Study Evaluating GS-5245 in Participants With COVID-19 Who Have a High Risk of Developing Serious or Severe Illness

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to test if GS-5245 is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• 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/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.

Key Exclusion Criteria:

• 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.