Tocilizumab in severe COVID-19
- Conditions
- COVID-19.COVID-19U07.1
- Registration Number
- IRCT20150303021315N17
- Lead Sponsor
- Aryogen Pharmed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 85
?Ability to comprehend and willingness to sign the informed consent form for this study by ?the patient or his/her guardian
Patients above 18 years old?
Patients with fever higher than 37.8 °C, cough, shortness of breath, or respiratory rate higher than 30 breaths/min accompanied by SpO2 = %93, who ?have a confirmed diagnosis of SARS-CoV-2 infection using PCR and/or radiography.?
Serum Interleukin-6 level = 3 times upper limit of normal
History of hypersensitivity to Tocilizumab or any components of the formulation
Hepatic disease (especially active hepatic diseases and hepatic impairment)?
Patients with bone marrow suppression (defined as Absolute Neutrophil Count (ANC) below 2000/mm3 ?or platelet count below 100,000/mm3)?
Patients with a high risk of gastrointestinal perforation or with distinct history of GI disorders, e.g., active peptic ulcer and diverticulitis ?
Patients with active or latent tuberculosis ?
?Patients with history of active hepatitis B, hepatitis C, HIV, or any known immunodeficiency
Pregnant or lactating patients
Patients with any other active infection in addition to COVID-19
Patients with any other disease or disorder, which, in the opinion of the investigator will put the subject at risk, ?if they are enrolled
Renal impairment (GFR of below 30ml/min/1.73m2)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality rate during the study (date and cause of death, if applicable). Timepoint: day 1 through 14. Method of measurement: Physical Examination.
- Secondary Outcome Measures
Name Time Method