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IRCT20151227025726N30 IRCT 2022-02-28 Shahid Beheshti University of Medical Sciences Evaluation of the Effectiveness of Two Different Regimens Based on Tosilizumab and Baricitinib in Patients with COVID-19 Evaluation of the Effectiveness of Two Different Regimens Based on Tosilizumab and Baricitinib in Patients with COVID-19 Respiratory Distress Syndrome 2022-03-11 anticipated 60 Complete https://irct.ir/trial/61974 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Fifteen blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to baricitinib group and 2 patients will be assigned to tocilizumab group, Blinding description: Investigator is blind to the study groups until the end of the study. 3 COVID-19 pneumonia. Intervention 1: Intervention group: In addition to receiving tosilizumab at a dose of 400 mg by slow intravenous injection, patients receive baricitinib as a dose of 4 mg daily for 14 days or until discharge. Intervention 2: Control group: Patients receive a single dose of 400 mg tosilizumab as a slow intravenous injection. 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 Farzaneh Dastan
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 2712 2227 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients between 18 and 100 years old Laboratory confirmed COVID-19 with RT-PCR Be in severe stage of the disease Have signed the consent to participate in the study 18 years 100 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 to tocilizumab or baricitinib with severe extravasation and symptoms of anaphylactic shock Mild stage of the disease Pregnant and lactating patients Patients who have been intubated Patients who are expected to die in the next 48 hours U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: In addition to receiving tosilizumab at a dose of 400 mg by slow intravenous injection, patients receive baricitinib as a dose of 4 mg daily for 14 days or until discharge. Control group: Patients receive a single dose of 400 mg tosilizumab as a slow intravenous injection. 28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record. Need for intubation. Timepoint: Daily until discharge. Method of measurement: Medical record. Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record. Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record. Lung radiological changes. Timepoint: First day of the study then at discharge. Method of measurement: Computed tomography. Need for a second dose of tosilizumab. Timepoint: Daily until discharge. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2022-01-25 Ethics Committe of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)