5774 Safety & Antiviral Activity of Remdesivir for moderate COVID-19 [COVID-19] [UPH]
Research type
Research Study
Full title
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment
IRAS ID
282026
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2020-000842-32
ISRCTN Number
ISRCTN85762140
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 147753
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
A number of antiviral drugs are being tested as potential treatments for COVID-19 infection including the antiviral drug remdesivir. The purpose of this study is to compare the safety and effectiveness of two different treatment plans of remdesivir with the normal hospital treatment in patients with moderate COVID-19. Approximately 1600 patients will participate worldwide with up to 100 patients from 15 hospitals in the UK. The first part of the study will include 600 patients with moderate COVID-19. They will receive one of the following on a random basis: 1) 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-5 plus the usual standard hospital care; 2) 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-10 plus the usual standard hospital care; 3) the usual standard hospital care. The second part of the study will include a total of 1,000 patients with moderate COVID-19 (some of whom were included in the first part of the study). Patients newly enrolled to this part of the study and those who received only the usual standard hospital care in the first part of the study will all receive 200mg Intravenous remdesivir on Day 1 followed by 100mg on Days 2-10 plus the usual standard hospital care. Patient information including breathing status will be recorded daily for 14 days or until they leave hospital and will be reviewed again after 28 days. The study is paid for by Gilead Sciences, Inc.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0105
Date of REC Opinion
25 Mar 2020
REC opinion
Favourable Opinion