NCT05715528

Study of Obeldesivir in Nonhospitalized Participants With COVID-19

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 Nonhospitalized Participants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,011 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 12 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to test if obeldesivir (GS-5245) is safe and effective for the treatment of coronavirus disease 2019 (COVID-19) in participants who have a standard risk of developing severe illness. This study will also measure how much obeldesivir gets into the blood and how long it takes for the body to get rid of it.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Obeldesivir	Tablet administered orally without regard to food.
DRUG	Obeldesivir Placebo	Tablet administered orally without regard to food.

Timeline

• Start date: 2023-02-08
• Primary completion: 2023-11-28
• Completion: 2024-01-23
• First posted: 2023-02-08
• Last updated: 2024-12-24
• Results posted: 2024-12-24

Locations

113 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study