Efficacy and safety of tofacitinib on clinical improvement in patients with COVID19
Phase 3
Recruiting
- Conditions
- COVID-19 pneumonia.Covid-19 diseaseU07.1
- Registration Number
- IRCT20190804044429N7
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
Hospitalization with oxygen saturation less than 94%
COVID-19 diagnosis according to chest CT scan or RT-PCR
Exclusion Criteria
Pregnancy
lactating women
Severe liver failure (Child-pugh C) or liver enzymes more than 3 times normal
Renal failure (glomerular filtration less than 30 ml / min)
Chronic use of immunosuppressive drugs or corticosteroids
Absolute lymphocyte count less than 500 per cubic millimeter
Absolute neutrophil counts less than 1000 per cubic millimeter
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improving the clinical symptoms of patients with covid-19. Timepoint: Day one, day seven, day 14, day 28. Method of measurement: eight-category ordinal scale.
- Secondary Outcome Measures
Name Time Method Mortality rate. Timepoint: During hospitalization and on days 14 and 28. Method of measurement: Observation.;Admission in intensive care units. Timepoint: During hospitalization. Method of measurement: Observation.;Ventilator need. Timepoint: During hospitalization. Method of measurement: Observation.;Incidence of possible side effects. Timepoint: During hospitalization. Method of measurement: Observation.