Study of Remdesivir in COVID-19 Patients with Reduced Kidney Function [COVID-19]
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19
IRAS ID
293797
Contact name
Kieran McCafferty
Contact email
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2020-005416-22
Clinicaltrials.gov Identifier
IND Number, 147753
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Summary of Research
At the end of 2019, a new virus called severe acute respiratory syndrome coronavirus-2 (SARS CoV 2) began to spread around the world. This virus causes coronavirus disease 2019, or COVID-19. As of 02-Dec-2020 more than 63 million cases had been identified globally of which 1.4 million patients have died. COVID-19 is a major health emergency.
The Sponsor of this study, Gilead Sciences, Inc., has been working with global health authorities to respond to the ongoing pandemic and to evaluate the antiviral drug remdesivir (RDV; GS-5734™) as a treatment option for COVID-19 through clinical trials. Intravenous (IV) RDV was subsequently approved for the treatment of COVID-19 in the EU / UK however it is currently not recommended in people with severely reduced kidney function leaving no alternative treatment options for those with COVID-19.
The purpose of this double-blind study is to evaluate whether treatment with IV RDV reduces the risk of death or invasive mechanical ventilation (IMV) in participants aged at least 12 years old with severely reduced kidney function who are hospitalised for COVID-19.
Participants who meet all eligibility criteria will be randomised in a 2:1 ratio to RDV or placebo:
• Treatment Group A: IV RDV 200 mg on Day 1 followed by IV RDV 100 mg once daily from Day 2 up to Day 5
• Treatment Group B: IV saline as placebo on Days 1 to 5The study consists of screening assessments, a 5-day treatment period, and daily follow-up / assessments from Day 6 to Day 29 as well as a phone follow-up on Day 60. Assessments include physical examinations, vital signs, respiratory status, blood tests and SARS-CoV-2 testing.
Approximately 1,116 participants will participate worldwide with approximately 80 patients from 5 hospitals in the UK.
Summary of Results
The conclusions from Study GS-US-540-5912 are as follows:
a) All-cause death or IMV by Day 29 was reported for 48 of 163 participants (29.4%) in the RDV IV group and 26 of 80 participants (32.5%) in the placebo IV group and the results were not significantly different (P = 0.6132).
b) There were no statistically significant differences between the RDV IV group compared with placebo IV group in all-cause death by Day 29, initiation of IMV by Day 29, time to recovery by Day 29, analysis of clinical status as assessed by an 8-point ordinal scale on Day 15 and Day 29, number of RRT-free days at Day 29 for participants without ESKD at baseline, and proportion of participants with recovery by Day 29.
c) Remdesivir administered for 5 days was generally safe and well tolerated, with a safety profile similar to that of placebo in participants with severely reduced kidney function who were hospitalized for COVID-19.REC name
South Central - Oxford B Research Ethics Committee
REC reference
21/SC/0084
Date of REC Opinion
21 Apr 2021
REC opinion
Further Information Favourable Opinion