COVID-19. COVID-19, virus identified
Conditions
Interventions
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
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmirreza Keyvanfar
Shahid Beheshti University of Medical Sciences
Outcome results
None listed