Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 28, 2020
Date Accepted: Oct 20, 2020
Date Submitted to PubMed: Nov 18, 2020
The RACCO Trial to Assess the Efficacy and Safety of Inhaled Ciclesonide for Asymptomatic and Mild Patients with Covid-19: A Study Protocol for a Multi-center, Open- labeled, Randomized Controlled Trial
ABSTRACT
Background:
There is currently no specific effective treatment for SARS-CoV-2, but various options to treat COVID-19 are under investigation. It is vital to continue investigating the landscape of SARS-CoV-2-induced pneumonia and therapeutic interventions.
Objective:
This paper presents the protocol for a study that aims to compare the pneumonia exacerbation percentage between Alvesco (Ciclesonide) administration and symptomatic treatment in COVID-19 patients and analyze the efficacy of Alvesco. The secondary objectives include investigating the safety of Alvesco administration, changes in clinical and laboratory findings, and the number of viral genome copies of SARS-CoV-2 over time between the two groups.
Methods:
In this investigator-initiated, exploratory, prospective, multi-center, parallel-group, open-labelled, randomized, trial, a total of 90 patients diagnosed with COVID-19 with specific inclusion/exclusion criteria are recruited from 21 hospitals in Japan. Participants are randomized to either the Alvesco group receiving an Alvesco 400 µg dose three times a day over a seven-day period, or to the symptomatic treatment group. Both groups receive antitussives and antipyretics as required. Data collection for various parameters are conducted on days 1, 2, 4, 8, 22, and 29 to record baseline assessments and the findings over an extended period. CT image scans prior to drug administration and one week following treatment are compared, and efficacy is confirmed by checking for exacerbation of pneumonia. Primary endpoint analysis is performed using Fisher’s exact test to determine statistically significant differences in pneumonia exacerbation percentage between Alvesco and symptomatic treatment groups.
Results:
The first trial participant was enrolled on 3 April 2020; recruitment is expected to be completed on 30 September 2020, with follow-up assessments of all participants expected to be completed by 31 October 2020. Study results will be published in a peer-reviewed scientific journal.
Conclusions:
The RACCO study will provide definitive comparative effectiveness data and important clinical outcomes between the Alvesco and symptomatic treatment groups. If the hypotheses that reduction in pneumonia exacerbation is more superior in the Alvesco treatment group than in the symptomatic treatment group and that Alvesco is safe to use are valid, Alvesco will serve as an important therapeutic option for COVID-19 patients. Clinical Trial: Japan Registry of Clinical Trials NCT No jRCTs031190269
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