Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia

Sponsor
Hospital Israelita Albert Einstein
Study ID
NCT04469114
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 10 mg — DRUG
    Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge
  • Placebo — DRUG
    Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge

Study Details

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.

Key Dates

Start date
Sep 16, 2020
Status verified
Jul 2020
Primary completion
Jan 9, 2021
Completion
Jan 9, 2021

Study Design

Enrollment
289 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    Tofacitinib 10mg twice daily for 14 days or until hospital discharge
  • Placebo Comparator: Placebo
    Placebo twice daily for 14 days or until hospital discharge

Primary Outcome Measure

Death or respiratory failure until Day 28 [ Time Frame: 28 days ]

Related Studies