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IRCT20151227025726N29 IRCT 2022-02-16 Iran University of Medical Sciences Evaluation of the Effects of Tocilizumab Administration in Hospitalized COVID-19 Patients Evaluation of the Effects of Tocilizumab Administration in the Cytokine Release Phase on the CT Scan Findings and Clinical Outcomes in Hospitalized COVID-19 Patients 2022-02-20 anticipated 50 Complete https://irct.ir/trial/61644 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 COVID-19 pneumonia. Intervention group: Dilute 400 mg of ACTEMRA (Tocilizumab) in at least 100 ml of normal saline 0.9 and give it slowly intravenously over at least one hour. The drug should be given at 2 to 8 ° C before injection. Store in the refrigerator.. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding. When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers through Email (fzh.dastan@gmail.com) Comments:
public Sahar Yousefian
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2227 saahar26@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ghazaleh Amjad
School of Medicine, Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 amjad.gh@oums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients between 18 and 70 years old Laboratory confirmed COVID-19 with RT-PCR Be in severe or critical stage of the disease Have interleukin-6 levels above 15 picogram per milliliter or CRP above 100 miligram per liter 18 years 70 years Both Acute or chronic renal failure (Increase in creatinine by more than 3.0 in the last 48 hours or GFR less than 30 mL/min) Liver failure (more than 5-fold increase in liver enzymes in asymptomatic patients or more than 3-fold increase in liver enzymes in symptomatic patients or Child Pugh C, D) Hypersensitivity reaction during tocilizumbe injection with severe extrusion and symptoms of anaphylactic shock Mild stage of the disease Pregnant and lactating patients Patients with platelets less than 100,000 or ANC less than 5 Patients with Latent TB or Active TB or any active infection History of active gastric ulcer Patients with positive viral marker U07.1 COVID-19 Treatment - Drugs Intervention group: Dilute 400 mg of ACTEMRA (Tocilizumab) in at least 100 ml of normal saline 0.9 and give it slowly intravenously over at least one hour. The drug should be given at 2 to 8 ° C before injection. Store in the refrigerator. Mortality. Timepoint: Days 7, 14 and 21 of hospitalization. Method of measurement: Medical record. Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record. Lung radiological changes. Timepoint: Before receiving tocilizumab and after discharge. Method of measurement: Computed tomography. Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record. Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record. Iran University of Medical Sciences Approved 2021-05-17 Ethics Committee of Medical School-Iran University of Medical Sciences School of Medicine, Iran University of Medical Sciences, Hemmat Highway next to Milad Tower Tehran Tehran Iran (Islamic Republic of)