GS-US-540-9012 COVID-19 Remdesivir Outpatient Study
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of COVID-19 in an Outpatient Setting
IRAS ID
287807
Contact name
Michael Brown
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2020-003510-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
Summary of Research
Severe acute respiratory syndrome (SARS)-coronavirus-2, a single-stranded RNA virus, is identified as the cause of an outbreak of respiratory illness that was first detected in Wuhan, China in December 2019. The virus has now spread globally, resulting in a global pandemic and causing severe respiratory illness throughout the world.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.
The safety and efficacy of RDV has been demonstrated in clinical studies of patients hospitalised with COVID-19. There is currently no approved treatment for patients with COVID-19 who have not been hospitalised. Treatment intervention in the earlier phase of COVID-19, such as in an outpatient setting, may prevent disease progression to moderate disease requiring hospitalisation.
The purpose of this double-blind trial is to evaluate the efficacy, reducing hospitalisation or death in non-hospitalised participants, and safety of a 3-day treatment with IV RDV in an outpatient setting in participants aged at least 12 years with confirmed COVID-19 who are at risk for disease progression.
Participants who meet all eligibility criteria will be randomised in a 1:1 ratio to RDV or placebo:
• Treatment Group A: single dose of IV RDV 200 mg on Day 1 followed by IV RDV 100 mg on Days 2 and 3
• Treatment Group B: IV placebo to match (PTM) RDV on Days 1 to 3The study consists of screening assessments, a 3-day treatment / assessment period, and day 7, 14 and 28 assessments. Assessments include physical examinations, vital signs, respiratory status, blood tests and questionnaire completion if available.
Approximately 1230 participants will participate worldwide.
Summary of Results
In total, 584 participants started the study. There were 22 participants who left the study before taking any study treatment, so the results in this section only include 562 participants. The difference between the remdesivir and placebo groups was significant. Overall, participants who received remdesivir were 87% less likely to need hospital care due to COVID-19 or die for any reason when compared to participants who took placebo. 2 out of 279 (1%) participants who took remdesivir required hospitalization or died due to COVID-19 by Day 28 and 15 out of 283 (5%) participants who received placebo required hospitalization or died by Day 28.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0383
Date of REC Opinion
20 Oct 2020
REC opinion
Further Information Favourable Opinion