NCT04469114

Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia

Completed Phase 3 Last updated 9 August 2021

What this trial tests

Phase 3 trial testing Tofacitinib 10 mg in Covid19 in 289 participants. Completed in 9 January 2021.

Timeline

16 September 2020

Primary endpoint
9 January 2021

9 January 2021

Quick facts

Lead sponsor	Hospital Israelita Albert Einstein
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	289
Start date	16 September 2020
Primary completion	9 January 2021
Estimated completion	9 January 2021
Sites	17 locations across Brazil

Drugs / interventions tested

• Tofacitinib 10 mg — full drug profile →
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Hospital Israelita Albert Einstein

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The JAK/STAT signaling pathway: from bench to clinic.
   Hu X, Li J, Fu M, Zhao X, et al · · 2021 · cited 1761× · PMID 34824210 · DOI 10.1038/s41392-021-00791-1
2. The signal pathways and treatment of cytokine storm in COVID-19.
   Yang L, Xie X, Tu Z, Fu J, et al · · 2021 · cited 429× · PMID 34234112 · DOI 10.1038/s41392-021-00679-0
3. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia.
   Guimarães PO, Quirk D, Furtado RH, Maia LN, et al · · 2021 · cited 348× · PMID 34133856 · DOI 10.1056/nejmoa2101643
4. Janus kinase-targeting therapies in rheumatology: a mechanisms-based approach.
   Tanaka Y, Luo Y, O'Shea JJ, Nakayamada S. · · 2022 · cited 329× · PMID 34987201 · DOI 10.1038/s41584-021-00726-8
5. A Comprehensive Overview of Globally Approved JAK Inhibitors.
   Shawky AM, Almalki FA, Abdalla AN, Abdelazeem AH, et al · · 2022 · cited 222× · PMID 35631587 · DOI 10.3390/pharmaceutics14051001
6. The development of COVID-19 treatment.
   Yuan Y, Jiao B, Qu L, Yang D, et al · · 2023 · cited 147× · PMID 36776881 · DOI 10.3389/fimmu.2023.1125246
7. JAK-STAT Pathway Inhibition and their Implications in COVID-19 Therapy.
   Satarker S, Tom AA, Tom AA, Shaji RA, et al · · 2021 · cited 117× · PMID 33245005 · DOI 10.1080/00325481.2020.1855921
8. Neutrophil diversity and function in health and disease.
   Zhang F, Xia Y, Su J, Quan F, et al · · 2024 · cited 109× · PMID 39638788 · DOI 10.1038/s41392-024-02049-y