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Study aim
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Comparisson of the effectiveness of Tocilizumab and Tofacitinib on the outcomes of patients with severe COVID-19
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Design
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Randomized open label clinical trial, with two arms with 1: 1 allocation ratio
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Settings and conduct
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This study will perform on severe COVID-19 patients admitted to Labbafinejad Hospital in 2022. Patients are divided into groups A and B and receive medication according to the protocol. The medical team will evaluate daily symptoms, laboratory tests, and overall outcomes for up to 14 days or discharge / death time.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Laboratory confirmation of COVID-19 virus by PCR, severe cases according to the World Health Organization guideline, body mass index less than 40 kg / m2, no immunosuppressive diseases, non-pregnant and non-lactating women, Serum CRP level greater than 75 mg / L, do not receive immunomodulatory drugs for 6 months before, no history of severe hypersensitivity to tosilizumab and tofacitinib, no history of active gastric ulcer, active diverticulitis and other gastrointestinal diseases with risk of intestinal perforation, no active hepatitis or tuberculosis or an infection other than COVID-19.
Exclusion criteria: severe drug allergy and anaphylactic shock, death in the first 24 hours of hospitalization, increase in liver enzymes to more than 10 times the normal upper limit, decrease in neutrophil count to less than 500 cells per microliter, decrease in platelet count to less than 50,000 cells per microliter, GFR less than 30 ml per minute.
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Intervention groups
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Group A will receive a dose of tosilizumab intravenous infusion (8 mg / kg up to a maximum of 800 mg). Group B will be treated with oral tofacitinib (10 mg every 12 hours for 14 days).
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Main outcome variables
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Death, hospitalization in intensive care unit, use of mechanical ventilation, hospitalization length