drugset / Trial / NCT04421027
A Study of Baricitinib (LY3009104) in Participants With COVID-19
RandomizedParallel-groupDouble-blindTreatment
Summary
The reason for this study is to see if the study drug baricitinib is effective in hospitalized participants with COVID-19.
Timeline
- Start
- 2020-06-12
- Primary completion
- 2021-02-12
- Completion
- 2021-06-10
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo + SOC vs Baricitinib + SOC; p = 0.1800; Odds Ratio (OR) 0.85 (95% CI 0.67 to 1.08); Regression, Logistic NCT04421027 ↗
registry analysis (superiority test); Placebo + SOC vs Baricitinib + SOC; p = 0.7280; Odds Ratio (OR) 1.12 (95% CI 0.58 to 2.16); Regression, Logistic NCT04421027 ↗
paper Although there was no significant reduction in the frequency of disease progression overall, PMID 34480861 ↗
Publications
- Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.
- Ely EW, Ramanan AV, Kartman CE, de Bono S, Liao R, Piruzeli MLB, Goldman JD, Saraiva JFK, Chakladar S, Marconi VC; COV-BARRIER Study Group. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. Lancet Respir Med. 2022 Apr;10(4):327-336. doi: 10.1016/S2213-2600(22)00006-6. Epub 2022 Feb 3.
- Marconi VC, Ramanan AV, de Bono S, Kartman CE, Krishnan V, Liao R, Piruzeli MLB, Goldman JD, Alatorre-Alexander J, de Cassia Pellegrini R, Estrada V, Som M, Cardoso A, Chakladar S, Crowe B, Reis P, Zhang X, Adams DH, Ely EW; COV-BARRIER Study Group. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. Lancet Respir Med. 2021 Dec;9(12):1407-1418. doi: 10.1016/S2213-2600(21)00331-3. Epub 2021 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 4 mg | Oral |