Evaluating GS-5245 in Participants with COVID-19 at High Risk of Developing Serious/Severe Illness
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-5245 for the Treatment of COVID-19 in Participants With High-Risk for Disease Progression
IRAS ID
1006352
Contact name
Robert Hyland
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2022-002741-18
Clinicaltrials.gov Identifier
Research summary
This is a clinical research study aimed at individuals that have been diagnosed with COVID-19 with high risk for disease progression. The purpose of this study is to to see if GS-5245 is safe and effective for the treatment of COVID-19 in people who have a high risk of developing serious or severe illness. The study will also measure how much GS-5245 gets into the blood and how long it takes the body to get rid of it.
The study will enrol about 3150 participants and will take place at up to 300 locations globally, including in the UK.
This is a randomised, double-blind, placebo-controlled study.
Randomised means the study treatment the participant will take will be chosen by chance—like flipping a coin. The participant will have 1 out of 2 (50%) chances to receive GS-5245 (350 milligrams tablet twice daily) and 1 out of 2 chances to receive placebo (twice daily).
Double-blind means neither the participant and not the study doctor will not know what study drug the participant will be taking.
Placebo-controlled means that the participant may be taking a tablet with no medicine in it that looks like GS-5245. As there are no approved treatments for COVID-19 in the country , the study drug will be compared to placebo.
The participant cannot choose which group they are in. If they agree to take part in this study and meet all the requirements, they will be placed in one of the following treatment groups:
Treatment Group 1: 1 x 350 mg tablet of GS-5245 by mouth twice daily for 5 days
Treatment Group 2: 1 x tablet of placebo by mouth twice daily for 5 days
GS-5245 and placebo will be supplied by Gilead, who is also the Sponsor of this study.COVID-19 is a cause of an ongoing global pandemic with Intravenous remdesivir being the first antiviral treatment approved by regulatory agencies in the United Kingdom, United States, European Union and other countries. More convenient options are needed for early intervention in the nonhospitalized COVID-19 population.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0232
Date of REC Opinion
30 Jan 2023
REC opinion
Further Information Favourable Opinion