Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
Summary
The primary objectives of this study are to evaluate the efficacy of remdesivir (RDV) in reducing the rate of of coronavirus disease 2019 (COVID-19) related hospitalization or all-cause death in non-hospitalized participants with early stage COVID-19 and to evaluate the safety of RDV administered in an outpatient setting.
Timeline
- Start
- 2020-09-18
- Primary completion
- 2021-05-06
- Completion
- 2021-05-06
Outcome
Met primary endpoint
Stopped (Enrollment): “The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.”
registry analysis (superiority test); Remdesivir vs Placebo; p = 0.0076; Hazard Ratio (HR) 0.134 (95% CI 0.031 to 0.586); Regression, Cox NCT04501952 ↗
paper Covid-19-related hospitalization or death from any cause occurred in 2 patients (0.7%) in the remdesivir group and in 15 (5.3%) in the placebo group PMID 34937145 ↗
release “Phase 3 double-blind, placebo-controlled trial (PINETREE) demonstrating that a three-day course of Veklury treatment significantly reduced the risk of hospitalization” gilead.com ↗
release “Veklury demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28” gilead.com ↗
Publications
- Rodriguez L, Lee HW, Li J, Martin R, Han D, Xu S, Moshiri J, Peinovich N, Camus G, Perry JK, Hyland RH, Porter DP, Abdelghany M, Gotte M, Hedskog C. SARS-CoV-2 resistance analyses from the Phase 3 PINETREE study of remdesivir treatment in nonhospitalized participants. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0123824. doi: 10.1128/aac.01238-24. Epub 2024 Dec 19.
- Brown SM, Katz MJ, Ginde AA, Juneja K, Ramchandani M, Schiffer JT, Vaca C, Gottlieb RL, Tian Y, Elboudwarej E, Hill JA, Gilson R, Rodriguez L, Hedskog C, Chen S, Montezuma-Rusca JM, Osinusi A, Paredes R. Consistent Effects of Early Remdesivir on Symptoms and Disease Progression Across At-Risk Outpatient Subgroups: Treatment Effect Heterogeneity in PINETREE Study. Infect Dis Ther. 2023 Apr;12(4):1189-1203. doi: 10.1007/s40121-023-00789-y. Epub 2023 Apr 19.
- 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.
- Gottlieb RL, Vaca CE, Paredes R, Mera J, Webb BJ, Perez G, Oguchi G, Ryan P, Nielsen BU, Brown M, Hidalgo A, Sachdeva Y, Mittal S, Osiyemi O, Skarbinski J, Juneja K, Hyland RH, Osinusi A, Chen S, Camus G, Abdelghany M, Davies S, Behenna-Renton N, Duff F, Marty FM, Katz MJ, Ginde AA, Brown SM, Schiffer JT, Hill JA; GS-US-540-9012 (PINETREE) Investigators. Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients. N Engl J Med. 2022 Jan 27;386(4):305-315. doi: 10.1056/NEJMoa2116846. Epub 2021 Dec 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remdesivir | Small molecule | 100 mg | Intravenous |