909REM
Research type
Research Study
Full title
A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults with COVID-19 who have been treated with Remdesivir.
IRAS ID
293273
Contact name
Anton Pozniak
Contact email
Sponsor organisation
NEAT ID Foundation
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This is a multi-centre, multi-country retrospective cohort study that will evaluate the clinical outcomes in adults with COVID-19 who have been treated with Remdesivir. This will be assessed by a 7-point ordinal scale on Day 14 and all-cause mortality at Day 28. At least 450 COVID-19 cases, from up to 20 participating study sites, who meet all eligibility criteria will be included in the analysis. Part 2, which is collecting data on non- RDV treated controls, will only be initiated, if required, and once data from Part 1, the cases, is collected and analysed. Matching criteria will be detailed in a study management document. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries and then entered into a structured e-CRF system. In addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0046
Date of REC Opinion
5 Mar 2021
REC opinion
Further Information Favourable Opinion