Status:
COMPLETED
Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 c...
Detailed Description
TOFA-COV-2 is a cohort study that is conducted in the three clinics of the Sechenov University (Moscow, Russia) in patients with moderately severe COVID-19 pneumonia. A diagnosis of COVID-19 associate...
Eligibility Criteria
Inclusion
- SARS-CoV2 Infection diagnosed by PCR and/or typical lesions on CT-scan (4 or 5 on CO-RADS scale) in combination with at least one of the following:
- oxygen saturation at rest ≤93% on ambient air,
- AND/OR C-reactive protein ≥50 mg/L,
- AND/OR fever (≥38.0°C) that persisted for at least two days despite treatment with nonsteroidal antiinflammatory drugs or paracetamol
- Written Informed Consent
Exclusion
- Age \<18 years
- Coexistent infection other than COVID-19
- Requirement for invasive mechanical ventilation
- Estimated glomerular filtration rate calculated using CKD-EPI formula ≤30 ml/min/1.73 m2;
- Elevated ALT and/or AST levels more than 3 times the upper limit of normal
- Chronic use of glucocorticoids or immunosuppressive agents
- Administration of interleukin-6 inhibitors and/or high-dose glucocorticoids (≥250 mg prednisone equivalent intravenously) for the treatment of COVID-19
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT04750317
Start Date
May 11 2020
End Date
September 1 2020
Last Update
February 15 2021
Active Locations (1)
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1
Sechenov First Moscow State Medical University (Sechenov University) - University Clinical Hospital
Moscow, Russia, 119991