Efficacy and Safety of Tofacitinib in Patients With COVID-19 Pneumonia (TOFA-COV-2)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- Sechenov First Moscow State Medical University (Sechenov University) - University Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
Experimental
No Intervention
Patients with reduced oxygen saturation ≤93% treated with tofacitinib
Patients with reduced oxygen saturation treated with SoC
Patients with preserved oxygen saturation >93% on admission treated with tofacitinib
Patients with preserved oxygen saturation >93% on admission treated with SoC
Patients with oxygen saturation ≤93% on admission treated with tofacitinib and standard of care treatment
Patients with oxygen saturation ≤93% on admission treated with standard of care only
Patients with oxygen saturation >93% on admission treated with tofacitinib and standard of care
Patients with oxygen saturation >93% on admission treated with standard of care only