Comparisson of the effectiveness of Tocilizumab and Tofacitinib on the outcomes of patients with severe COVID-19

Not Applicable

• Conditions: COVID-19.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20210901052358N3
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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)

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.