Study of Obeldesivir in Nonhospitalized Participants With COVID-19

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.

Timeline

Start

2023-02-08

Primary completion

2023-11-28

Completion

2024-01-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Obeldesivir vs Placebo; p = 0.0681; Hazard Ratio (HR) 1.099 (95% CI 0.997 to 1.211) NCT05715528 ↗

paper However, obeldesivir did not significantly reduce time to symptom alleviation PMID 40675167 ↗

release “Announced that the Phase 3 OAKTREE trial of obeldesivir in non-hospitalized participants without risk factors for developing severe COVID-19 did not meet its primary endpoint” gilead.com ↗

Publications

• Rodriguez L, Hu Y, Li J, Han D, Peinovich N, Martinez C, Ho PY, Perry JK, Martin R, Ogbuagu O, Lichtman A, Hyland RH, Hedskog C. SARS-CoV-2 resistance analyses from the Phase 3 OAKTREE study of obeldesivir in low-risk nonhospitalized participants with COVID-19. Antiviral Res. 2026 Mar;247:106339. doi: 10.1016/j.antiviral.2025.106339. Epub 2025 Dec 29.
• Ogbuagu O, Goldman JD, Gottlieb RL, Singh U, Shinkai M, Acloque G, Fusco DN, Gonzalez E, Kumar P, Luetkemeyer A, Lichtman A, Mozaffarian A, Koullias Y, Hyland RH, Llewellyn J, Osinusi A, Duff F, Humeniuk R, Caro L, Davies S, Rodriguez L, Hedskog C, Chen S, Etchevers K, Nadig P, Kohli A; OAKTREE Trial Investigators. Efficacy and safety of obeldesivir in low-risk, non-hospitalised patients with COVID-19 (OAKTREE): a phase 3, randomised, double-blind, placebo-controlled study. Lancet Infect Dis. 2025 Dec;25(12):1282-1292. doi: 10.1016/S1473-3099(25)00238-5. Epub 2025 Jul 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obeldesivir	Small molecule	350 mg	Oral

Indications