Study Evaluating GS-5245 in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness
- Conditions
- Infectious disease caused by the SARS-CoV-2COVID19
- Registration Number
- JPRN-jRCT2031220645
- Lead Sponsor
- eda Hiroki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2300
Willing and able to provide written informed consent.
- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed with an assay 5 days before randomization.
- Initial onset of COVID-19 signs or symptoms 5 days before randomization.
- Not currently hospitalized or requiring hospitalization.
- Presence of 1 risk factor (if unvaccinated) or 2 risk factors (if vaccinated at any point) for progression to severe disease. Vaccinated individuals are eligible for enrollment only if it has been at least 4 months since the most recent dose, including boosters.
- Anticipated use of COVID-19 therapies during the current COVID-19 illness.
- Received any direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before randomization.
- Anticipated need for hospitalization < 48 hours after randomization.
- New oxygen requirement < 24 hours before randomization.
- Cirrhosis or acute liver injury/failure.
- Undergoing dialysis, or history of moderate to severe renal impairment.
- Pregnant or breastfeeding (nursing).
- Unwilling to use protocol-mandated birth control.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method