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IRCT20210901052358N3 IRCT 2022-04-01 Shahid Beheshti University of Medical Sciences Comparisson of the effectiveness of Tocilizumab and Tofacitinib on the outcomes of patients with severe COVID-19 Comparisson of the effectiveness of Tocilizumab and Tofacitinib on the outcomes of patients with severe COVID-19 2022-05-22 anticipated 60 Complete https://irct.ir/trial/62426 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE). N/A COVID-19. Intervention 1: Intervention group A: Group A will receive a dose of tosilizumab intravenous infusion (8 mg / kg to a maximum of 800 mg) in addition to routine treatment according to national protocol. Intervention 2: Intervention group B: Group B, in addition to routine treatment according to the national protocol, will be treated with oral tofacitinib (10 mg every 12 hours for 14 days). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Amirreza Keyvanfar
No. 2, 2nd east Ave., Imam Reza St., Takhti St., Ashrafi esfahani Highway.
Tehran Iran (Islamic Republic of) 1477695469 +98 21 4483 1899 amirrezakeyvanfar@yahoo.com Shahid Beheshti University of Medical Sciences scientific Amirreza Keyvanfar
No. 2, 2nd east Ave., Imam Reza St., Takhti St., Ashrafi esfahani Highway.
Tehran Iran (Islamic Republic of) 1477695469 +98 21 4483 1899 amirrezakeyvanfar@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Laboratory confirmation of COVID-19 virus by PCR Severe cases according to the World Health Organization guideline (peripheral blood oxygen saturation less than 90%, respiratory rate more than 30 per minute or symptoms of severe respiratory distress such as use of auxillary respiratory muscles or inability to complete sentences) Body mass index less than 40 kg per square meter No immunosuppressive diseases (primary, secondary and organ transplant defects, chemotherapy or radiotherapy) Patient willingness to participate in the study 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 and similar compounds No history of active gastric ulcer, active diverticulitis and other gastrointestinal diseases with risk of intestinal perforation No active hepatitis or tuberculosis or a bacterial or fungal or viral infection other than COVID-19 No history of chronic kidney disease (GFR less than 30 ml / min) 18 years no limit Both 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 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group A: Group A will receive a dose of tosilizumab intravenous infusion (8 mg / kg to a maximum of 800 mg) in addition to routine treatment according to national protocol. Intervention group B: Group B, in addition to routine treatment according to the national protocol, will be treated with oral tofacitinib (10 mg every 12 hours for 14 days). Mortality. Timepoint: Until the 14th day of hospitalization or discharge / death. Method of measurement: Patient medical record. Admission to the intensive care unit. Timepoint: Until the 14th day of hospitalization or discharge / death. Method of measurement: Patient medical record. Use of mechanical ventilation. Timepoint: Until the 14th day of hospitalization or discharge / death. Method of measurement: Patient medical record. Hospitalization length. Timepoint: Until the 14th day of hospitalization or discharge / death. Method of measurement: Patient medical record. Body temperature. Timepoint: Daily and up to 14 days daily or discharge / death time. Method of measurement: Thermometer. Respiratory rate. Timepoint: Daily and up to 14 days daily or discharge / death time. Method of measurement: Physical examination by physician. Oxygen saturation. Timepoint: Daily and up to 14 days daily or discharge / death time. Method of measurement: Pulse oximeter. Serum CRP level. Timepoint: Daily and up to 14 days daily or discharge / death time. Method of measurement: Laboratory report. Serum LDH level. Timepoint: Daily and up to 14 days daily or discharge / death time. Method of measurement: Laboratory report. Shahid Beheshti University of Medical Sciences Approved 2022-03-12 Organizational Committee of Ethics in Biomedical Research, Shahid Beheshti University of Medical Sci Shahid Beheshti University of medical sciences, Arabi St., Daneshjoo Blvd,. Yaman St,. Chamran highway. Tehran Tehran Iran (Islamic Republic of)