5773 Safety and Antiviral Activity of Remdesivir for severe 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 Severe COVID-19
IRAS ID
282007
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2020-000841-15
ISRCTN Number
ISRCTN15874265
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 how effective two different treatment plans of remdesivir are in returning body temperature and oxygen levels back to normal over a 14 day period in patients with severe COVID-19. Approximately 6000 patients will participate worldwide with up to 400 patients from 15 hospitals in the UK. The first part of the study will include 400 patients with severe COVID-19 who are not mechanically ventilated. 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. The second part of the study will include a total of 5600 patients (some of whom were included in the first part of the study) and will include some patients who are mechanically ventilated. Patients newly enrolled to this 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 patients 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/0104
Date of REC Opinion
25 Mar 2020
REC opinion
Favourable Opinion