NCT05603143

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to test how well the study drug, obeldesivir (GS-5245), works and how safe it is in treating coronavirus disease 2019 (COVID-19) in participants that have a higher risk of getting a serious illness.

Conditions

• COVID-19

Interventions

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

Timeline

• Start date: 2022-11-05
• Primary completion: 2023-11-07
• Completion: 2023-11-07
• First posted: 2022-11-02
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

81 sites across 18 countries: Brazil, Bulgaria, Canada, France, Hungary, Italy, Japan, Mexico, Poland, Portugal, Romania, Singapore, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study