drugset / Trial / NCT04745351
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to evaluate whether remdesivir (RDV, GS-5734™) reduces the composite risk of death or invasive mechanical ventilation (IMV) through Day 29 in participants with severely reduced kidney function who are hospitalized for coronavirus disease 2019 (COVID-19).
Timeline
- Start
- 2021-03-31
- Primary completion
- 2022-04-20
- Completion
- 2022-05-24
Outcome
Missed primary endpoint
Stopped (Enrollment): “The study was terminated due to study enrollment feasibility. This decision is not based on efficacy or safety concerns.”
registry analysis (superiority test); Remdesivir (RDV) vs Placebo; p = 0.6132; Hazard Ratio (HR) 0.816 (95% CI 0.504 to 1.321) NCT04745351 ↗
Publications
- Rodriguez L, Andreatta K, Chen S, Hu Y, Li J, Martin R, Han D, Moshiri J, Perry JK, Sise ME, Santos JR, Plate M, McPhail MJ, Koullias Y, Hyland RH, Hedskog C. Virologic insights from the phase 3 REDPINE trial: remdesivir in renally impaired and immunocompromised patients with COVID-19. Antimicrob Agents Chemother. 2026 Jul 10:e0191225. doi: 10.1128/aac.01912-25. Online ahead of print.
- Sise ME, Santos JR, Goldman JD, Tuttle KR, Teixeira JP, Seibert AF, Koullias Y, Llewellyn J, Regan S, Zhao Y, Huang H, Hyland RH, Osinusi A, Winter H, Humeniuk R, Hulter HN, Gottlieb RL, Fusco DN, Birne R, Stancampiano FF, Libertin CR, Small CB, Plate M, McPhail MJ; REDPINE Investigators. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial. Clin Infect Dis. 2024 Nov 22;79(5):1172-1181. doi: 10.1093/cid/ciae333.
- Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Remdesivir for the treatment of COVID-19. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remdesivir | Small molecule | 100 mg | Intravenous |