Evaluation the Efficacy and Safety of Tocilizumab in COVID-19
Phase 2
Recruiting
- Conditions
- COVID-19 pneumonia.Confirmed diagnosis of COVID-19RA01.0
- Registration Number
- IRCT20151227025726N13
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Laboratory confirmed COVID-19 with RT-PCR
Respiratory rate > 30/min
Oxygen saturation < 90%
PaO2/FiO2 < 300mmHg
High level of serum Interleukin-6
Age over 18 years old
Exclusion Criteria
Chronic kidney Disease
Acute kidney injury
Pregnancy or breastfeeding
Drug allergy history
Pneumonia due to influenza virus, bacterial pneumonia, fungal pneumonia, and noninfectious causes
Chronic liver disease
History of latent or active tuberculosis
Patients with human immunodeficiency virus
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fever. Timepoint: Daily. Method of measurement: Thermometer.;Cough. Timepoint: Daily. Method of measurement: Observation.;Dyspnea. Timepoint: Daily. Method of measurement: Observation.
- Secondary Outcome Measures
Name Time Method Hospitalization duration. Timepoint: At admission time and discharge time. Method of measurement: Clinical records.;Lung radiology changes. Timepoint: At admission time and seven and 14 days later. Method of measurement: Computed tomography.;Adverse Drug Reaction. Timepoint: Daily. Method of measurement: Observation.;Virological clearance. Timepoint: At admission time and seven and 14 days later. Method of measurement: Reverse transcription polymerase chain reaction.