COVID-19 trials registries data warehouse

http://en.irct.ir/trial/62426

Dr. Afshin Zarghi

Mpajouhesh@sbmu.ac.ir

2022-04-01

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

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)

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

2

Shahid Beheshti University of Medical Sciences

18

100

Iran

Severe disease at enrollment

6: Severe disease at enrollment

60

Mortality Admission to the intensive care unit Use of mechanical ventilation Hospitalization length

Not reported

[{"arm_notes": "", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1300, "treatment_name": "Tofacitinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]