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

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.

Timeline

Start

2022-11-05

Primary completion

2023-11-07

Completion

2023-11-07

Outcome

Missed primary endpoint

Stopped: “The study was stopped early as it was determined there would not be a statistically significant treatment effect associated with the primary endpoint due to the low number of events.”

paper 0 of 211 (0%) participants with obeldesivir and 1 of 207 (0.5%) participants with placebo (log-rank P = .32) PMID 40694627 ↗

Publications

• Hedskog C, Rodriguez L, Hu Y, Li J, Han D, Peinovich N, Martinez C, Ho PY, Perry JK, Gonzalez Del Castillo JM, Koullias Y, Martin R, Hyland RH. SARS-CoV-2 resistance analyses from the Phase 3 BIRCH study of obeldesivir in high-risk nonhospitalized participants with COVID-19. Antiviral Res. 2026 Mar;247:106351. doi: 10.1016/j.antiviral.2026.106351. Epub 2026 Jan 19.
• Streinu-Cercel A, Castagna A, Chang SC, Chen YS, Koullias Y, Mozaffarian A, Hyland RH, Humeniuk R, Caro L, Davies S, Rodriguez L, Hedskog C, Chen S, Etchevers K, Behenna-Renton N, Llewellyn J, Osinusi A, Duff F, Barrat Hernandez A, McNally D, Simon-Campos JA, Leal FE, Fouche LF, Gonzalez Del Castillo JM. Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With COVID-19 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study. Clin Infect Dis. 2026 Feb 9;82(1):e24-e32. doi: 10.1093/cid/ciaf406.

Drugs

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

Indications