Prevention of Neurological Complications During COVID-19: Protocol for a Retrospective Analysis of the ISARIC4C National Cohort

20 Pages Posted: 24 Feb 2022

See all articles by Alexander Grundmann

Alexander Grundmann

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK

Marc Hardwick

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK

Chieh-Hsi Wu

University of Southampton; Southampton Statistical Sciences Research Institute

Malcolm G. Semple

University of Liverpool - NIHR Health Protection Research Unit for Emerging and Zoonotic Infection

Dankmar Böhning

Statistics, Mathematical Sciences, Faculty of Social Sciences, University of Southampton, UK

Sarah Pett

University College London - MRC Clinical Trials Unit

Benedict Daniel Michael

University of Liverpool - Department of Clinical Infection, Microbiology and Immunology

Rhys H. Thomas

Newcastle University

Ian Galea

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK; Department of Neurology, Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, UK

Date Written: February 17, 2022

Abstract

Neurological complications such as stroke and encephalopathies affect 4% of adults with acute COVID-19 infection, causing significant morbidity with long term health and economic consequences. Dexamethasone reduces the 28-day mortality in hospitalised patients requiring supplemental oxygen, while remdesivir has antiviral action against SARS-CoV-2 and reduces the severity of COVID-19 in these patients. We hypothesise that adding either remdesivir, dexamethasone or both to standard of care in patients hospitalised with COVID-19 may reduce the incidence of COVID-19-associated neurological complications. This retrospective analysis of the ISARIC4C cohort will analyse data from patients aged 18 years and older admitted to hospital with COVID-19 between 31 Jan 2020 and 29 Jun 2021. The incidence of neurological complications following COVID-19 in patients receiving standard of care and either remdesivir, dexamethasone or both will be compared against the standard of care using propensity scoring methodology. The effect of neurological complications on markers of disease severity, as well as clinical outcome, will be assessed using multivariable linear and logistic regression.

Note:
Funding: Gilead, the manufacturer of remdesivir has provided funding to IG to support this analysis.

Declaration of Interests: None of the authors have any conflicts of interest to declare in relation to this study.

Ethics Approval Statement: Only patients who provided biological samples were required to provide informed, written consent. All other patients had routinely collected clinical data collated for which written consent was not required under UK health research regulations. ISARIC WHO CCP-UK received ethical approval from the South Central—Oxford C Research Ethics Committee in England (13/SC/0149) and by the Scotland A Research Ethics Committee in Scotland (20/SS/0028).

Keywords: COVID-19, neurological complications, dexamethasone, remdesivir

Suggested Citation

Grundmann, Alexander and Hardwick, Marc and Wu, Chieh-Hsi and Semple, Malcolm G. and Böhning, Dankmar and Pett, Sarah and Michael, Benedict Daniel and Thomas, Rhys H. and Galea, Ian, Prevention of Neurological Complications During COVID-19: Protocol for a Retrospective Analysis of the ISARIC4C National Cohort (February 17, 2022). Available at SSRN: https://ssrn.com/abstract=4037376 or http://dx.doi.org/10.2139/ssrn.4037376

Alexander Grundmann

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Marc Hardwick

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Chieh-Hsi Wu

University of Southampton ( email )

Mathematical Sciences
Building 54, 58 Salisbury Rd
Southampton SO17 1BJ, SO17 1LP
United Kingdom

Southampton Statistical Sciences Research Institute ( email )

Southampton SO17 1BJ
United Kingdom

Malcolm G. Semple

University of Liverpool - NIHR Health Protection Research Unit for Emerging and Zoonotic Infection

Dankmar Böhning

Statistics, Mathematical Sciences, Faculty of Social Sciences, University of Southampton, UK ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Sarah Pett

University College London - MRC Clinical Trials Unit ( email )

Benedict Daniel Michael

University of Liverpool - Department of Clinical Infection, Microbiology and Immunology

Chatham Street
Brownlow Hill
Liverpool, L69 7ZA
United Kingdom

Rhys H. Thomas

Newcastle University ( email )

Newcastle upon Tyne
NE1 7RU
United Kingdom

Ian Galea (Contact Author)

Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, UK ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

Department of Neurology, Wessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, UK ( email )

University Rd.
Southampton SO17 1BJ, Hampshire SO17 1LP
United Kingdom

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