Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia

Sponsor
I.M. Sechenov First Moscow State Medical University
Study ID
NCT04750317
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tofacitinib — DRUG
    Tofacitinib was administered at a dose 10 mg twice daily on day 1, followed by 5 mg twice daily on day 2-5. The dosage was reduced up to 5 mg once daily in patients with moderate renal impairment or moderate hepatic impairment.

Study Details

TOFA-COV-2 is a cohort study of the efficacy of tofacitinib in reducing the risk of mechanical ventilation and/or death in patients with moderately severe COVID-19 pneumonia who received standard of care treatment (SoC). The study population consists of adults (≥18 years) with COVID-19, who are admitted to the university hospitals and don't require invasive or noninvasive ventilation on admission. All patients are divided into four groups depending on nadir levels of oxygen saturation and therapy: (1) patients with oxygen saturation ≤93% who received tofacitinib and SoC, (2) patients with oxygen saturation ≤93% who received only SoC, (3) patients with oxygen saturation \>93% who received tofacitinib and SoC, (4) patients with oxygen saturation \>93% who received only SoC. The aim of the study is to test the hypothesis that addition of tofacitinib to SoC could reduce the risk of mechanical ventilation and/or death.

Key Dates

Start date
May 11, 2020
Status verified
Feb 2021
Primary completion
Aug 1, 2020
Completion
Sep 1, 2020

Study Design

Enrollment
414 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with reduced oxygen saturation ≤93% treated with tofacitinib
    Patients with oxygen saturation ≤93% on admission treated with tofacitinib and standard of care treatment
  • No Intervention: Patients with reduced oxygen saturation treated with SoC
    Patients with oxygen saturation ≤93% on admission treated with standard of care only
  • Experimental: Patients with preserved oxygen saturation >93% on admission treated with tofacitinib
    Patients with oxygen saturation \>93% on admission treated with tofacitinib and standard of care
  • No Intervention: Patients with preserved oxygen saturation >93% on admission treated with SoC
    Patients with oxygen saturation \>93% on admission treated with standard of care only

Primary Outcome Measure

Death [ Time Frame: Within 28 days from admission ]

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