah Farhan, Fatima Anjum, Ayesha Ali, Syed Muneeb Uddin, Faisal Shahab, Mustafa Haider, Iqra Ahmed, Mir Rashid Ali, Sadaf Khan, Sadia Rao, Kabeer Guriro, Saud Elahi, Muhammad Ali, Tehreem Mushtaq, Muneeba Ahsan Sayeed, Sheikh Muhammad Muhaymin, Shoba Luxmi, Saeed Qureshi
37 [GO] 2022―Nov―08 Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies Jie Deng, John N. Lukens, Joy C. Cohn, Erin McMenamin, Barbara Murphy, Bryan A. Spinelli, Niya Murphy, Alicia K. Steinmetz, Megan A. Landriau, Alexander Lin
38 [GO] 2022―Nov―04 Self-management strategies and multicomponent training to mitigate the effects of the interruption of physical exercise programmes in the pandemic context on functionality, sedentary behaviour, physical capacity, mental health, body composition and quality of life in older adults: a blinded randomized controlled study protocol Ana Claudia Silva Farche, Gabriela Cassemiliano, Paulo Giusti Rossi, Bianca Ferdin Carnavale, Stefany Lee, Laura Bonome Message, Vinícius Ramon da Silva Santos, Juliana Hotta Ansai, Eduardo Ferriolli, Natália Duarte Pereira, Guillermo Rúben Oviedo, Myriam Guerra-Balic, Maria Giné-Garriga, Marina Araújo Lopes, Anielle Cristhine de Medeiros Takahashi
39 [GO] 2022―Oct―28 Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza, Ellen Kerns
40 [GO] 2022―Oct―22 Brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression during the COVID-19 pandemic: a randomised controlled trial protocol Caio Borba Casella, Pedro Fonseca Zuccolo, Luisa Sugaya, Aline Santana de Souza, Luara Otoch, Fernanda Alarcão, Wagner Gurgel, Daniel Fatori, Guilherme V. Polanczyk
41 [GO] 2022―Oct―21 WILL (When to Induce Labour to Limit risk in pregnancy hypertension): a multicentre randomised controlled trial - adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic Laura A. Magee, Sue Tohill, Katie Kirkham, Ruth Evans, Eleni Gkini, Catherine A. Moakes, Clive Stubbs, Jim Thornton, Peter von Dadelszen, Peter Brocklehurst, Lucy Chappell, Jon Dorling, Marcus Green, Pollyanna Hardy, Jennifer Hutcheon, Katie Kirkham, Catherine Moakes, Ben Mol, Katie Morris, Paul Riley, Tracy Roberts, Janet Scott, Joel Singer, Ruth Unstead-Joss, Julie Wade, Ben W. Mol, Tim Draycott, Graeme MacLennan, Lucy MacKillop, Paul Mannix, Diana Elbourne, Henk Groen, Edile Murdoch, Sarah Stock, Sumita Bhuiya, Soumendra Nallapeta, Emma Dooks, Sophie Packham, Diane Whitehouse, Chloe O’Hara, Connie Weston, Diane Mellers, Lesley Brittain, Phern Adams, Rebecca Shakespeare, Sudeepthi Kakara, Janet Wright, Amal Mighell, Jennifer Syson, Kari Swettenham, Jenny Eedle, Shaila Seraj, Maryanne Bray, Bethan Jones, Claire Bertorelli, Hannah Ritter, Vikki Keeping, Janet Cresswell, Mary Kelly-Baxter, Li-Shan Yeoh, Shailly Sahu Bhansali, Vandana More, Bini Ajay, Geraldine Upson, Danielle Hake, Diana Opoku, Emma Wayman, Natalia Cwiek, Stacy Tregellas, Nikki Lee, Lavinia Margarit, Joelle Pike, Kate Jones, Sophie-Mae Wheeler-Davies, Meena Ali, Indhuja Rajkumar, Ruth Habibi, Sarah Davies, Anangsha Kumar, Harinakshi Salian, Trudy Smith, Deepika Meneni, Hazel Alexander, Helen Harwood, Kerry Hebbron, Lynn Whitecross, Mary Hodgers, Shilpa Mahadasu, Nick Kametas, Yasmin Sana, Hayley Martin, Rebecca Jarman, Sophie Webster, Jyothi Rajeswary, Mandy Gill, Gabrielle Bambridge, Isabel Bradley, Kristina Sexton, Lola Oshodi, Cornelia Wiesender, Claire Dodd, Rupa Modi, Beverley Cowlishaw, Gina Mulheron, Magdalena Kierzenkowska, Molly Patterson, Patricia Amos, Sharon Marie Bates, Sharon Raper, Umber Agarwal, Ruth Cockerill, Amy Mahdi, Caroline Cunningham, Michelle Dower, Sian Andrews, Siobhan Holt, Carly Williams, Zora Castling, Linda Watkins, David Churchill, Ellmina McKenzie, Julie Icke, Laura Devison, Vinita Raheja, Angela Ayuk, Jessica Reynolds, Julie Wyton, Stacey Duffy, Kate Walker, Jane Cantliffe, Catriona Hussain, Carys Smith, Harriet Anderson, Lesley Hodgen, Karen Brackley, Nicki Martin, Fiona Walbridge, Rhea Hampton, Nia Jones, Patrick Bose, Catherine Young, Fidelma Lee, Rebecca Peart, Emma Tanton, Kat Rhead, Kristin Fiedler, Ruth Bowen, Stephy Mathen, Zainab Sarwar, Chloe Rishton, Chloe Scott, Jane Farey, Nisha Verasingam, Mel Rich, Annette Moreton, Catherine Bressington, Jennifer Pullen, Sara Burnard, Wendy Duberry, Madhuchanda Dey, Sharon Jones, Pauline Bird, Aarti Ullal, Eileen Walton, Ashleigh Price, Janet Scollen, Judith Ormonde, Kirsten Herdman, Lesley Hewitt, Lucy Rowland, Mandeep Singh, Sundararajah Raajkumar, Beena Saji, Asma Khalil, Alice Perry, Emily Marler, Ijeoma Imuzeze, Sophie Robinson, Jonathan Nelson, Kathryn McNamara, Carina Craig, Del Endersby, Jayne Wagstaff, Kate Robinson, Hannah Barnes, Jane Gavin, Jenny Myers, Kate Stanbury, Christine Hughes, Latha Vinayakarao, Louise Melson, Stephanie Grigsby, Susara Blunden, Melanie Griffin, Sarah Newell, Katharine Jane Thompson, Brittany Smart, Elizabeth Payne, Marie Pitchford, Rahila Khan, Sophia Stone, Ahmed Elgarhy, Emma Meadows, Marian Flynn-Batham, Nikky Passmore, Vivienne Cannons, Declan Symington, Alice Lewin, Hayley Tarft, Jessamine Hunt, Zoe Vowles, Maria Slaney, Rachel Woodcock, Alex Van der Meer, Tracey Benn, Ru Davies, Sophie Boyd, Gareth Waring, Jill Riches, Andrea Fenn, Aly Kimber, Susan Harrop, Daniel Stott, Amos Tetteh, Davide Casagrandi, Miriam Bourke, Eirini Vaikousi, Rita Sarquis, Morenike Folorunsho, Olivia Newth, Sarah Weist, Yaa Acheampong, Vidhya Ravikumar, Jemma Yorke, Vicki Atkinson, Shelly Wood, Tigist Mengistu, Robert Chadwick, Helen Haden, Lisa Richardson, Joanna Girling, Amy Barker, Andrea Day, Elaine Palmer, Louise Page, Millicent Nwandison, Osaeloke Osakwe, Philippe de Rosnay, Sana Usman, Susan Barnes, Grace Ryan, Komal Lal, Lauren Trepte, Samantha Steele, Jacqueline Tang, Harriet Pearson, Jo Ingham, Nicola Spark
42 [GO] 2022―Oct―18 Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19 Peter A. G. Sandercock, Janet Darbyshire, David DeMets, Robert Fowler, David G. Lalloo, Mohammed Munavvar, Natalie Staplin, Adilia Warris, Janet Wittes, Jonathan R. Emberson
43 [GO] 2022―Oct―14 Kangyi Qiangshen Gong exercise prescription for pulmonary function and quality of life in patients recovered from COVID-19: a study protocol for a randomized controlled trial Guangxin Guo, Xiruo Xu, Wong Yu Yin, Kunyu Zhang, Jacelyn Pang Min Hui, Janice Hiew Yuen Yee, Bryan Chung Qi Heng, Yuan Qin, Fei Yao, Min Fang
44 [GO] 2022―Oct―08 A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network Julia M. Neuhann, Jannik Stemler, Antonio Carcas, Jesús Frías-Iniesta, Ullrich Bethe, Sarah Heringer, Lea Tischmann, Marouan Zarrouk, Arnd Cüppers, Franz König, Martin Posch, Oliver A. Cornely
45 [GO] 2022―Oct―06 A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials Arnela Suman, Jasmijn van Es, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan A. Heath, Isla S. Mackenzie, Ghislaine van Thiel, Mira G. P. Zuidgeest
46 [GO] 2022―Sep―30 The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research Lada Leyens, Tracy Simkins, Nafsika Kronidou Horst
47 [GO] 2022―Sep―29 Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department Dalia Abdulhussein, Timothy E. Yap, Haider Manzar, Serge Miodragovic, Francesca Cordeiro
48 [GO] 2022―Sep―24 Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project Vanessa Bertuzzi, Michelle Semonella, Gerhard Andersson, Gian Mauro Manzoni, Gianluca Castelnuovo, Enrico Molinari, Giada Pietrabissa
49 [GO] 2022―Sep―21 Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China Chen-Chi Duan, Jia-Le Yu, Jing Tao, Chen Zhang, Dan Zhang, Xiu Zeng, Wan-Ting Zeng, Hua-Lin Xu, Jian-Yin Qiu, Cindy-Lee Dennis, Li Jin, He-Feng Huang, Yan-Ting Wu
50 [GO] 2022―Sep―20 Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial Maria Boesing, Kristin Abig, Michael Brändle, Martin Brutsche, Emanuel Burri, Björn C. Frye, Stéphanie Giezendanner, Jan C. Grutters, Philippe Haas, Justian Heisler, Fabienne Jaun, Anne B. Leuppi-Taegtmeyer, Giorgia Lüthi-Corridori, Joachim Müller-Quernheim, Reto Nüesch, Wolfgang Pohl, Frank Rassouli, Jörg D. Leuppi
51 [GO] 2022―Sep―15 Effect of EARLY administration of DEXamethasone in patients with COVID-19 pneumonia without acute hypoxemic respiratory failure and risk of development of acute respiratory distress syndrome (EARLY-DEX COVID-19): study protocol for a randomized controlled trial Anabel Franco-Moreno, María Soledad Acedo-Gutiérrez, Nicolás Labrador-San Martín, Clara Hernández-Blanco, Celia Rodríguez-Olleros, Fátima Ibáñez-Estéllez, Ana Suárez-Simón, Mateo Balado-Rico, Ana Rocío Romero-Paternina, David Alonso-Menchén, Belén Escolano-Fernández, Esther Piniella-Ruiz, Ester Alonso-Monge, Helena Notario-Leo, Carlos Bibiano-Guillén, Gabriela Peña-Lillo, Armando Antiqueira-Pérez, Rodolfo Romero-Pareja, Noemí Cabello-Clotet, Vicente Estrada-Pérez, Jesús Troya-García, María de Carranza-López, Ismael Escobar-Rodríguez, Nacho Vallejo-Maroto, Juan Torres-Macho
52 [GO] 2022―Sep―15 A study protocol for a double-blind randomised placebo-controlled trial evaluating the efficacy of carrageenan nasal and throat spray for COVID-19 prophylaxis-ICE-COVID Z. M. Jessop, J. Gibson, J. Y. Lim, T. H. Jovic, E. Combellack, T. D. Dobbs, K. Carter, S. Hiles, S. Islam, B. Healy, I. Humphreys, R. Eccles, H. A. Hutchings, I. S. Whitaker
53 [GO] 2022―Sep―15 Rapamycin and inulin for booster vaccine response stimulation (RIVASTIM)-rapamycin: study protocol for a randomised, controlled trial of immunosuppression modification with rapamycin to improve SARS-CoV-2 vaccine response in kidney transplant recipients Matthew Tunbridge, Griffith B. Perkins, Julian Singer, Tania Salehi, Tracey Ying, Branka Grubor-Bauk, Simon Barry, Beatrice Sim, Pravin Hissaria, Steven J. Chadban, P. Toby Coates
54 [GO] 2022―Sep―14 The CHARTER-Ireland trial: can nebulised heparin reduce acute lung injury in patients with SARS-CoV-2 requiring advanced respiratory support in Ireland: a study protocol and statistical analysis plan for a randomised control trial John Robert Sheehan, Padraig Calpin, Maeve Kernan, Claire Kelly, Siobhan Casey, Darragh Murphy, Alberto Alvarez-Iglesias, Camilla Giacomini, Catriona Cody, Gerard Curley, Shane McGeary, Ciara Hanley, Bairbre McNicholas, Frank van Haren, John G. Laffey, David Cosgrave
55 [GO] 2022―Sep―02 Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study Sina M. Coldewey, Charles Neu, Frank Bloos, Philipp Baumbach, Ulrike Schumacher, Michael Bauer, Philipp Reuken, Andreas Stallmach
56 [GO] 2022―Sep―02 Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic Julie C. Reid, Alex Molloy, Geoff Strong, Laurel Kelly, Heather O’Grady, Deborah Cook, Patrick M. Archambault, Ian Ball, Sue Berney, Karen E. A. Burns, Frederick D’Aragon, Erick Duan, Shane W. English, François Lamontagne, Amy M. Pastva, Bram Rochwerg, Andrew J. E. Seely, Karim Serri, Jennifer L. Y. Tsang, Avelino C. Verceles, Brenda Reeve, Alison Fox-Robichaud, John Muscedere, Margaret Herridge, Lehana Thabane, Michelle E. Kho
57 [GO] 2022―Sep―02 Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial Luca Bodini, Chiara Bonetto, Simone Cheli, Lidia Del Piccolo, Michela Rimondini, Alberto Rossi, Angela Carta, Stefano Porru, Francesco Amaddeo, Antonio Lasalvia
58 [GO] 2022―Sep―02 Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms Simon Hatcher, Joel Werier, Nicole E. Edgar, James Booth, D. William J. Cameron, Vicente Corrales-Medina, Daniel Corsi, Juthaporn Cowan, Pierre Giguère, Mark Kaluzienski, Shawn Marshall, Tiago Mestre, Bryce Mulligan, Heather Orpana, Amanda Pontefract, Darlene Stafford, Kednapa Thavorn, Guy Trudel
59 [GO] 2022―Aug―26 Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial Anan Manomaipiboon, Kittisak Pholtawornkulchai, Sujaree Poopipatpab, Swangjit Suraamornkul, Jakravoot Maneerit, Wiroj Ruksakul, Uraporn Phumisantiphong, Thananda Trakarnvanich
60 [GO] 2022―Aug―20 Effectiveness and adherence to closed face shields in the prevention of COVID-19 transmission: a non-inferiority randomized controlled trial in a middle-income setting (COVPROSHIELD) Andrea Ramirez Varela, Alejandro Pacheco Gurruchaga, Silvia Restrepo Restrepo, Juan David Martin, Yessica Daniela Campaz Landazabal, Guillermo Tamayo-Cabeza, Sandra Contreras-Arrieta, Yuldor Caballero-Díaz, Luis Jorge Hernandez Florez, John Mario González, Juan Carlos Santos-Barbosa, José David Pinzón, Juan José Yepes-Nuñez, Rachid Laajaj, Giancarlo Buitrago Gutierrez, Martha Vives Florez, Janner Fuentes Castillo, Gianni Quinche Vargas, Andres Casas, Antonio Medina, Eduardo Behrentz, Yenny Paola Rueda Guevara, Daniela Rodriguez Sanchez, Marcela Guevara-Suarez, Marylin Hidalgo, Paola Betancourt
61 [GO] 2022―Aug―19 Notes from an epicenter: navigating behavioral clinical trials on autism spectrum disorder amid the COVID-19 pandemic in the Bronx Alaina S. Berruti, Roseann C. Schaaf, Emily A. Jones, Elizabeth Ridgway, Rachel L. Dumont, Benjamin Leiby, Catherine Sancimino, Misung Yi, Sophie Molholm
62 [GO] 2022―Aug―19 Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients - the randomized, EU-wide, placebo-controlled, phase II study design of IXION Jan Kloka, Benjamin Friedrichson, Stephanie Dauth, Ann Christina Foldenauer, Anita Bulczak-Schadendorf, Maria J. G. T. Vehreschild, Francisco Maio Matos, Antoni Riera-Mestre, Antoinette D. I. van Asselt, Edoardo De Robertis, Vilma Traskaite Juskeviciene, Patrick Meybohm, Dana Tomescu, Karine Lacombe, Coen D. A. Stehouwer, Kai Zacharowski, Oliver Old, Markus Ketomaeki, Lea Grebe, Patrick Booms, Simone Lindau, Sebastian Zinn, Isabel Maushagen, Timo Wolf, Christoph Stephan, Cathy Weynants, Sylvia Daamen, Petra Wülfroth, Thomas Steiner, Marinus van Hulst, Peter Kranke, Sebastian Hottenrott, Tobias Schlesinger, Benedikt Schmid, Daniel Röder, Eva Kranke, Tobias Haas, Philipp Schlesinger, Magdalena Sitter, Davide Valeri, Raquel Torres Iglesias, José María Mora-Luján, Adriana Iriarte, Pau Cerdà, Neringa Vaguliene, Andrius Macas, Jolanta Litviniene, Kristina Balne, Catarina Monteiro, Inês Antunes Ferreira, Patrícia Couceiro, Pedro Soares, Sofia Beirão, Yasmine Abi Aad, Thibault Chiarabini, Mihai Popescu, C. J. H. van der Kallen
63 [GO] 2022―Aug―17 Lessons from the COVID-19 pandemic and recent developments on the communication of clinical trials, publishing practices, and research integrity: in conversation with Dr. David Moher Daeria O. Lawson, Michael K. Wang, Kevin Kim, Rachel Eikelboom, Myanca Rodrigues, Daniela Trapsa, Lehana Thabane, David Moher
64 [GO] 2022―Aug―15 Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise-CISCO-21 A. Morrow, Stuart R. Gray, H. K. Bayes, R. Sykes, E. McGarry, D. Anderson, D. Boiskin, C. Burke, J. G. F. Cleland, C. Goodyear, T. Ibbotson, C. C. Lang, F. Mair, K. Mangion, M. Patel, N. Sattar, D. Taggart, R. Taylor, S. Dawkes, C. Berry
65 [GO] 2022―Aug―09 Resistance training and clinical status in patients with postdischarge symptoms after COVID-19: protocol for a randomized controlled crossover trial “The EXER-COVID Crossover Study” Robinson Ramírez-Vélez, Julio Oteiza, Juan Manuel Casas Fernández de Tejerina, Nora García-Alonso, Gaizka Legarra-Gorgoñon, Sergio Oscoz-Ochandorena, Hugo Arasanz, Yesenia García-Alonso, María Correa-Rodríguez, Mikel Izquierdo
66 [GO] 2022―Aug―08 Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial Moataz Maher Emara, Neamat Hamdy Elsawy, Kholoud M. Abdelaaty, Amal Salah Elhamaky, Naglaa Hamdi Eltahan
67 [GO] 2022―Aug―01 Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer’s Disease (NorAD): study protocol for a randomised clinical trial and COVID-19 amendments Karen Hoang, Hilary Watt, Mara Golemme, Richard J. Perry, Craig Ritchie, Danielle Wilson, James Pickett, Chris Fox, Robert Howard, Paresh A. Malhotra
68 [GO] 2022―Jul―22 Favipiravir and/or nitazoxanide: a randomized, double-blind, 2×2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE) Tania Smith, Carlos Hoyo-Vadillo, Akosua Agyeman Adom, Liliana Favari-Perozzi, Silke Gastine, Hakim-Moulay Dehbi, Beatriz Villegas-Lara, Eduardo Mateos, Yessica Sara Pérez González, Maria D. Navarro-Gualito, Alejandra S. Cruz-Carbajal, Miguel A. Cortes-Vazquez, Carolina Bekker-Méndez, Charmina Aguirre-Alvarado, Gisela Aguirre-Gil, Lucero Delgado-Pastelin, Andrew Owen, David Lowe, Joseph Standing, Jorge Escobedo
69 [GO] 2022―Jul―05 Correction: Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses Pepa Bruce, Kate Ainscough, Lee Hatter, Irene Braithwaite, Lindsay R. Berry, Mark Fitzgerald, Thomas Hills, Kathy Brickell, David Cosgrave, Alex Semprini, Susan Morpeth, Scott Berry, Peter Doran, Paul Young, Richard Beasley, Alistair Nichol
70 [GO] 2022―Jun―27 Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses Pepa Bruce, Kate Ainscough, Lee Hatter, Irene Braithwaite, Lindsay R. Berry, Mark Fitzgerald, Thomas Hills, Kathy Brickell, David Cosgrave, Alex Semprini, Susan Morpeth, Scott Berry, Peter Doran, Paul Young, Richard Beasley, Alistair Nichol
71 [GO] 2022―Jun―22 Drugs and convalescent plasma therapy for COVID-19: a survey of the interventional clinical studies in Italy after 1 year of pandemic Maria Puopolo, Cristina Morciano, Maria Buoncervello, Chiara De Nuccio, Rosa Luisa Potenza, Elena Toschi, Lucia Palmisano
72 [GO] 2022―Jun―18 Patient and health practitioner views and experiences of a cancer trial before and during COVID-19: qualitative study Frances C. Sherratt, Peter Fisher, Amy Mathieson, Mary G. Cherry, Andrew R. Pettitt, Bridget Young
73 [GO] 2022―Jun―16 Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC] Xuan Ying Poh, I. Russel Lee, Clarissa Lim, Jefanie Teo, Suma Rao, Po Ying Chia, Sean W. X. Ong, Tau Hong Lee, Ray J. H. Lin, Lisa F. P. Ng, Ee Chee Ren, Raymond T. P. Lin, Lin-Fa Wang, Laurent Renia, David Chien Lye, Barnaby E. Young
74 [GO] 2022―Jun―06 Clinical trial registration during COVID-19 and beyond in the African context: what have we learned? Lindi Mathebula, Sinazo Runeyi, Charles Wiysonge, Duduzile Ndwandwe
75 [GO] 2022―Jun―06 The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial Gholamreza Askari, Amirhossein Sahebkar, Davood Soleimani, Atena Mahdavi, Sahar Rafiee, Muhammed Majeed, Farzin Khorvash, Bijan Iraj, Mahshid Elyasi, Mohammad Hossein Rouhani, Mohammad Bagherniya
76 [GO] 2022―Jun―02 A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial Federica Pallavicini, Eleonora Orena, Simona di Santo, Luca Greci, Chiara Caragnano, Paolo Ranieri, Costanza Vuolato, Alessandro Pepe, Guido Veronese, Stefano Stefanini, Federica Achille, Antonios Dakanalis, Luca Bernardelli, Francesca Sforza, Angelo Rossini, Carlo Caltagirone, Sara Fascendini, Massimo Clerici, Giuseppe Riva, Fabrizia Mantovani
77 [GO] 2022―May―21 The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory Emily C. O’Brien, Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson, Patrick J. Heagerty, Adrian F. Hernandez, Lesley H. Curtis
78 [GO] 2022―May―12 E-Consent-a guide to maintain recruitment in clinical trials during the COVID-19 pandemic Ricardo Almeida-Magana, Hanna Maroof, Jack Grierson, Rosie Clow, Eoin Dinneen, Tarek Al-Hammouri, Nicola Muirhead, Chris Brew-Graves, John Kelly, Greg Shaw
79 [GO] 2022―Apr―27 Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial J. M. McGree, C. Hockham, S. Kotwal, A. Wilcox, A. Bassi, C. Pollock, L. M. Burrell, T. Snelling, V. Jha, M. Jardine, M. Jones
80 [GO] 2022―Apr―27 Conducting a randomised controlled trial of a psychosocial intervention for adolescents with type 1 diabetes during COVID-19: recommendations to overcome the challenges complicated by inconsistent public health guidelines on research Sinead Pembroke, Shauna Rogerson, Imelda Coyne
81 [GO] 2022―Apr―21 Correction to: SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion Sarah Halford, Susan Wan, Ilaria Dragoni, Julie Silvester, Bobojon Nazarov, Daniel Anthony, Suzie Anthony, Emma Ladds, John Norrie, Kevin Dhaliwal
82 [GO] 2022―Apr―21 PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial Robert M. Rodriguez, Kelli O’Laughlin, Stephanie A. Eucker, Anna Marie Chang, Kristin L. Rising, Graham Nichol, Alena Pauley, Hemal Kanzaria, Alexzandra T. Gentsch, Cindy Li, Herbie Duber, Jonathan Butler, Vidya Eswaran, Dave Glidden
83 [GO] 2022―Apr―14 Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community Liliane Windsor, Ellen Benoit, Rogério M. Pinto, Jesus Sarol
84 [GO] 2022―Apr―12 A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID) Pierre Malchair, Aurema Otero, Jordi Giol, Xavier Solanich, Thiago Carnaval, Alonso Fernández-Nistal, Ana Sánchez-Gabriel, Carmen Montoto, Ramon Lleonart, Sebastián Videla, Arnau Antoli, Marta Benjumeda, Tania Bernal, Laura Calatayud, Xavier Corbella, Anna Ferrer, Vanesa Garcia, Mercè Gasa, Carlota Gudiol, Pilar Hereu, Javier Jacob, Hector Jofre, Ferran Llopis, Leire Matellan, Natalia Pallarés, Raul Rigo, Gemma Rocamora, Freddy Rodríguez, Alexander Rombauts, José Carlos Ruibal, Joan Sabater, Carmen Serrano, Ana Suárez-Lledó, Cristian Tebé, Jesús Villoria, Alvaro Zarauza
85 [GO] 2022―Apr―08 Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial Alexander M. Kaizer, Jessica Wild, Christopher J. Lindsell, Todd W. Rice, Wesley H. Self, Samuel Brown, B. Taylor Thompson, Kimberly W. Hart, Clay Smith, Michael S. Pulia, Nathan I. Shapiro, Adit A. Ginde
86 [GO] 2022―Apr―04 Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate to severe ARDS in a randomized, placebo-controlled, double-blind trial: preliminary evaluation of safety and feasibility in light of the COVID-19 pandemic Benedikt Schmid, Peter Kranke, Rudolf Lucas, Patrick Meybohm, Bernhard Zwissler, Sandra Frank
87 [GO] 2022―Apr―04 The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial Marcelo Augusto Duarte Silveira, Sergio Pinto de Souza, Erica Batista dos Santos Galvão, Maurício Brito Teixeira, Marcel Miranda Dantas Gomes, Lucas Petri Damiani, Bruno Andrade Bahiense, Julia Barros Cabral, Cicero Wandson Luiz Macedo De Oliveira, Talita Rocha Mascarenhas, Priscila Carvalho Guedes Pinheiro, Milena Souza Alves, Rodrigo Morel Vieira de Melo, Andresa Aparecida Berretta, Flávia Mendes Leite, Carolina Kymie Vasques Nonaka, Bruno Solano de Freitas Souza, Ana Verena Almeida Mendes, Suzete Farias da Guarda, Rogério da Hora Passos
88 [GO] 2022―Mar―18 Effectiveness of an adapted diving mask (Owner mask) for non-invasive ventilation in the COVID-19 pandemic scenario: study protocol for a randomized clinical trial Dulciane Nunes Paiva, Litiele Evelin Wagner, Sônia Elvira dos Santos Marinho, Carlos Fernando Drumond Dornelles, Juliana Fernandes de Souza Barbosa, Patrícia Érika de Melo Marinho
89 [GO] 2022―Feb―19 Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants Simiao Chen, Sebastian Forster, Juntao Yang, Fengyun Yu, Lirui Jiao, Jennifer Gates, Zhuoran Wang, Haitao Liu, Qiushi Chen, Pascal Geldsetzer, Peixin Wu, Chen Wang, Shannon McMahon, Till Bärnighausen, Maya Adam
90 [GO] 2022―Feb―16 The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19 Leila Atmowihardjo, Job R. Schippers, Imke H. Bartelink, Pierre M. Bet, Nienke van Rein, Keith Purdy, David Cavalla, Valérie Comberiati, Andrew McElroy, Sue D. Snape, Harm Jan Bogaard, Leo Heunks, Nicole Juffermans, Marcus Schultz, Pieter R. Tuinman, Lieuwe D. J. Bos, Jurjan Aman
91 [GO] 2022―Feb―15 Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
92 [GO] 2022―Feb―14 Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients Graciela Cárdenas, María Chávez-Canales, Ana María Espinosa, Antonio Jordán-Ríos, Daniel Anica Malagon, Manlio Fabio Márquez Murillo, Laura Victoria Torres Araujo, Ricardo Leopoldo Barajas Campos, Rosa María Wong-Chew, Luis Esteban Ramirez González, Karent Ibet Cresencio, Enrique García Velázquez, Mariana Rodriguez de la Cerda, Yoana Leyva, Joselin Hernández-Ruiz, María Luisa Hernández-Medel, Mireya León-Hernández, Karen Medina Quero, Anahí Sánchez Monciváis, Sergio Hernández Díaz, Ignacia Rosalia Zeron Martínez, Adriana Martínez-Cuazitl, Iván Noé Martínez Salazar, Eduardo Beltrán Sarmiento, Aldo Figueroa Peña, Patricia Saraí Hernández, Rafel Ignacio Aguilar Reynoso, Daniela Murillo Reyes, Luis Rodrigo del Río Ambriz, Rogelio Antonio Alfaro Bonilla, Jocelyn Cruz, Leonor Huerta, Nora Alma Fierro, Marisela Hernández, Mayra Pérez-Tapia, Gabriela Meneses, Erick Espíndola-Arriaga, Gabriela Rosas, Alberto Chinney, Sergio Rosales Mendoza, Juan Alberto Hernández-Aceves, Jaquelynne Cervantes-Torres, Anai Fuentes Rodríguez, Roxana Olguin Alor, Sandra Ortega Francisco, Evelyn Alvarez Salazar, Hugo Besedovsky, Marta C. Romano, Raúl J. Bobes, Helgi Jung, Gloria Soldevila, Juan López-Alvarenga, Gladis Fragoso, Juan Pedro Laclette, Edda Sciutto
93 [GO] 2022―Feb―04 High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study-VitCov Trial Fabienne Jaun, Maria Boesing, Giorgia Lüthi-Corridori, Kristin Abig, Anja Makhdoomi, Nando Bloch, Christina Lins, Andrea Raess, Victoria Grillmayr, Philippe Haas, Philipp Schuetz, Luca Gabutti, Jürgen Muser, Anne B. Leuppi-Taegtmeyer, Stéphanie Giezendanner, Michael Brändle, Jörg D. Leuppi
94 [GO] 2022―Feb―02 Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial Yaseen Arabi, Sara Aldekhyl, Saad Al Qahtani, Hasan M. Al-Dorzi, Sheryl Ann Abdukahil, Jesna Jose, Mohammad Khulaif Al Harbi, Husain Al Haji, Mohammed Al Mutairi, Omar Al Zumai, Eman Al Qasim, Wedyan Al Wehaibi, Mohammed Alshahrani, Talal Albrahim, Ahmed Mady, Ali Al Bshabshe, Zohair Al Aseri, Zainab Al Duhailib, Ayman Kharaba, Rakan Alqahtani, Haifa Algethamy, Omar Alfaris, Omar Alnafel, Abdulrahman A. Al-Fares, Haytham Tlayjeh
95 [GO] 2022―Jan―31 Cluster randomised, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralising bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2-positive individuals: a study protocol Anneli Uusküla, Aime Keis, Karolin Toompere, Anu Planken, Konstantin Rebrov
96 [GO] 2022―Jan―20 Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs, Christopher Butler
97 [GO] 2022―Jan―19 Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Iqra Farooq, Rutaba Akmal, Muhammad Ahmad Imran, Larab Kalsoom, Sidra Ashraf, Sundas Rafique, Muhammad Ghufran, Muhammad Kiwan Akram, Muhammad Faisal Nadeem, Nazish Matti, Uzma Nasim Siddiqui, Ayesha Humayun, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar, Zaigham Habib, Kanwal Hayat, Ghazala Amjad, Misbah Kousar, Shahroze Arshad, Umair Hafeez, Tayyab Mughal, Muhammad Sikandar Saleem, Ammara Ahmad, Abeer bin Awais, Noman Khalid, Qurat-ul-Ain Iqbal, Muhammad Hassan, Abdul Rehman Virk, Mehak Gul, Muhammad Tayyab Naeem, Roa Umer, Musa Khalil, Tayyaba Muzafar, Sibgha Zulfiqar, Saadia Shahzad Alam, Emed Chohan, Muhammad Imran Anwar, Ali Rafique Mirza, Amber Malik, Talha Mahmud, Adeen Akmal, Syed Sami Husain Sherazi, Zartasha Safdar, Sohail Ahmad, Ali Arshad, Khawar Nawaz, Muhammad Ismail Khalid Yousaf, Muhammad Nauman Zahid
98 [GO] 2022―Jan―18 Mental imagery interventions to promote face covering use among UK university students and employees during the COVID-19 pandemic: study protocol for a randomized controlled trial. Dominic Conroy
99 [GO] 2022―Jan―15 Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)-study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl, Jozef Klučka, Roman Gál, Mervyn Singer
100 [GO] 2021―Dec―24 Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)-a review Sabrina Tulka, Christine Baulig, Stephanie Knippschild
101 [GO] 2021―Dec―11 Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic in self-reported good and poor sleepers (Sleep COVID-19): study protocol for a randomised controlled trial Olivia L. Sawdon, Greg J. Elder, Nayantara Santhi, Pamela Alfonso-Miller, Jason G. Ellis
102 [GO] 2021―Dec―11 A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond Jane A. H. Masoli, Kim Down, Gary Nestor, Sharon Hudson, John T. O’Brien, James D. Williamson, Carolyn A. Young, Camille Carroll
103 [GO] 2021―Dec―11 Feasibility of remote neurocognitive assessment: pandemic adaptations for a clinical trial, the Cognition and Obstructive Sleep Apnea in Parkinson’s Disease, Effect of Positive Airway Pressure Therapy (COPE-PAP) study Annie C. Lajoie, Joelle Crane, Ann R. Robinson, Anne-Louise Lafontaine, Andrea Benedetti, R. John Kimoff, Marta Kaminska
104 [GO] 2021―Dec―04 A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial A. Abayomi, A. Osibogun, O. Ezechi, K. Wright, B. Ola, O. Ojo, Y. Kuyinu, E. Zamba, H. Abdur-Razzaq, O. A. Erinoso, S. E. Anya
105 [GO] 2021―Dec―02 A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol T. A. Kuut, F. Müller, A. Aldenkamp, E. Assmann-Schuilwerve, A. Braamse, S. E. Geerlings, K. B. Gibney, R. A. A. Kanaan, P. Nieuwkerk, T. C. Olde Hartman, D. Pauëlsen, M. Prins, K. Slieker, M. Van Vugt, C. P. Bleeker-Rovers, S. P. Keijmel, H. Knoop
106 [GO] 2021―Nov―27 Auricular acupressure for adverse events following immunization related to COVID-19 vaccine injection: study protocol for a multicenter, three-arm, blinded randomized controlled trial Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao, Xi Chen, Chang Su, Xuanyu Wu, Maolan Zhao, Sihan Hu, Hanwen Lin, Jiali Huang, Guo Xu, Qinxiu Zhang, Luyun Jiang
107 [GO] 2021―Nov―23 Treatment effect of nafamostat mesylate in patients with COVID-19 pneumonia: study protocol for a randomized controlled trial Kyunglan Moon, Kyung-Wook Hong, In-Gyu Bae
108 [GO] 2021―Nov―15 Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: a double-blind, placebo-controlled randomized clinical trial Berta Grau-Pujol, Daniel Camprubí-Ferrer, Helena Marti-Soler, Marc Fernández-Pardos, Clara Carreras-Abad, Maria Velasco-de Andrés, Elisabet Ferrer, Magdalena Muelas-Fernandez, Sophie Jullien, Giuseppe Barilaro, Sara Ajanovic, Isabel Vera, Laura Moreno, Eva Gonzalez-Redondo, Núria Cortes-Serra, Montserrat Roldán, Ana Artes-de Arcos, Isabel Mur, Pere Domingo, Felipe Garcia, Caterina Guinovart, Jose Muñoz
109 [GO] 2021―Nov―14 The effect of supplementation with vitamins A, B, C, D, and E on disease severity and inflammatory responses in patients with COVID-19: a randomized clinical trial Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh, Danesh Soltani
110 [GO] 2021―Nov―08 Definitions and elements of endpoints in phase III randomized trials for the treatment of COVID-19: a cross-sectional analysis of trials registered in ClinicalTrials.gov Kentaro Sakamaki, Yukari Uemura, Yosuke Shimizu
111 [GO] 2021―Oct―23 Adapting the design of a Web-based decision support clinical trial during the COVID-19 pandemic Jessica Meline, Jason M. Prigge, Debbie Dye, Julie Rieder, Onur Asan, Sumedha Chhatre, Liana Fraenkel, Jeffrey D. Kravetz, Keri L. Rodriguez, Jeff Whittle, Dana Kaminstein, Marilyn M. Schapira
112 [GO] 2021―Oct―21 A trial platform to assess approved SARS-CoV-2 vaccines in immunocompromised patients: first sub-protocol for a pilot trial comparing the mRNA vaccines Comirnaty® and COVID-19 mRNA Vaccine Moderna® Benjamin Speich, Frédérique Chammartin, Daniel Smith, Marcel P. Stoeckle, Patrizia Amico, Anna L. Eichenberger, Barbara Hasse, Macé M. Schuurmans, Thomas Müller, Michael Tamm, Michael Dickenmann, Irene A. Abela, Alexandra Trkola, Hans H. Hirsch, Oriol Manuel, Matthias Cavassini, Lars G. Hemkens, Matthias Briel, Nicolas J. Mueller, Andri Rauch, Huldrych F. Günthard, Michael T. Koller, Heiner C. Bucher, Katharina Kusejko
113 [GO] 2021―Oct―21 Innovative clinical trial design and delivery: a phase 3 COVID-19 post-exposure prophylaxis study in skilled nursing and assisted living facilities (BLAZE-2) Jack Knorr, Jay L. Tuttle, Janelle A. Sabo, Dawn H. East, Karen L. Price, Lei Shen
114 [GO] 2021―Oct―11 Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial Jean-Christophe Richard, Hodane Yonis, Laurent Bitker, Sylvain Roche, Florent Wallet, Claire Dupuis, Hassan Serrier, Laurent Argaud, Guillaume Thiery, Bertrand Delannoy, Christian Pommier, Paul Abraham, Michel Muller, Frederic Aubrun, Florian Sigaud, Guillaume Rigault, Emilie Joffredo, Mehdi Mezidi, Nicolas Terzi, Muriel Rabilloud
115 [GO] 2021―Oct―11 A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the Remote Early Detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin, Diederick E. Grobbee, Spiros Denaxas, Johannes B. Reitsma, Christian Simon, Alison Kuchta, Pieter Stolk, George Downward, René van Lier, Jakob Kjellberg, Martin Risch, Kirsten Grossmann, David Conen, Stefanie Aeschbacher
116 [GO] 2021―Oct―07 COVID-19-related research in Africa: a cross-sectional review of the International Clinical Trial Registration Platform (ICTRP) Bassey Edem, Victor Williams, Chukwuemeka Onwuchekwa, Ama Umesi, Marianne Calnan
117 [GO] 2021―Oct―04 A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol I. García-García, P. Guerra-García, C. Ferreras, A. M. Borobia, A. J. Carcas, J. Queiruga-Parada, J. L. Vicario, I. Mirones, C. Solano, C. Eguizabal, B. Soria, A. Pérez-Martínez
118 [GO] 2021―Sep―26 Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling Andreas Deckert, Simon Anders, Manuela De Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Matthias Meurer, Robin Burk, Matthias Sand, Lisa Koeppel, Lena Maier Hein, Tobias Roß, Tim Adler, Tobias Siems, Lucia Brugnara, Stephan Brenner, Konrad Herbst, Daniel Kirrmaier, Yuanqiang Duan, Svetlana Ovchinnikova, Kathleen Boerner, Michael Marx, Hans-Georg Kräusslich, Michael Knop, Till Bärnighausen, Claudia Denkinger
119 [GO] 2021―Sep―15 Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli, P. Balaji
120 [GO] 2021―Sep―15 Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab, Adeen Akmal, Zeeshan Shaukat, Zain ul Abdin, Ayesha Khaqan, Shahroze Arshad, Muhammad Abdul Rehman Virk, Mehak Gul, Abeer bin Awais, Muhammad Hassan, Noman Khalid, Qurrat Ul Ain Iqbal, Tausif Ahmad, Muaaz Akram, Ameer Muhammad, Musa Khalil, Aneeq Aslam, Muhammad Umer, Syed Sami Hussain Sherazi, Zartasha Safdar, Sohail Ahmad, Muhammad Bilal, Muhammad Nauman Zahid, Abdulrahman E. Koshak, Abubakar Hilal, Ahmad Azam Malik, Usman Iqbal, Atif Amin Baig, Yaser Masuod Alahmadi, Ayesha Humayun, Amber Malik, Ali Ahmad, Muhammad Ashraf, Qazi Abdul Saboor, Mateen Izhar, Arz Muhammad, Kanwal Hayat, Ghazala Amjad, Misbah Kousar, Umair Hafeez, Tayyab Mughal, Tayyaba Muzafar, Sibgha Zulfiqar, Saadia Shahzad Alam, Muhammad Imran Anwar, Amber Malik, Talha Mahmud, Ali Arshad, Khawar Nawaz, Muhammad Ismail Khalid Yousaf
121 [GO] 2021―Sep―15 Vaccine trials during a pandemic: potential approaches to ethical dilemmas Manaf Alqahtani, Saad I. Mallah, Nigel Stevenson, Sally Doherty
122 [GO] 2021―Sep―08 Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19 Shakira Milton, Jennifer McIntosh, Lucy Boyd, Napin Karnchanachari, Finlay Macrae, Jon David Emery
123 [GO] 2021―Sep―07 The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic Hans H. Liu, Michael D. Ezekowitz, Michele Columbo, Oneib Khan, Jack Martin, Judith Spahr, David Yaron, Lisa Cushinotto, Luciano Kapelusznik
124 [GO] 2021―Sep―06 The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care-COLCHICOVID study Elena Bustamante Estebanez, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, Juan Carlos López Caro, Jonathan Diez Vallejo, Marta Fernandez Sampedro, Pedro Muñoz Cacho, Carlos Richard Espiga, María Mar García Saiz
125 [GO] 2021―Sep―06 The effect of framing and communicating COVID-19 vaccine side-effect risks on vaccine intentions for adults in the UK and the USA: A structured summary of a study protocol for a randomized controlled trial Nikkil Sudharsanan, Caterina Favaretti, Violetta Hachaturyan, Till Bärnighausen, Alain Vandormael
126 [GO] 2021―Sep―03 Antiviral and immunomodulatory interferon-beta in high-risk COVID-19 patients: a structured summary of a study protocol for a randomised controlled trial Eleonora Aricò, Luciano Castiello, Laura Bracci, Francesca Urbani, Flavia Lombardo, Ilaria Bacigalupo, Antonio Ancidoni, Nicola Vanacore, Alessandro Falcione, Chiara Reggiani, Giovanni Marco Dutti, Maria Grazia Maglie, Ombretta Papa, Pier Luigi Bartoletti, Giuseppina Ozzella, Nazario Bevilacqua, Emanuele Nicastri, Filippo Belardelli, Giuseppe Sconocchia
127 [GO] 2021―Aug―28 Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients-a double-blind, placebo-controlled, clinical trial Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayanan, Vivek Gupta, Rashmi Upadhayay, Jitender Kumar, Sathiyarajeswaran Parameswaran
128 [GO] 2021―Aug―28 Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial Carinna Hockham, Sradha Kotwal, Arlen Wilcox, Abhinav Bassi, James McGree, Carol Pollock, Louise M. Burrell, Nikita Bathla, Mallikarjuna Kunigari, Vinay Rathore, Michael John, Enmoore Lin, Christine Jenkins, Angus Ritchie, Andrew McLachlan, Thomas Snelling, Mark Jones, Vivekanand Jha, Meg Jardine
129 [GO] 2021―Aug―28 Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures Silke van Koningsbruggen-Rietschel, Fiona Dunlevy, Veerle Bulteel, Kate Hayes, Anne Verbrugge, Hettie M. Janssens, Nadine Dufeu, Nicholas J. Simmonds, Lieven J. Dupont, Damian G. Downey
130 [GO] 2021―Aug―23 Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2 Wendy Holman, Wayne Holman, Stacy McIntosh, Wendy Painter, George Painter, Jim Bush, Oren Cohen
131 [GO] 2021―Aug―21 Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial Lina Jovarauskaite, Austeja Dumarkaite, Inga Truskauskaite-Kuneviciene, Ieva Jovaisiene, Gerhard Andersson, Evaldas Kazlauskas
132 [GO] 2021―Aug―19 SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion Sarah Halford, Susan Wan, Ilaria Dragoni, Julie Silvester, Bobojon Nazarov, Daniel Anthony, Suzie Anthony, Emma Ladds, John Norrie, Kevin Dhaliwal
133 [GO] 2021―Aug―12 Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial Átila Alexandre Trapé, Marta Camacho-Cardenosa, Alba Camacho-Cardenosa, Eugenio Merellano-Navarro, Jhennyfer Aline Lima Rodrigues, Elisangela Aparecida da Silva Lizzi, Carlos Arterio Sorgi, Marcelo Papoti, Javier Brazo-Sayavera
134 [GO] 2021―Jul―28 Resiliency Engagement and Care in Health (REaCH): a telephone befriending intervention for upskilled rural youth in the context of COVID-19 pandemic-study protocol for a multi-centre cluster randomised controlled trial Saju Madavanakadu Devassy, Komal Preet Allagh, Anuja Maria Benny, Lorane Scaria, Natania Cheguvera, I. P. Sunirose
135 [GO] 2021―Jul―26 AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter Gareth O. Griffiths, Richard FitzGerald, Thomas Jaki, Andrea Corkhill, Helen Reynolds, Sean Ewings, Susannah Condie, Emma Tilt, Lucy Johnson, Mike Radford, Catherine Simpson, Geoffrey Saunders, Sara Yeats, Pavel Mozgunov, Olana Tansley-Hancock, Karen Martin, Nichola Downs, Izabela Eberhart, Jonathan W. B. Martin, Cristiana Goncalves, Anna Song, Tom Fletcher, Kelly Byrne, David G. Lalloo, Andrew Owen, Michael Jacobs, Lauren Walker, Rebecca Lyon, Christie Woods, Jennifer Gibney, Justin Chiong, Nomathemba Chandiwana, Shevin Jacob, Mohammed Lamorde, Catherine Orrell, Munir Pirmohamed, Saye Khoo
136 [GO] 2021―Jul―24 Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial Antonio Ojeda, Andrea Calvo, Tomas Cuñat, Ricard Mellado Artigas, Oscar Comino-Trinidad, Jorge Aliaga, Marilyn Arias, Maribel Ahuir, Carlos Ferrando, Christian Dürsteler
137 [GO] 2021―Jul―22 Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial Wen Zhang, Qin Xie, Xiaoming Xu, Shuting Sun, Tian Fan, Xinxin Wu, Yao Qu, Jinhua Che, Tingrong Huang, Huacheng Li, You Zheng, Chao Jiang, Bangjiang Fang, Shuang Zhou
138 [GO] 2021―Jul―22 A cultural experience to support mental health in people aged 16-24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial Rebecca J. Syed Sheriff, Matti Vuorre, Evgenia Riga, Andrew K. Przybylski, Helen Adams, Catherine J. Harmer, John R. Geddes
139 [GO] 2021―Jul―16 Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial Marian Fitzgibbon, Lara Blumstein, Linda Schiffer, Mirjana A. Antonic, Andrew McLeod, Roxanne Dakers, Leo Restrepo, Elizabeth A. Boots, Jennifer C. Sanchez-Flack, Lisa Tussing-Humphreys, Melissa Lamar
140 [GO] 2021―Jul―13 The effectiveness of a psycho-education intervention on mental health literacy in communities affected by the COVID-19 pandemic-a cluster randomized trial of 24 villages in central Uganda-a research protocol Dickens Akena, Ronald Kiguba, Wilson W. Muhwezi, Brendan Kwesiga, Gwendolyne Kigozi, Noeline Nakasujja, Hafsa Lukwata
141 [GO] 2021―Jul―09 Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents Bronwyn Myers, Claire van der Westhuizen, Megan Pool, Nancy Hornsby, Katherine R. Sorsdahl
142 [GO] 2021―Jul―06 Evaluation of the efficacy and safety of recombinant erythropoietin on the improvement of hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Maryam Haddad, Mohsen Arabi, Mitra KazemiJahromi
143 [GO] 2021―Jul―06 Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial Gholamreza Askari, Babak Alikiaii, Davood Soleimani, Amirhossein Sahebkar, Mahdiye Mirjalili, Awat Feizi, Bijan Iraj, Mohammad Bagherniya
144 [GO] 2021―Jul―05 Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial Nicholas G. Nickols, Matthew B. Goetz, Christopher J. Graber, Debika Bhattacharya, Guy Soo Hoo, Matthew Might, David B. Goldstein, Xinchen Wang, Rachel Ramoni, Kenute Myrie, Samantha Tran, Leila Ghayouri, Sonny Tsai, Michelle Geelhoed, Danil Makarov, Daniel J. Becker, Jun-Chieh Tsay, Melissa Diamond, Asha George, Mohammad Al-Ajam, Pooja Belligund, R. Bruce Montgomery, Elahe A. Mostaghel, Carlie Sulpizio, Zhibao Mi, Ellen Dematt, Joseph Tadalan, Leslie E. Norman, Daniel Briones, Christina E. Clise, Zachary W. Taylor, Jeffrey R. Huminik, Kousick Biswas, Matthew B. Rettig
145 [GO] 2021―Jun―22 A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin, Diederick E. Grobbee, Spiros Denaxas, Johannes B. Reitsma, Christian Simon, Alison Kuchta, Pieter Stolk, George Downward, René van Lier, Jakob Kjellberg, Martin Risch, Kirsten Grossmann, David Conen, Stefanie Aeschbacher
146 [GO] 2021―Jun―07 Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial Sarah Naja, Rowaida Elyamani, Mohamad Chehab, Mohamed Siddig, Abdullah Al Ibrahim, Tagreed Mohamad, Rajvir Singh, Iheb Bougmiza
147 [GO] 2021―Jun―05 Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK - experience from the ActWELL trial” Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill, Shaun Treweek
148 [GO] 2021―Jun―03 Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial Babita Yadav, Amit Rai, Pallavi Suresh Mundada, Richa Singhal, B. C. S. Rao, Rakesh Rana, Narayanam Srikanth
149 [GO] 2021―May―30 Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic Amandine Gagneux-Brunon, Clémentine Schilte, Arnauld Garcin, Nathalie Jolly, Muriel Vray, Laura Schaeffer, Xavier Duval, Bruno Hoen, Elisabeth Botelho-Nevers
150 [GO] 2021―May―25 The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization David T. Huang, Erin K. McCreary, J. Ryan Bariola, Richard J. Wadas, Kevin E. Kip, Oscar C. Marroquin, Stephen Koscumb, Kevin Collins, Judith A. Shovel, Mark Schmidhofer, Mary Kay Wisniewski, Colleen Sullivan, Donald M. Yealy, Meredith Axe, David A. Nace, Ghady Haidar, Tina Khadem, Kelsey Linstrum, Graham M. Snyder, Christopher W. Seymour, Stephanie K. Montgomery, Bryan J. McVerry, Lindsay Berry, Scott Berry, Russell Meyers, Alexandra Weissman, Octavia M. Peck-Palmer, Alan Wells, Robert Bart, Debbie L. Albin, Tami Minnier, Derek C. Angus
151 [GO] 2021―May―19 Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: study protocol for a randomized controlled trial H. Rahimi, A. Allahyari, S. Ataei Azimi, M. Kamandi, Z. Mozaheb, F. Zemorshidi, M. Khadem-Rezaiyan, A. Bary, M. Seddigh-Shamsi, M. Moeini Nodeh
152 [GO] 2021―May―17 Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial Verena Keitel, Björn Jensen, Torsten Feldt, Johannes C. Fischer, Johannes G. Bode, Christiane Matuschek, Edwin Bölke, Wilfried Budach, Christian Plettenberg, Kathrin Scheckenbach, Detlef Kindgen-Milles, Jörg Timm, Lisa Müller, Henrike Kolbe, Andreas Stöhr, Christian Calles, Andreas Hippe, Pablo Verde, Christoph D. Spinner, Jochen Schneider, Timo Wolf, Winfried V. Kern, Jacob Nattermann, Alexander Zoufaly, Christian Ohmann, Tom L
153 [GO] 2021―May―17 Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial Alonso Soto, Fiorella Krapp, Alex Vargas, Lucía Cabrejos, Enrique Argumanis, Patricia L. García, Karina Altamirano, Martín Montes, Pamela R. Chacón-Uscamaita, Patricia J. García
154 [GO] 2021―May―05 Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial Johan H. Vlake, Jasper Van Bommel, Evert-Jan Wils, Tim I. M. Korevaar, Merel E. Hellemons, Anna F. C. Schut, Joost A. M. Labout, Lois L. H. Schreuder, Diederik Gommers, Michel E. Van Genderen
155 [GO] 2021―May―04 Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial Philippe Bégin, Jeannie Callum, Nancy M. Heddle, Richard Cook, Michelle P. Zeller, Alan Tinmouth, Dean A. Fergusson, Melissa M. Cushing, Marshall J. Glesby, Michaël Chassé, Dana V. Devine, Nancy Robitalle, Renée Bazin, Nadine Shehata, Andrés Finzi, Allison McGeer, Damon C. Scales, Lisa Schwartz, Alexis F. Turgeon, Ryan Zarychanski, Nick Daneman, Richard Carl, Luiz Amorim, Caroline Gabe, Martin Ellis, Bruce S. Sachais, Kent Cadogan Loftsgard, Erin Jamula, Julie Carruthers, Joanne Duncan, Kayla Lucier, Na Li, Yang Liu, Chantal Armali, Amie Kron, Dimpy Modi, Marie-Christine Auclair, Sabrina Cerro, Meda Avram, Donald M. Arnold
156 [GO] 2021―Apr―29 The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial Ben Young, Marie Kotzur, Lauren Gatting, Carissa Bonner, Julie Ayre, Alex McConnachie, Carys Batcup, Kirsten McCaffery, Ronan O’Carroll, Kathryn A. Robb
157 [GO] 2021―Apr―28 Efficacy and safety of nelfinavir in asymptomatic and mild COVID-19 patients: a structured summary of a study protocol for a multicenter, randomized controlled trial Naoki Hosogaya, Taiga Miyazaki, Yuri Fukushige, Sachiko Takemori, Shinpei Morimoto, Hiroshi Yamamoto, Makoto Hori, Tomoya Kurokawa, Yohei Kawasaki, Michiko Hanawa, Yasuhisa Fujii, Hideki Hanaoka, Shingo Iwami, Koichi Watashi, Satoshi Yamagoe, Yoshitsugu Miyazaki, Takaji Wakita, Koichi Izumikawa, Katsunori Yanagihara, Hiroshi Mukae, Shigeru Kohno
158 [GO] 2021―Apr―28 Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial Silvia Molino, Andrea Pisarevsky, Fabiana Lopez Mingorance, Patricia Vega, Juan Pablo Stefanolo, Julieta Repetti, Guillermina Ludueña, Pablo Pepa, Juan Ignacio Olmos, Marcelo Rodriguez Fermepin, Tatiana Uehara, Sonia Villapol, Tor Savidge, Todd Treangen, Elisa Viciani, Andrea Castagnetti, Maria Marta Piskorz
159 [GO] 2021―Apr―20 The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond Sonika Sethi, Aditi Kumar, Anandadeep Mandal, Mohammed Shaikh, Claire A. Hall, Jeremy M. W. Kirk, Paul Moss, Matthew J. Brookes, Supratik Basu
160 [GO] 2021―Apr―19 A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial Natalie L. McEvoy, Jennifer L. Clarke, Oliver J. Mc Elvaney, Oisin F. Mc Elvaney, Fiona Boland, Deirdre Hyland, Pierce Geoghegan, Karen Donnelly, Oisin Friel, Ailbhe Cullen, Ann M. Collins, Daniel Fraughen, Ignacio Martin-Loeches, Martina Hennessy, John G. Laffey, Noel G. Mc Elvaney, Gerard F. Curley
161 [GO] 2021―Apr―16 Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency Rachel Lowe, Christy Barlow, Barry Lloyd, Julie Latchem-Hastings, Vincent Poile, Charlotte Scoble, Andrew Dean-Young, Kate Button, Rebecca Playle, Monica Busse
162 [GO] 2021―Apr―14 Conducting clinical trials during the COVID-19 pandemic-a collaborative trial network response Laura Robison, Yeoungjee Cho, Andrea K. Viecelli, David W. Johnson, Carmel M. Hawley, Andrea Valks, Peta-Anne Paul-Brent, Ruth Stastny, Julie Varghese, Charani Kiriwandeniya, Elaine M. Pascoe, Liza A. Vergara, Magid A. Fahim, Neil Boudville, Rathika Krishnasamy, Donna Reidlinger
163 [GO] 2021―Apr―14 Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic Sharon B. Love, Emma Armstrong, Carrie Bayliss, Melanie Boulter, Lisa Fox, Joanne Grumett, Patricia Rafferty, Barbara Temesi, Krista Wills, Andrea Corkhill
164 [GO] 2021―Apr―13 A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial Murat Akova, Serhat Unal
165 [GO] 2021―Apr―12 The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial Arash Rahimi, Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Mohsen Arabi, Mitra KazemiJahromi
166 [GO] 2021―Apr―12 Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial Nikhil Vergis, Rachel Phillips, Victoria Cornelius, Alexia Katsarou, Taryn Youngstein, Lucy Cook, Michelle Willicombe, Clio Pilay, Tina Shturova, Melanie Almonte, Asad Charania, Richard Turner, Onn Min Kon, Graham Cooke, Mark Thursz, Svetlana Cherlin, James Wason, Dragana Milojkovic, Andew J. Innes, Nichola Cooper
167 [GO] 2021―Apr―12 Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial Ana Cristina Carvalho, Jorge Moreira, Pedro Cubelo, Pedro Cantista, Catarina Aguiar Branco, Bruno Guimarães
168 [GO] 2021―Apr―10 Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial Katarzyna Kostyrka-Allchorne, Cathy Creswell, Sarah Byford, Crispin Day, Kimberley Goldsmith, Marta Koch, Walter Muruet Gutierrez, Melanie Palmer, Jasmine Raw, Olly Robertson, James Shearer, Adrienne Shum, Petr Slovak, Polly Waite, Edmund J. S. Sonuga-Barke
169 [GO] 2021―Apr―09 Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial Patricia J. Garcia, Hansel Mundaca, Cesar Ugarte-Gil, Patricia Leon, German Malaga, Carlos Chaccour, Cesar P. Carcamo
170 [GO] 2021―Apr―09 Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial Jeremy Horwood, Melanie Chalder, Ben Ainsworth, James Denison-Day, Frank de Vocht, Martha M. C. Elwenspoek, Pippa Craggs, Rachel Denholm, Jonathan Sterne, Cathy Rice, Sascha Miller, Beth Stuart, Paul Little, Michael Moore, Merlin Willcox, John Macleod, Martin Gullford, Kate Morton, Lauren Towler, Nick Francis, Richard Amlôt, Lucy Yardley
171 [GO] 2021―Apr―08 The COVID-19 pandemic and new clinical trial activations Joseph M. Unger, Hong Xiao
172 [GO] 2021―Apr―07 Correction to: Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu, Xiaojia Ni
173 [GO] 2021―Apr―02 Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study John P. Haran, Jose C. Pinero, Yan Zheng, Norma Alonzo Palma, Mark Wingertzahn
174 [GO] 2021―Apr―02 Effects of pomegranate juice (Punica Granatum) on inflammatory biomarkers and complete blood count in patients with COVID-19: a structured summary of a study protocol for a randomized clinical trial Mojtaba Yousefi, Mohammadreza Sadriirani, Azizollah PourMahmoudi, Sara Mahmoodi, Bahar Samimi, Mahboobe Hosseinikia, Zaker Saeedinezhad, Seyed Bahman Panahande
175 [GO] 2021―Mar―29 COVID-19: underpowered randomised trials, or no randomised trials? Atle Fretheim
176 [GO] 2021―Mar―24 The time is now: role of pragmatic clinical trials in guiding response to global pandemics Aws Almufleh, Jacob Joseph
177 [GO] 2021―Mar―22 Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial Darrell H. S. Tan, Adrienne K. Chan, Peter Jüni, George Tomlinson, Nick Daneman, Sharon Walmsley, Matthew Muller, Rob Fowler, Srinivas Murthy, Natasha Press, Curtis Cooper, Todd Lee, Tony Mazzulli, Allison McGeer
178 [GO] 2021―Mar―20 Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults Wesley H. Self, Thomas G. Stewart, Allison P. Wheeler, Wissam El Atrouni, Amanda J. Bistran-Hall, Jonathan D. Casey, Vince D. Cataldo, James D. Chappell, Claudia S. Cohn, Jessica B. Collins, Mark R. Denison, Marjolein de Wit, Sheri L. Dixon, Abhijit Duggal, Terri L. Edwards, Magali J. Fontaine, Adit A. Ginde, Michelle S. Harkins, Thelma Harrington, Estelle S. Harris, Daanish Hoda, Tina S. Ipe, Stuti J. Jaiswal, Nicholas J. Johnson, Alan E. Jones, Maryrose Laguio-Vila, Christopher J. Lindsell, Jason Mallada, Manoj J. Mammen, Ryan A. Metcalf, Elizabeth A. Middleton, Simon Mucha, Hollis R. O’Neal, Sonal R. Pannu, Jill M. Pulley, Xian Qiao, Jay S. Raval, Jillian P. Rhoads, Harry Schrager, Carl Shanholtz, Nathan I. Shapiro, Stephen J. Schrantz, Isaac Thomsen, Krista K. Vermillion, Gordon R. Bernard, Todd W. Rice
179 [GO] 2021―Mar―16 COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial Karin Welén, Anna K Överby, Clas Ahlm, Eva Freyhult, David Robinsson, Anna Jonsson Henningsson, Johan Stranne, Daniel Bremell, Martin Angelin, Elisabeth Lindquist, Robert Buckland, Camilla Thellenberg Carlsson, Karlis Pauksens, Anna Bill-Axelsson, Olof Akre, Cecilia Ryden, Magnus Wagenius, Anders Bjartell, Anna C. Nilsson, Johan Styrke, Johanna Repo, Åse Östholm Balkhed, Katarina Niward, Magnus Gisslén, Andreas Josefsson
180 [GO] 2021―Mar―10 Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG - RAPID Trial): A structured summary of a study protocol for a randomised controlled trial Michelle Sholzberg, Grace H. Tang, Elnara Negri, Hassan Rahhal, Lisa Baumann Kreuziger, Carlos E. Pompilio, Paula James, Michael Fralick, Musaad AlHamzah, Faris Alomran, Eric Tseng, Gloria Lim, David Lillicrap, Marc Carrier, Fionnuala Ní Áinle, Andrew Beckett, Bruno R. da Costa, Kevin Thorpe, Saskia Middeldorp, Agnes Lee, Mary Cushman, Peter Jüni
181 [GO] 2021―Mar―09 Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial Benjamin Gaborit, Bernard Vanhove, Marie-Anne Vibet, Aurélie Le Thuaut, Karine Lacombe, Vincent Dubee, Florence Ader, Virginie Ferre, Eric Vicaut, Jéremie Orain, Morgane Le Bras, Anne Omnes, Laetitia Berly, Alexandra Jobert, Pascale Morineau-Le Houssine, Karine Botturi, Régis Josien, Laurent Flet, Nicolas Degauque, Sophie Brouard, Odile Duvaux, Alexandra Poinas, François Raffi
182 [GO] 2021―Mar―08 Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial Li-An K. Brown, Nick Freemantle, Judy Breuer, Hakim-Moulay Dehbi, Kashfia Chowdhury, Gemma Jones, Felicia Ikeji, Amalia Ndoutoumou, Krishneya Santhirakumar, Nicky Longley, Anna M. Checkley, Joseph F. Standing, David M. Lowe
183 [GO] 2021―Mar―08 Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial Ali Ameri, Masoomeh Frouz Asadi, Manoochehr Kamali, Majid Vatankhah, Ava Ziaei, Omid Safa, Masoomeh Mahmudi, Mohammad Fathalipour
184 [GO] 2021―Mar―05 Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu, Xiaojia Ni
185 [GO] 2021―Mar―05 Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos, W. Janssens
186 [GO] 2021―Mar―01 Effect of dexamethasone in patients with ARDS and COVID-19 - prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised controlled trial Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl, Jozef Klučka, Roman Gál, Mervyn Singer
187 [GO] 2021―Mar―01 An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial Noemi Anja Brog, Julia Katharina Hegy, Thomas Berger, Hansjörg Znoj
188 [GO] 2021―Mar―01 Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial Aurélien Mazeraud, Bruno Gonçalves, Philippe Aegerter, Letizia Mancusi, Christine Rieu, Fernando Bozza, Khaoussou Sylla, Shidasp Siami, Tarek Sharshar
189 [GO] 2021―Feb―25 Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao, Xi Chen, Chang Su, Xuanyu Wu, Maolan Zhao, Sihan Hu, Hanwen Lin, Jiali Huang, Guo Xu, Qinxiu Zhang, Luyun Jiang
190 [GO] 2021―Feb―20 COVID-19 trials: declarations of data sharing intentions at trial registration and at publication Rebecca Li, Megan von Isenburg, Marcia Levenstein, Stan Neumann, Julie Wood, Ida Sim
191 [GO] 2021―Feb―17 Correction to: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations
192 [GO] 2021―Feb―11 Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial Marie Muller, François Lefebvre, Marie-Line Harlay, Ludovic Glady, Guillaume Becker, Charlotte Muller, O꾪 Aberkane, Mira Tawk, Madoé Julians, Arnaud Romoli, Stéphane Hecketsweiler, Francis Schneider, Julien Pottecher, Thiên-Nga Chamaraux-Tran
193 [GO] 2021―Feb―10 A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Iqra Farooq, Muhammad Ghufran, Romaisa Arshad Khokhar, Muhammad Kiwan Akram, Iqra Shahid, Muhammad Sohaib Ur Rehman, Rutaba Akmal, Arbaz Tahir, Ayesha Zahid, Sidra Ashraf, Sundas Rafique, Nazish Matti, Muhammad Faisal Nadeem, Ayesha Humayun, Amber Malik, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar
194 [GO] 2021―Feb―09 Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2-azithromycin trial Iwein Gyselinck, Laurens Liesenborgs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos, W. Janssens
195 [GO] 2021―Feb―05 Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial Mona Aflaki, Alexandria Flannery, João Pedro Ferreira, Matthew Pellan Cheng, Nadine Kronfli, Ariane Marelli, Faiez Zannad, James Brophy, Jon Afillalo, Thao Huynh, Nadia Giannetti, Amal Bessissow, Justin A. Ezekowitz, Renato D. Lopes, Andrew P. Ambrosy, Morgan Craig, Abhinav Sharma
196 [GO] 2021―Feb―05 Remote data collection during COVID-19 restrictions: an example from a refugee and asylum-seeker participant group in the UK Lauren Walker, Della Bailey, Rachel Churchill, Emily Peckham
197 [GO] 2021―Feb―01 Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Livia Mitchiguian Hotta, Ana Elisa Madureira Padula, Amarilys de Toledo Cesar, José Nelson Martins Diniz, Crislaine Aparecida Antonio Mestre, Katia Regina Spiller, Lidiamara Soares, Helen de Freitas Santos, Edson Zangiacomi Martinez
198 [GO] 2021―Feb―01 Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials Lajos Szakó, Nelli Farkas, Szabolcs Kiss, Szilárd Váncsa, Noémi Zádori, Nóra Vörhendi, Bálint Erőss, Péter Hegyi, Hussain Alizadeh
199 [GO] 2021―Feb―01 High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial (CARED-TRIAL) Javier Mariani, Carlos Tajer, Laura Antonietti, Felipe Inserra, León Ferder, Walter Manucha
200 [GO] 2021―Jan―28 Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations
201 [GO] 2021―Jan―26 Correction to: Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield, Rachel Potter, James Mason, Ranjit Lall, Kate Seers, Martin Underwood
202 [GO] 2021―Jan―26 Early use of corticosteroids in non-critical patients with COVID-19 pneumonia (PREDCOVID): a structured summary of a study protocol for a randomised controlled trial Mauricio Salinas, Paulette Andino, Leonor Palma, Javiera Valencia, Elizabeth Figueroa, Jhonatan Ortega
203 [GO] 2021―Jan―20 Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial Elena Diago-Sempere, José Luis Bueno, Aránzazu Sancho-López, Elena Múñez Rubio, Ferrán Torres, Rosa Malo de Molina, Ana Fernández-Cruz, Isabel Salcedo de Diego, Ana Velasco-Iglesias, Concepción Payares-Herrera, Inmaculada Casas Flecha, Cristina Avendaño-Solà, Rafael Duarte Palomino, Antonio Ramos-Martínez, Belén Ruiz-Antorán
204 [GO] 2021―Jan―20 Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial Eli Mansour, Flávia F. Bueno, José C. de Lima-Júnior, Andre Palma, Milena Monfort-Pires, Bruna Bombassaro, Eliana P. Araujo, Ana Flavia Bernardes, Raisa G. Ulaf, Thyago A. Nunes, Luciana C. Ribeiro, Antônio Luís E. Falcão, Thiago Martins Santos, Plinio Trabasso, Rachel P. Dertkigil, Sergio S. Dertkigil, Rafael P. Maia, Tatiana Benaglia, Maria Luiza Moretti, Licio A. Velloso
205 [GO] 2021―Jan―18 Managing clinical trials during COVID-19: experience from a clinical research facility Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley, Joseph A. Eustace
206 [GO] 2021―Jan―18 Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial Guitti Pourdowlat, Seyed Ruhollah Mousavinasab, Behrooz Farzanegan, Alireza Kashefizadeh, Zohreh Akhoundi Meybodi, Maedeh Jafarzadeh, Shadi Baniasadi
207 [GO] 2021―Jan―15 Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs Florence Rodgers, Toby Pepperrell, Sarai Keestra, Victoria Pilkington
208 [GO] 2021―Jan―11 Hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting (LIBERTY): A structured summary of a study protocol for a randomised controlled trial Petri J. Vainio, Pauliina Hietasalo, Anna-Liisa Koivisto, Susanna Kääriäinen, Jari Turunen, Mika Virtala, Jouni Vuorinen, Mika Scheinin
209 [GO] 2021―Jan―11 Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet, S. Agus
210 [GO] 2021―Jan―11 Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López, Julio Sánchez Álvarez
211 [GO] 2021―Jan―08 Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial Andreas Deckert, Simon Anders, Manuela de Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Kathleen Boerner, Matthias Meurer, Konrad Herbst, Matthias Sand, Lisa Koeppel, Tobias Siems, Lucia Brugnara, Stephan Brenner, Robin Burk, Dan Lou, Daniel Kirrmaier, Yuanqiang Duan, Svetlana Ovchinnikova, Michael Marx, Hans Georg Kräusslich, Michael Knop, Till Bärnighausen, Claudia Denkinger
212 [GO] 2021―Jan―06 Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial Concepción Payares-Herrera, María E. Martínez-Muñoz, Inés Lipperheide Vallhonrat, Rosa Malo de Molina, Manuel Pérez Torres, Andrea Trisan, Isabel Salcedo de Diego, Rosalía Alonso, Rocío Zafra, Trinidad Donaire, Rocío Sánchez, Juan José Rubio, Rafael F. Duarte Palomino, Cristina Avendaño Solá
213 [GO] 2021―Jan―06 Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield, Rachel Potter, James Mason, Ranjit Lall, Kate Seers, Martin Underwood
214 [GO] 2021―Jan―06 A structured summary of a study protocol for a multi-center, randomized controlled trial (RCT) of COVID-19 prevention with Kampo medicines (Integrative Management in Japan for Epidemic Disease by prophylactic study: IMJEDI P1 study) Takao Namiki, Shin Takayama, Ryutaro Arita, Tadashi Ishii, Mosaburo Kainuma, Toshiaki Makino, Masaru Mimura, Tetsuhiro Yoshino, Tatsuya Nogami, Makoto Arai, Juichi Sato, Koichiro Tanaka, Hajime Nakae, Hidetoshi Igari, Yoshihito Ozawa, Yuki Shiko, Yohei Kawasaki, Masahiko Nezu, Takashi Ito
215 [GO] 2021―Jan―04 Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial Mohammad Jahid Hasan, S. K. Nurul Fattah Rumi, Sultana Sahana Banu, A. K. M. Nasir Uddin, Md Shahnoor Islam, Mostafa Kamal Arefin
216 [GO] 2021―Jan―04 Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial Adeniyi Olagunju, Adeola Fowotade, Ajibola Olagunoye, Temitope Olumuyiwa Ojo, Bolanle Olufunlola Adefuye, Adeniyi Francis Fagbamigbe, Akindele Olupelumi Adebiyi, Omobolanle Ibitayo Olagunju, Olabode Taiwo Ladipo, Abdulafeez Akinloye, Babatunde Ayodeji Adeagbo, Adedeji Onayade, Oluseye Oladotun Bolaji, Christian Happi, Steve Rannard, Andrew Owen
217 [GO] 2021―Jan―04 The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial Fatemeh Sadat Hosseini, Alireza Malektojari, Sara Ghazizadeh, Mehdi Hassaniazad, Parivash Davoodian, Habib Dadvand, Amin Reza Nikpoor, Sara Nikoofal-Sahlabadi, Sara Kahoori, Mojtaba Sepandi, Soheil Hassanipour, Mohammad Fathalipour
218 [GO] 2021―Jan―04 Recombinant human C1 esterase inhibitor (conestat alfa) in the prevention of severe SARS-CoV-2 infection in hospitalized patients with COVID-19: A structured summary of a study protocol for a randomized, parallel-group, open-label, multi-center pilot trial (PROTECT-COVID-19) Pascal Urwyler, Panteleimon Charitos, Stephan Moser, Ingmar A. F. M. Heijnen, Marten Trendelenburg, Reto Thoma, Johannes Sumer, Adrián Camacho-Ortiz, Marcelo R. Bacci, Lars C. Huber, Melina Stüssi-Helbling, Werner C. Albrich, Parham Sendi, Michael Osthoff
219 [GO] 2020―Dec―29 Correction to: A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study T. Vanassche, M. M. Engelen, Q. Van Thillo, J. Wauters, J. Gunst, C. Wouters, C. Vandenbriele, S. Rex, L. Liesenborghs, A. Wilmer, P. Meersseman, G. Van den Berghe, D. Dauwe, G. Verbeke, M. Thomeer, T. Fivez, D. Mesotten, D. Ruttens, L. Heytens, I. Dapper, S. Tuyls, B. De Tavernier, P. Verhamme
220 [GO] 2020―Dec―28 COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial Cédric Annweiler, Mélinda Beaudenon, Jennifer Gautier, Romain Simon, Vincent Dubée, Justine Gonsard, Elsa Parot-Schinkel
221 [GO] 2020―Dec―23 Efficacy of Traditional Chinese Medicine, Maxingshigan-Weijing in the management of COVID-19 patients with severe acute respiratory syndrome: A structured summary of a study protocol for a randomized controlled trial Congcong Zeng, Zhengzhong Yuan, Xiaoqiong Pan, Jizhou Zhang, Jiahui Zhu, Fan Zhou, Zhuocheng Shan, Ye Yuan, Ren Ye, Jinguo Cheng
222 [GO] 2020―Dec―17 Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial Mahsa Miryan, Mohammad Bagherniya, Amirhossein Sahebkar, Davood Soleimani, Mohammad Hossein Rouhani, Bijan Iraj, Gholamreza Askari
223 [GO] 2020―Dec―15 An entertainment-education approach to prevent COVID-19 spread: study protocol for a multi-site randomized controlled trial Alain Vandormael, Maya Adam, Merlin Greuel, Till Bärnighausen
224 [GO] 2020―Dec―14 Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials Fatemeh Khademian, Azam Aslani, Ramin Ravangard, Peivand Bastani, Mohammad Nami, Peyman Jafari
225 [GO] 2020―Dec―14 Correction to: A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial Timothy Devos, Tatjana Geukens, Alexander Schauwvlieghe, Kevin K. Ariën, Cyril Barbezange, Myriam Cleeren, Veerle Compernolle, Nicolas Dauby, Daniël Desmecht, David Grimaldi, Bart N. Lambrecht, Anne Luyten, Piet Maes, Michel Moutschen, Marta Romano, Lucie Seyler, Michel Toungouz Nevessignsky, Katleen Vandenberghe, Johan van Griensven, Geert Verbeke, Erika Vlieghe, Jean Cyr Yombi, Laurens Liesenborghs, Peter Verhamme, Geert Meyfroidt
226 [GO] 2020―Dec―10 Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial Ahilanandan Dushianthan, Howard Clark, Jens Madsen, Robin Mogg, Lewis Matthews, Lee Berry, Jorge Bernardino de la Serna, James Batchelor, David Brealey, Tracy Hussell, Joanna Porter, Ratko Djukanovic, Martin Feelisch, Anthony Postle, Michael P. W. Grocott
227 [GO] 2020―Dec―09 Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial Katherine T. O’Donnell, Melanie Dunbar, Diana L. Speelman
228 [GO] 2020―Dec―09 A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study T. Vanassche, M. M. Engelen, Q. Van Thillo, J. Wauters, J. Gunst, C. Wouters, C. Vandenbriele, S. Rex, L. Liesenborghs, A. Wilmer, P. Meersseman, G. Van den Berghe, D. Dauwe, G. Verbeke, M. Thomeer, T. Fivez, D. Mesotten, D. Ruttens, L. Heytens, I. Dapper, S. Tuyls, B. De Tavernier, P. Verhamme
229 [GO] 2020―Dec―04 Safety and Efficacy of Ixekizumab and Antiviral Treatment for Patients with COVID-19: A structured summary of a study protocol for a Pilot Randomized Controlled Trial Panpan Liu, Zhijun Huang, Mingzhu Yin, Chun Liu, Xiang Chen, Pinhua Pan, Yehong Kuang
230 [GO] 2020―Dec―03 The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial Mahsa Miryan, Davood Soleimani, Leila Dehghani, Karim Sohrabi, Farzin Khorvash, Mohammad Bagherniya, Sayed Mazaher Sayedi, Gholamreza Askari
231 [GO] 2020―Dec―03 Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET) Jonas Tverring, Anna Åkesson, Niklas Nielsen
232 [GO] 2020―Nov―27 A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial Timothy Devos, Tatjana Geukens, Alexander Schauvlieghe, Kevin K. Ariën, Cyril Barbezange, Myriam Cleeren, Veerle Compernolle, Nicolas Dauby, Daniël Desmecht, David Grimaldi, Bart N. Lambrecht, Anne Luyten, Piet Maes, Michel Moutschen, Marta Romano, Lucie Seyler, Michel Toungouz Nevessignsky, Katleen Vandenberghe, Johan van Griensven, Geert Verbeke, Erika Vlieghe, Jean Cyr Yombi, Laurens Liesenborghs, Peter Verhamme, Geert Meyfroidt
233 [GO] 2020―Nov―26 Evaluating the efficacy and safety of the myrtle (Myrtus communis) in treatment and prognosis of patients suspected to novel coronavirus disease (COVID-19): study protocol for a randomized controlled trial Maryam Azimi, Fatemeh Sadat Hasheminasab
234 [GO] 2020―Nov―25 Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial Carina Kirstine Klarskov, Birgitte Lindegaard, Ulrik Pedersen-Bjergaard, Peter Lommer Kristensen
235 [GO] 2020―Nov―24 Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial Julio Vallejos, Rodrigo Zoni, Maria Bangher, Silvina Villamandos, Angelina Bobadilla, Fabian Plano, Claudia Campias, Evangelina Chaparro Campias, Fernando Achinelli, Hector A. Guglielmone, Jorge Ojeda, Fernanda Medina, Diego Farizano Salazar, Gerardo Andino, Natalia E. Ruiz Diaz, Pablo Kawerin, Elba Meza, Silvana Dellamea, Antonia Aquino, Victor Flores, Carolina N. Martemucci, María Mercedes Vernengo, Silvina María Martinez, Juan Emanuel Segovia, María Gabriela Aguirre
236 [GO] 2020―Nov―24 Correction to: BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial Ana Paula Junqueira-Kipnis, Laura Raniere Borges dos Anjos, Lília Cristina de Souza Barbosa, Adeliane Castro da Costa, Kellen Christina Malheiros Borges, Amanda da Rocha Oliveira Cardoso, Kaio Mota Ribeiro, Sarah Brena Aparecida Rosa, Carine de Castro Souza, Rogério Coutinho das Neves, Guylherme Saraiva, Sueli Meira da Silva, Erika Aparecida Silveira, Marcelo Fouad Rabahi, Marcus Barreto Conte, André Kipnis
237 [GO] 2020―Nov―23 Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial Miguel Á. Ibarra-Estrada, Miguel Marín-Rosales, Roxana García-Salcido, Sara A. Aguirre-Díaz, Alexandra Vargas-Obieta, Quetzalcóatl Chávez-Peña, José A. López-Pulgarín, Julio C. Mijangos-Méndez, Guadalupe Aguirre-Avalos
238 [GO] 2020―Nov―23 Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial Emanuele Bosi, Carlo Bosi, Patrizia Rovere Querini, Nicasio Mancini, Giliola Calori, Annalisa Ruggeri, Cecilia Canzonieri, Luciano Callegaro, Massimo Clementi, Francesco De Cobelli, Massimo Filippi, Marco Bregni
239 [GO] 2020―Nov―23 Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial Hrishikesh Rangnekar, Suresh Patankar, Kishor Suryawanshi, Pravin Soni
240 [GO] 2020―Nov―23 Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction David Lerner, Katherine Garvey, Annie Arrighi-Allisan, Andrey Filimonov, Peter Filip, Katherine Liu, Sen Ninan, Madeleine Schaberg, Patrick Colley, Anthony Del Signore, Satish Govindaraj, Alfred Marc Iloreta
241 [GO] 2020―Nov―23 Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial Timothy O’Shea, Lawrence Mbuagbaw, Vaibhav Mokashi, David Bulir, Jodi Gilchrist, Nicole Smieja, Sylvia Chong, Sarah Marttala, Valentina Vera, Anna Cvetkovic, Marek Smieja
242 [GO] 2020―Nov―19 Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV): A structured summary of a study protocol for a randomised controlled trial Jozefien Declercq, Cedric Bosteels, Karel Van Damme, Elisabeth De Leeuw, Bastiaan Maes, Ans Vandecauter, Stefanie Vermeersch, Anja Delporte, Bénédicte Demeyere, Marnik Vuylsteke, Marianna Lalla, Trevor Smart, Laurent Detalle, René Bouw, Johannes Streffer, Thibo Degeeter, Marie Vergotte, Tanguy Guisez, Eva Van Braeckel, Catherine Van Der Straeten, Bart N. Lambrecht
243 [GO] 2020―Nov―19 Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial Catherine R. Hanna, Kevin G. Blyth, Glenn Burley, Samantha Carmichael, Carol Evans, Samantha Hinsley, Ibrahim Khadra, Saye Khoo, Liz-Anne Lewsley, Robert R. Jones, Raman Sharma, Andrea Taladriz-Sender, Emma C. Thomson, Janet T. Scott
244 [GO] 2020―Nov―17 CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial Andrew Bates, Sophie Rushbrook, Elan Shapiro, Michael Grocott, Rebecca Cusack
245 [GO] 2020―Nov―17 Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
246 [GO] 2020―Nov―11 The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial Ali Dabbagh, Samira Rajaei, Mehdi Ghahremani, Mohammad Fathi, Nilofar Massoudi, Sasan Tavana, Kamal Fani, Navid Nooraee, Nasser Malekpour Alamdari, Sara Besharat, Arash Najafi Abrandabadi, Ali Pirsalehi, Mohammad Ali Khabiri Khatiri
247 [GO] 2020―Nov―11 Cov-hep study: heparin in standard anticoagulation based on citrate for continuous veno-venous hemodialysis in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial Paulo Ricardo Gessolo Lins, Claudia Coimbra César de Albuquerque, Camila Fernandes Assis, Bruna Cristine Duarte Rodrigues, Beatriz Pinto e Siqueira Campos, Eduardo de Oliveira Valle, Carla Paulina Sandoval Cabrera, Jeison de Oliveira Gois, Gabriela Cardoso Segura, Fernando Louzada Strufaldi, Lorena Catelan Mainardes, Rayra Gomes Ribeiro, Daniela Del Pilar Via Reque Cortes, Luciana Gil Lutf, Márcia Fernanda Arantes de Oliveira, Gabriel Teixeira Montezuma Sales, Igor Smolentzov, Bernardo Vergara Reichert, Lucia Andrade, Victor Faria Seabra, Camila Eleuterio Rodrigues
248 [GO] 2020―Nov―02 Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial Shaukat Ali, Shobha Luxmi, Fatima Anjum, Sheikh Muhammad Muhaymin, Syed Muneeb Uddin, Ayesha Ali, Mir Rashid Ali, Sohaib Tauheed, Mujtaba Khan, Mohsin Bajwa, Saif Ullah Baig, Elisha Shalim, Iqra Ahmed, Abdul Samad Khan, Saeed Quraishy
249 [GO] 2020―Nov―02 Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial Florence Carrouel, Stéphane Viennot, Martine Valette, Jean-Marie Cohen, Claude Dussart, Denis Bourgeois
250 [GO] 2020―Oct―31 A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial Mohammad Bosaeed, Ebrahim Mahmoud, Mohammad Hussein, Ahmad Alharbi, Abdulrahman Alsaedy, Adel Alothman, Majed Aljeraisy, Hajar Alqahtani, Marwan Nashabat, Badriah Almutairi, Manar Almaghaslah, Omar Aldibasi, Sameera AlJohani, Abderrezak Bouchama, Yaseen Arabi, Ahmad Alaskar
251 [GO] 2020―Oct―30 Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial Nirmal Ghati, Ambuj Roy, Sushma Bhatnagar, Sumit Bhati, Sudha Bhushan, Manjit Mahendran, Abhishek Thakur, Pawan Tiwari, Tanima Dwivedi, Kalaivani Mani, Ritu Gupta, Anant Mohan, Rakesh Garg, Anita Saxena, Randeep Guleria, Siddharthan Deepti
252 [GO] 2020―Oct―28 Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial Ashkan Emadi, Joel V. Chua, Rohit Talwani, Søren M. Bentzen, John Baddley
253 [GO] 2020―Oct―27 The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli, P. Balaji
254 [GO] 2020―Oct―27 Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial Mehdi Hassaniazad, Ali Bazram, Soheil Hassanipour, Mohammad Fathalipour
255 [GO] 2020―Oct―27 Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial Helda Tutunchi, Majid Mobasseri, Samira Pourmoradian, Hamid Soleimanzadeh, Behnam Kafil, Neda Akbari, Alireza Monshikarimi, Alireza Ostadrahimi
256 [GO] 2020―Oct―26 Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial Fazle Rabbi Chowdhury, Ashraful Hoque, Forhad Uddin Hasan Chowdhury, Md. Ruhul Amin, Abdur Rahim, M. Mujibur Rahman, Rubina Yasmin, Md. Robed Amin, Md. Titu Miah, Md. Abul Kalam, Md. Sayedur Rahman
257 [GO] 2020―Oct―26 An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial Ilad Alavi Darazam, Firouze Hatami, Mohammad Mahdi Rabiei, Mohamad Amin Pourhoseingholi, Omid Moradi, Shervin Shokouhi, Mohammad Reza Hajesmaeili, Minoosh Shabani, Seyed Sina Naghibi Irvani
258 [GO] 2020―Oct―26 Evaluation of the efficacy and safety of Melatonin in moderately ill patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial Ava Ziaei, Parivash Davoodian, Habib Dadvand, Omid Safa, Soheil Hassanipour, Mahmoud Omidi, Moein Masjedi, Fahime Mahmoudikia, Bahareh Rafiee, Mohammad Fathalipour
259 [GO] 2020―Oct―26 BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial Ana Paula Junqueira-Kipnis, Laura Raniere Borges dos Anjos, Lília Cristina de Souza Barbosa, Adeliane Castro da Costa, Kellen Christina Malheiros Borges, Amanda da Rocha Oliveira Cardoso, Kaio Mota Ribeiro, Sarah Brena Aparecida Rosa, Carine de Castro Souza, Rogério Coutinho das Neves, Guylherme Saraiva, Sueli Meira da Silva, Erika Aparecida da Silveira, Marcelo Fouad Rabahi, Marcus Barreto Conte, André Kipnis
260 [GO] 2020―Oct―22 The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial Mehdi Hassaniazad, Behnaz Rahnama Inchehsablagh, Hossein Kamali, Abdolali Tousi, Ebrahim Eftekhar, Mahmoud Reza Jaafari, Mohammad Fathalipour, Sara Nikoofal-Sahlabadi, Hamed Gouklani, Hesam Alizade, Amin Reza Nikpoor
261 [GO] 2020―Oct―22 “Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial” Luciana Teofili, Raffaele Landolfi, Antonella Cingolani, Andrea Antinori, Jacopo Vecchiet, Maurizio Sanguinetti, Antonio Gasbarrini, Tina Pasciuto, Nicoletta Orlando, Silvia Lamonica
262 [GO] 2020―Oct―21 Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial Luisa Weiner, Fabrice Berna, Nathalie Nourry, François Severac, Pierre Vidailhet, Amaury C. Mengin
263 [GO] 2020―Oct―20 Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial Prasan Kumar Panda, Arkapal Bandyopadhyay, Budha Charan Singh, Bikram Moirangthem, Gaurav Chikara, Sarama Saha, Yogesh Arvind Bahurupi
264 [GO] 2020―Oct―20 Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan Pradeesh Sivapalan, Charlotte Suppli Ulrik, Therese Sophie Lappere, Josefin Viktoria Eklöf, Saher Burhan Shaker, Uffe Christian Steinholtz Bødtger, Andrea Browatzki, Christian Niels Meyer, Ulla Møller Weinreich, Christian B. Laursen, Tor Biering-Sørensen, Filip Krag Knop, Jens D. Lundgren, Jens-Ulrik Stæhr Jensen
265 [GO] 2020―Oct―15 Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial Ricardo Palacios, Elizabeth González Patiño, Roberta de Oliveira Piorelli, Monica Tilli Reis Pessoa Conde, Ana Paula Batista, Gang Zeng, Qianqian Xin, Esper G. Kallas, Jorge Flores, Christian F. Ockenhouse, Christopher Gast
266 [GO] 2020―Oct―13 Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial) Alexandre Duvignaud, Edouard Lhomme, Thierry Pistone, Racha Onaisi, Rémi Sitta, Valérie Journot, Duc Nguyen, Nathan Peiffer-Smadja, Antoine Crémer, Stéphane Bouchet, Thomas Darnaud, Delphine Poitrenaud, Lionel Piroth, Christine Binquet, Jean-François Michel, Benjamin Lefèvre, David Lebeaux, Josselin Lebel, Julie Dupouy, Caroline Roussillon, Anne Gimbert, Linda Wittkop, Rodolphe Thiébaut, Joanna Orne-Gliemann, Jean-Philippe Joseph, Laura Richert, Xavier Anglaret, Denis Malvy
267 [GO] 2020―Oct―13 An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial James H. McMahon, Jillian S. Y. Lau, Janine Roney, Benjamin A. Rogers, Jason Trubiano, Joseph Sasadeusz, James S. Molton, Bradley Gardiner, Sue J. Lee, Jennifer F. Hoy, Allen Cheng, Anton Y. Peleg
268 [GO] 2020―Oct―13 The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial Hamid Reza Samimagham, Mehdi Hassani Azad, Maryam Haddad, Mohsen Arabi, Dariush Hooshyar, Mitra KazemiJahromi
269 [GO] 2020―Oct―09 Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial Omid Safa, Mehdi Hassaniazad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour, Mohammad Fathalipour
270 [GO] 2020―Oct―06 A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial Maike Janssen, Ulrike Schäkel, Carine Djuka Fokou, Johannes Krisam, Jacek Stermann, Katharina Kriegsmann, Isabella Haberbosch, Jan Philipp Novotny, Stefan Weber, Maria Vehreschild, Martin Bornhäuser, Lars Bullinger, Michael Schmitt, Tobias Liebregts, Peter Dreger, Hanns-Martin Lorenz, Anna Plaszczyca, Ralf Bartenschlager, Barbara Müller, Hans-Georg Kräusslich, Niels Halama, Dirk Jäger, Richard F. Schlenk, Albrecht Leo, Stefan Meuer, Markus A. Weigand, Johann Motsch, Uta Merle, Claudia M. Denkinger, Carsten Müller-Tidow
271 [GO] 2020―Oct―02 A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial Shin Takayama, Takao Namiki, Takashi Ito, Ryutaro Arita, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Mosaburo Kainuma, Kotaro Nochioka, Airi Takagi, Masaru Mimura, Takuhiro Yamaguchi, Tadashi Ishii
272 [GO] 2020―Sep―29 Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial Bálint Erőss, Zsolt Molnár, Zsolt Szakács, Noémi Zádori, Lajos Szakó, Szilárd Váncsa, Márk Félix Juhász, Klementina Ocskay, Nóra Vörhendi, Katalin Márta, Andrea Szentesi, Andrea Párniczky, Péter J. Hegyi, Szabolcs Kiss, Mária Földi, Fanni Dembrovszky, Anna Kanjo, Piroska Pázmány, András Varró, Árpád Csathó, Zsuzsanna Helyes, Zoltán Péterfi, László Czopf, István Kiss, Antal Zemplényi, Dóra Czapári, Eszter Hegyi, Dalma Dobszai, Emőke Miklós, Attila Márta, Dominika Tóth, Richard Farkas, Nelli Farkas, Béla Birkás, Erika Pintér, Gábor Pethő, Borbála Zsigmond, Andrea Sárközi, Anikó Nagy, Péter Hegyi
273 [GO] 2020―Sep―29 Moving fast but going slow: coordination challenges for trials of COVID-19 post-exposure prophylaxis Darrell H. S. Tan, Rupesh Agrawal, Ruanne V. Barnabas, Jon T. Giles, Peter Dull
274 [GO] 2020―Sep―17 Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark Anne Marie Rosendahl Madsen, Frederik Schaltz-Buchholzer, Thomas Benfield, Morten Bjerregaard-Andersen, Lars Skov Dalgaard, Christine Dam, Sisse Bolm Ditlev, Gulia Faizi, Isik Somuncu Johansen, Poul-Erik Kofoed, Gitte Schultz Kristensen, Ellen Christine Leth Loekkegaard, Christian Backer Mogensen, Libin Mohamed, Anne Ostenfeld, Emilie Sundhaugen Oedegaard, Marcus Kjaer Soerensen, Christian Wejse, Aksel Karl Georg Jensen, Sebastian Nielsen, Tyra Grove Krause, Mihai G. Netea, Peter Aaby, Christine Stabell Benn
275 [GO] 2020―Sep―16 Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial Antonio F. Caballero Bermejo, Belén Ruiz-Antorán, Ana Fernández Cruz, Elena Diago Sempere, Alejandro Callejas Díaz, Elena Múñez Rubio, Cristina Avendaño-Solá, Antonio Ramos Martínez, Aránzazu Sancho López
276 [GO] 2020―Sep―15 Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial Omid Safa, Mehdi Hassani-Azad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour, Mohammad Fathalipour
277 [GO] 2020―Sep―14 A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial Farhan Raza Khan, Syed Murtaza Raza Kazmi, Najeeha Talat Iqbal, Junaid Iqbal, Syed Tariq Ali, Syed Akbar Abbas
278 [GO] 2020―Sep―11 It is unprecedented: trial management during the COVID-19 pandemic and beyond Eleanor J. Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield, Alison McDonald
279 [GO] 2020―Sep―11 Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial Stefan Roehrig, Ali Ait Hssain, Nabil Al Hamid Shallik, Ingi Mohamed A. Elsaid, Salma Faisal Mustafa, Osama A. M. Smain, Ashraf Abdulla Molokhia, Marcus D. Lance
280 [GO] 2020―Sep―10 Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial Rosario Garcia-Vicuña, Francisco Abad-Santos, Isidoro González-Alvaro, Francisco Ramos-Lima, Jesús Sanz Sanz
281 [GO] 2020―Sep―10 Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial Stefano Barco, Roland Bingisser, Giuseppe Colucci, André Frenk, Bernhard Gerber, Ulrike Held, Francois Mach, Lucia Mazzolai, Marc Righini, Thomas Rosemann, Tim Sebastian, Rebecca Spescha, Stefan Stortecky, Stephan Windecker, Nils Kucher
282 [GO] 2020―Sep―07 Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial Nadir Kharma, Stefan Roehrig, Ahmed Atef Shible, Moustafa Sayed Elshafei, Dema Osman, Ingi Mohamed Elsaid, Salma Faisal Mustafa, Asjad Aldabi, Osamah A.M. Smain, Marcus D. Lance
283 [GO] 2020―Sep―03 The COVIRL002 Trial-Tocilizumab for management of severe, non-critical COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial Aoife Cotter, Deborah Wallace, Cormac McCarthy, Eoin Feeney, Lorraine O’Neill, John Stack, Geraldine McCarthy, Rabia Hussain, Elena Alvarez Barco, Peter Doran, Patrick Mallon
284 [GO] 2020―Aug―31 Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Oommen John, Arpita Ghosh, Abhinav Bassi, Sumaiya Arfin, Mallikarjuna Kunigari, Rohina Joshi, Lachlan Donaldson, Naomi Hammond, Balasubramanian Venkatesh
285 [GO] 2020―Aug―27 Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial Shuaipan Zhang, Qingguang Zhu, Chao Zhan, Wei Cheng, Xiao Mingfang, Min Fang, Lei Fang
286 [GO] 2020―Aug―27 Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial Madunil A. Niriella, Dileepa S. Ediriweera, Arjuna P. De Silva, Ranjan Premarathne, Priyantha Balasooriya, Kaluthanthri D. Duminda, Neelika G. Malavige, Kamani Wanigasuriya, Sarath Lekamwasam, Senanayake A. Kularathne, Sisira Siribaddana, Hithanadura J. de Silva, Saroj Jayasinghe
287 [GO] 2020―Aug―26 High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial Luis Patricio Maskin, Gabriel Leonardo Olarte, Fernando Palizas, Agostina E. Velo, María Fernanda Lurbet, Ignacio Bonelli, Natalio D. Baredes, Pablo Oscar Rodríguez
288 [GO] 2020―Aug―26 The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial Pär Ingemar Johansson, Morten Bestle, Peter Søe-Jensen, Klaus Tjelle Kristiansen, Jakob Stensballe, Niels Erikstrup Clausen, Anders Perner
289 [GO] 2020―Aug―24 Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trial Zong-Yu Wang, Shou-Zhi Fu, Liang Xu, Shu-Sheng Li, Ke-Jian Qian, Xian-Di He, Guo-Chao Zhu, Liang-Hai Li, Jun Zhang, Wen-Fang Li, Bing-Yu Qin, Chen-Liang Zhou, Peng-Lin Ma
290 [GO] 2020―Aug―24 Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials Jonathan A. C. Sterne, Janet Diaz, Jesús Villar, Srinivas Murthy, Arthur S. Slutsky, Anders Perner, Peter Jüni, Derek C. Angus, Djillali Annane, Luciano Cesar Pontes Azevedo, Bin Du, Pierre-Francois Dequin, Anthony C. Gordon, Cameron Green, Julian P. T. Higgins, Peter Horby, Martin J. Landray, Giuseppe Lapadula, Amelie Le Gouge, Marie Leclerc, Jelena Savović, Bruno Tomazini, Balasubramanian Venkatesh, Steve Webb, John C. Marshall
291 [GO] 2020―Aug―22 Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
292 [GO] 2020―Aug―17 A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial Timothy S. C. Hinks, Vicki S. Barber, Joanna Black, Susan J. Dutton, Maisha Jabeen, James Melhorn, Najib M Rahman, Duncan Richards, Daniel Lasserson, Ian D. Pavord, Mona Bafadhel
293 [GO] 2020―Aug―17 Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial Stefano Busani, Martina Tosi, Pasquale Mighali, Paola Vandelli, Roberto D’Amico, Marco Marietta, Francesco Forfori, Abele Donati, Gilda Cinnella, Amato De Monte, Daniela Pasero, Giacomo Bellani, Carlo Tascini, Giuseppe Foti, Marco Ranieri, Massimo Girardis
294 [GO] 2020―Aug―16 Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial Jesús Villar, José M. Añón, Carlos Ferrando, Gerardo Aguilar, Tomás Muñoz, José Ferreres, Alfonso Ambrós, César Aldecoa, Fernando Suárez-Sipmann, Kevin E. Thorpe, Peter Jüni, Arthur S. Slutsky
295 [GO] 2020―Aug―08 Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial Greg J. Elder, Pamela Alfonso-Miller, William C. M. Atkinson, Nayantara Santhi, Jason G. Ellis
296 [GO] 2020―Aug―08 Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
297 [GO] 2020―Aug―08 Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki, Tariq A. Madani
298 [GO] 2020―Aug―05 A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial Miguel Rodríguez-Rubio, Juan Carlos Figueira, Darío Acuña-Castroviejo, Alberto M. Borobia, Germaine Escames, Pedro de la Oliva
299 [GO] 2020―Jul―31 PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial Oriana Nanni, Pierluigi Viale, Bernadette Vertogen, Claudia Lilli, Chiara Zingaretti, Caterina Donati, Carla Masini, Manuela Monti, Patrizia Serra, Roberto Vespignani, Veruska Grossi, Annibale Biggeri, Emanuela Scarpi, Francesca Galardi, Lucia Bertoni, Americo Colamartini, Fabio Falcini, Mattia Altini, Ilaria Massa, Raffaella Gaggeri, Giovanni Martinelli
300 [GO] 2020―Jul―31 ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial Tom Wilkinson, Rupert Dixon, Clive Page, Miles Carroll, Gareth Griffiths, Ling-Pei Ho, Anthony De Soyza, Timothy Felton, Keir E. Lewis, Karen Phekoo, James D. Chalmers, Anthony Gordon, Lorcan McGarvey, Jillian Doherty, Robert C. Read, Manu Shankar-Hari, Nuria Martinez-Alier, Michael O’Kelly, Graeme Duncan, Roelize Walles, James Sykes, Charlotte Summers, Dave Singh
301 [GO] 2020―Jul―31 muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial Ing Ni Lu, Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Sonakshi Kadyan, Simon Bond, Sam Norton, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson, Joseph Cheriyan
302 [GO] 2020―Jul―29 Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial Berta Grau-Pujol, Daniel Camprubí, Helena Marti-Soler, Marc Fernández-Pardos, Caterina Guinovart, Jose Muñoz
303 [GO] 2020―Jul―29 RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial Gavin D. Perkins, Keith Couper, Bronwen Connolly, J. Kenneth Baillie, Judy M. Bradley, Paul Dark, Anthony De Soyza, Ellen Gorman, Alasdair Gray, Louisa Hamilton, Nicholas Hart, Chen Ji, Ranjit Lall, Nicola McGowan, Scott Regan, Anita K. Simonds, Emma Skilton, Nigel Stallard, Emily Stimpson, Joyce Yeung, Daniel F. McAuley
304 [GO] 2020―Jul―20 Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial Mary Daval, Alain Corré, Clement Palpacuer, Juliette Housset, Guillaume Poillon, Michael Eliezer, Benjamin Verillaud, Dorsaf Slama, Denis Ayache, Philippe Herman, Clement Jourdaine, Camille Hervé, Wissame El Bakkouri, Dominique Salmon, Charlotte Hautefort
305 [GO] 2020―Jul―14 Correction to: ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan
306 [GO] 2020―Jul―14 Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial Ka Sing Paris Lai, Christine Watt, Emily Ionson, Imants Baruss, Cheryl Forchuk, Javeed Sukhera, Amer M. Burhan, Akshya Vasudev
307 [GO] 2020―Jul―14 The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial Justin T. Denholm, Joshua Davis, David Paterson, Jason Roberts, Susan Morpeth, Thomas Snelling, Dominica Zentner, Megan Rees, Matthew O’Sullivan, David Price, Asha Bowen, Steven Y. C. Tong
308 [GO] 2020―Jul―14 Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada Julie K. Wright, Darrell H. S. Tan, Sharon L. Walmsley, Jennifer Hulme, Erin O’Connor, Carolyn Snider, Ivy Cheng, Adrienne K. Chan, Bjug Borgundvaag, Shelley McLeod, Michael H. Gollob, Rosemarie J. Clarke, Linda Dresser, Fatima Haji, Tony Mazzulli, Samira Mubareka, Peter Jüni, Dominic Lee, George Tomlinson, Kevin C. Kain, Megan Landes
309 [GO] 2020―Jul―13 A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial Keisha Smith, Amy Pace, Stephan Ortiz, Shamsah Kazani, Scott Rottinghaus
310 [GO] 2020―Jul―09 Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial Miriam Saiz-Rodríguez, Teresa Peña, Lourdes Lázaro, Ángel González, Andrés Martínez, José A. Cordero, Juan T. Vicente, Fernando Richard, María Jesús Coma, Martín de Frutos, Jorge Labrador, Ana Pueyo
311 [GO] 2020―Jul―08 Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 - Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Simon Bond, Elena Hernan-Sancho, Sam Norton, Joseph Cheriyan, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson
312 [GO] 2020―Jul―08 Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)-protocol of randomised controlled trial AZIQUINE-ICU František Duška, Petr Waldauf, Milada Halačová, Václav Zvoníček, Jakub Bala, Martin Balík, Jan Beneš, Olga Klementová, Irena Kozáková, Viktor Kubricht, Anne Le Roy, Tomáš Vymazal, Veronika Řehořová, Vladimír Černý
313 [GO] 2020―Jul―08 Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study Xi Liu, Huili Chen, Yuqi Shang, Hongqiong Zhu, Gongqi Chen, Yuanli Chen, Shaoxuan Liu, Yaoyong Zhou, Mingxing Huang, Zhongsi Hong, Jinyu Xia
314 [GO] 2020―Jul―06 Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh, Maedeh Mahmoodi Ali Abadi, Morteza Foroumandi
315 [GO] 2020―Jul―03 Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial Atsushi Kawaguchi, Gabrielle Bernier, Jacques Lacroix, Saly El Salti, Matthew P. Cheng, Todd C. Lee, Kosar Khwaja, Philippe Jouvet
316 [GO] 2020―Jul―03 The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial Mohammad Nasb, Zulfiqar Ali Sayed Shah, Liangjiang Huang, Qian Li, Hong Chen
317 [GO] 2020―Jul―02 Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez
318 [GO] 2020―Jul―02 ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Evangelia Vamvaka, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan
319 [GO] 2020―Jun―29 Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19): A structured summary of a study protocol for a randomised controlled trial Felicitas Stoll, Antje Blank, Gerd Mikus, David Czock, Kathrin I. Foerster, Simon Hermann, Katja Häußler, Amin Muhareb, Simone Hummler, Johanna Weiss, Jürgen Burhenne, Walter E. Haefeli
320 [GO] 2020―Jun―29 Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial Juan Jose Gonzalez-Gerez, Carlos Bernal-Utrera, Ernesto Anarte-Lazo, Jose Antonio Garcia-Vidal, Jose Martin Botella-Rico, Cleofas Rodriguez-Blanco
321 [GO] 2020―Jun―26 CytoResc - “CytoSorb” Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial Helena Stockmann, Theresa Keller, Stefan Büttner, Achim Jörres, Detlef Kindgen-Milles, Julius Valentin Kunz, Josef Leebmann, Claudia Spies, Karl Träger, Sascha Treskatsch, Alexander Uhrig, Carsten Willam, Philipp Enghard, Torsten Slowinski
322 [GO] 2020―Jun―26 Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol Marco Marietta, Paola Vandelli, Pasquale Mighali, Roberto Vicini, Valeria Coluccio, Roberto D’Amico
323 [GO] 2020―Jun―26 Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial Constantinos Pantos, Georgia Kostopanagiotou, Apostolos Armaganidis, Athanasios Trikas, Ioulia Tseti, Iordanis Mourouzis
324 [GO] 2020―Jun―26 Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial Abolghasem Allahyari, Hossein Rahimi, Majid Khadem-Rezaiyan, Zahra Mozaheb, Mohsen Seddigh-Shamsi, Alireza Bary, Mostafa Kamandi, Sajad Ataei Azimi, Saeed Eslami HasanAbadi, Alireza Noferesti, Somayeh Sadat Shariatmaghani, Houshang Rafatpanah, Shohreh Khatami, Afshin Jabbar Imani, Hassan Mortazi, Mohammad Moeini Nodeh
325 [GO] 2020―Jun―26 A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial” Carlos Tornero, Ricardo Vallejo, David Cedeño, Jorge Orduña, Ernesto Pastor, Moncef Belaouchi, Benigno Escamilla, Marisa Laredo, María del Mar Garzando
326 [GO] 2020―Jun―24 Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial Bangjiang Fang, Wen Zhang, Xinxin Wu, Tingrong Huang, Huacheng Li, You Zheng, Jinhua Che, Shuting Sun, Chao Jiang, Shuang Zhou, Jun Feng
327 [GO] 2020―Jun―22 Correction to: Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea
328 [GO] 2020―Jun―22 Correction to: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht
329 [GO] 2020―Jun―22 Correction to: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht
330 [GO] 2020―Jun―19 Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial Nafiseh Abdolahi, Effat Kaheh, Roghieh Golsha, Behnaz Khodabakhshi, Alireza Norouzi, Mahmoud Khandashpoor, Sima Besharat, Samane Tavassoli, Somayeh Livani, Sadegh Ali Azimi, Mohammad Hadi Gharib, Babak Peivandi, Abdolreza Fazel, Hesamaddin Shirzad-Aski, Gholamreza Roshandel
331 [GO] 2020―Jun―19 AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial Gareth Griffiths, Richard Fitzgerald, Thomas Jaki, Andrea Corkhill, Ellice Marwood, Helen Reynolds, Louise Stanton, Sean Ewings, Susannah Condie, Emma Wrixon, Andrea Norton, Mike Radford, Sara Yeats, Jane Robertson, Rachel Darby-Dowman, Lauren Walker, Saye Khoo
332 [GO] 2020―Jun―19 Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial J. P. Desilles, C. Gregoire, C. Le Cossec, J. Lambert, O. Mophawe, M. R. Losser, F. Lambiotte, S. Le Tacon, M. Cantier, N. Engrand, P. Trouiller, J. Pottecher
333 [GO] 2020―Jun―16 Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
334 [GO] 2020―Jun―12 Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II) Qingsong Ye, Hua Wang, Xia Xia, Chenliang Zhou, Zhiming Liu, Zun-en Xia, Zhan Zhang, Yang Zhao, Jun Yehenala, Si Wang, Gangqiao Zhou, Ke Hu, Bin Wu, Chu-Tse Wu, Songling Wang, Yan He
335 [GO] 2020―Jun―10 Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial Pradeesh Sivapalan, Charlotte Suppli Ulrik, Rasmus Dahlin Bojesen, Therese Sophie Lapperre, Josefin Viktoria Eklöf, Kjell Erik Julius Håkansson, Andrea Browatzki, Casper Tidemansen, Jon Torgny Wilcke, Julie Janner, Vibeke Gottlieb, Howraman Meteran, Celeste Porsbjerg, Birgitte Lindegaard Madsen, Mia Moberg, Lars Pedersen, Thomas Lars Benfield, Jens Dilling Lundgren, Filip Krag Knop, Tor Biering-Sørensen, Muzhda Ghanizada, Tine Peick Sonne, Uffe Christian Steinholtz Bødtger, Sidse Graff Jensen, Daniel Bech Rasmussen, Eva Brøndum, Oliver Djurhuus Tupper, Susanne Wiemann Sørensen, Gitte Alstrup, Christian Borbjerg Laursen, Ulla Weinrich Møller, Asger Sverrild, Jens-Ulrik Stæhr Jensen
336 [GO] 2020―Jun―08 A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol Fahad Faqihi, Abdulrahman Alharthy, Mohammed Alodat, Daood Asad, Waleed Aletreby, Demetrios J. Kutsogiannis, Peter G. Brindley, Dimitrios Karakitsos
337 [GO] 2020―Jun―08 The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial Carlos Chaccour, Paula Ruiz-Castillo, Mary-Ann Richardson, Gemma Moncunill, Aina Casellas, Francisco Carmona-Torre, Miriam Giráldez, Juana Schwartz Mota, José Ramón Yuste, José Ramón Azanza, Miriam Fernández, Gabriel Reina, Carlota Dobaño, Joe Brew, Belen Sadaba, Felix Hammann, Regina Rabinovich
338 [GO] 2020―Jun―08 Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial José Meneses Calderón, Hugo Mendieta Zerón, Srivatsan Padmanabhan
339 [GO] 2020―Jun―08 Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberg, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
340 [GO] 2020―Jun―08 Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial Chi Zhang, Jiawen Li, Zhao Wu, He Wang, Chengli Que, Hong Zhao, Guiqiang Wang
341 [GO] 2020―Jun―05 Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea
342 [GO] 2020―Jun―05 Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie, Somayeh Fatemizadeh
343 [GO] 2020―Jun―05 Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø, Olav Dalgard
344 [GO] 2020―Jun―05 Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht
345 [GO] 2020―Jun―03 Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial Ruanne V. Barnabas, Elizabeth Brown, Anna Bershteyn, R. Scott Miller, Mark Wener, Connie Celum, Anna Wald, Helen Chu, David Wesche, Jared M. Baeten
346 [GO] 2020―Jun―03 A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial Alain Vandormael, Maya Adam, Merlin Greuel, Till Bärnighausen
347 [GO] 2020―Jun―03 Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht
348 [GO] 2020―Jun―03 A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial Jonathan Rilinger, Winfried V. Kern, Daniel Duerschmied, Alexander Supady, Christoph Bode, Dawid L. Staudacher, Tobias Wengenmayer
349 [GO] 2020―Jun―03 Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams, Gerard Curley, John G. Laffey, Mike Clarke, Cecilia O’Kane, Daniel F. McAuley
350 [GO] 2020―Jun―03 Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial Atul Malhotra, David Ernest, Benjamin A. Rogers, David Haylock, Ashalyn Watt, Guy Moeneclaey, Graham Jenkin
351 [GO] 2020―Jun―03 Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial Reihaneh Pirjani, Tahereh Soori, Ahmad Reza Dehpour, Mahdi Sepidarkish, Ashraf Moini, Arshia Shizarpour, Razieh Mohammad Jafari
352 [GO] 2020―Jun―03 Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial Seyed Sina Naghibi Irvani, Maryam Golmohammadi, Mohamad Amin Pourhoseingholi, Shervin Shokouhi, Ilad Alavi Darazam
353 [GO] 2020―Jun―03 A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial Irene García García, Miguel Rodriguez-Rubio, Amelia Rodríguez Mariblanca, Lucía Martínez de Soto, Lucía Díaz García, Jaime Monserrat Villatoro, Javier Queiruga Parada, Enrique Seco Meseguer, María J. Rosales, Juan González, José R. Arribas, Antonio J. Carcas, Pedro de la Oliva, Alberto M. Borobia
354 [GO] 2020―May―25 The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial Eoin Feeney, Deborah Wallace, Aoife Cotter, Willard Tinago, Cormac McCarthy, David Keane, Rabia Hussain, Elena Alvarez Barco, Peter Doran, Patrick Mallon
355 [GO] 2020―May―24 Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial Yeming Wang, Fei Zhou, Dingyu Zhang, Jianping Zhao, Ronghui Du, Yi Hu, Zhenshun Cheng, Ling Gao, Yang Jin, Guangwei Luo, Shouzhi Fu, Qiaofa Lu, Guanhua Du, Ke Wang, Yang Lu, Guohui Fan, Yi Zhang, Ying Liu, Shunan Ruan, Wen Liu, Thomas Jaki, Frederick G. Hayden, Peter W. Horby, Bin Cao, Chen Wang
356 [GO] 2020―May―23 Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial Shuaipan Zhang, Zhizhen Lv, Qingguang Zhu, Wuquan Sun, Fei Yao, Lei Fang, Yanbin Cheng, Zhiwei Wu, Min Fang
357 [GO] 2020―May―13 An online solution focused brief therapy for adolescent anxiety during the novel coronavirus disease (COVID-19) pandemic: a structured summary of a study protocol for a randomised controlled trial Shitao Chen
358 [GO] 2020―Jan―03 Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Al Mekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Abdullah Almotairi, Ali Al Bshabshe, Ayman Kharaba, Jesna Jose, Abdulrahman Al Harthy, Mohammed Al Sulaiman, Ahmed Mady, Robert A. Fowler, Frederick G. Hayden, Abdulaziz Al-Dawood, Mohamed Abdelzaher, Wail Bajhmom, Mohamed A. Hussein
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