drugset / Trial / NCT04750317

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

NCT04750317

Non-randomizedParallel-groupOpen-labelTreatment

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 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.

Timeline

Start
2020-05-11
Primary completion
2020-08-01
Completion
2020-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 5 mg

Indications