Evaluation of the Effects of Tocilizumab Administration in Hospitalized COVID-19 Patients
- Conditions
- COVID-19 pneumonia.COVID-19U07.1
- Registration Number
- IRCT20151227025726N29
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients between 18 and 70 years old
Laboratory confirmed COVID-19 with RT-PCR
Be in severe or critical stage of the disease
Have interleukin-6 levels above 15 picogram per milliliter or CRP above 100 miligram per liter
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 during tocilizumbe injection with severe extrusion and symptoms of anaphylactic shock
Mild stage of the disease
Pregnant and lactating patients
Patients with platelets less than 100,000 or ANC less than 5
Patients with Latent TB or Active TB or any active infection
History of active gastric ulcer
Patients with positive viral marker
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality. Timepoint: Days 7, 14 and 21 of hospitalization. Method of measurement: Medical record.;Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record.;Lung radiological changes. Timepoint: Before receiving tocilizumab and after discharge. Method of measurement: Computed tomography.
- Secondary Outcome Measures
Name Time Method umber of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record.;Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record.