Evaluation of the Effectiveness of Two Different Regimens Based on Tosilizumab and Baricitinib in Patients with COVID-19
Phase 3
- Conditions
- COVID-19 pneumonia.COVID-19, virus identifiedU07.1
- Registration Number
- IRCT20151227025726N30
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients between 18 and 100 years old
Laboratory confirmed COVID-19 with RT-PCR
Be in severe stage of the disease
Have signed the consent to participate in the study
Exclusion Criteria
Acute or chronic renal failure (Increase in creatinine by more than 3.0 in the last 48 hours or GFR less than 30 mL/min)
Liver failure (more than 5-fold increase in liver enzymes in asymptomatic patients or more than 3-fold increase in liver enzymes in symptomatic patients or Child Pugh C, D)
Hypersensitivity reaction to tocilizumab or baricitinib with severe extravasation and symptoms of anaphylactic shock
Mild stage of the disease
Pregnant and lactating patients
Patients who have been intubated
Patients who are expected to die in the next 48 hours
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record.;Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record.
- Secondary Outcome Measures
Name Time Method ength of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record.;Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: First day of the study then at discharge. Method of measurement: Computed tomography.;Need for a second dose of tosilizumab. Timepoint: Daily until discharge. Method of measurement: Medical record.