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IRCT20151227025726N27 IRCT 2021-09-25 Shahid Beheshti University of Medical Sciences Comparison of Inhaled Tocilizumab with Intravenous Tocilizumab in hospitalized patients with COVID-19 Evaluation of Efficacy and Safety of Inhaled Tocilizumab in Comparison with Intravenous Tocilizumab in Hospitalized Patients with COVID-19 2021-09-23 anticipated 100 Complete https://irct.ir/trial/58443 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Twenty five blocks including 4 patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, 2 patients will be assigned to inhaled tocilizumab group and 2 patients will be assigned to intravenous tocilizumab group. 3 COVID-19 pneumonia. Intervention 1: Case group: At first receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, 400 mg tocilizumab (Temziva, Cinnagen) will be administered by nebulization method (5 cc every 6 hours) . Intervention 2: Control group: At first receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, 400 mg tocilizumab (Temziva, Cinnagen) will be administered by intravenous infusion during one hour. 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 Hamidreza Jamaati
Masih Daneshvari Hospital, Shahid Bahonar Street (Niyavaran), Darabad.
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2020 hamidjamaati@hotmail.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 (Corona Virus Disease-19) with RT-PCR (Real-Time Polymerase Chain Reaction) or CT scan. Have signed the consent form. O2 saturation < 90% (at room air) or lung involvement >50% or respiratory rate >30 CRP > 75 mg/l IL-6 > 15 pg/ml 18 years 100 years Both Allergy to Tocilizumab or one of the components of drug formulations. ANC < 500 cells/mm Pelatelet < 50000 cells/mm Hepatic transaminases > 5 times normal range or mild increase in liver transaminases associated with signs and symptoms of liver disorder History of malignancy Diverticulitis Positive procalcitonin and active infection (including latent or active tuberculosis infection) Taking other rheumatoid drugs at the same time COVID-19, U07.1 Treatment - Drugs Treatment - Drugs Case group: At first receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, 400 mg tocilizumab (Temziva, Cinnagen) will be administered by nebulization method (5 cc every 6 hours) . Control group: At first receive 400 mg tocilizumab by intravenous infusion during one hour. After 12 hours, 400 mg tocilizumab (Temziva, Cinnagen) will be administered by intravenous infusion during one hour. 28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record. Need for mechanical ventilation. Timepoint: Daily until discharge. Method of measurement: Medical record. Oxyganation rate. 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. Length of hospital stay. 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. Inflammation biomarkers (CRP، IL-6، LDH، Ferritin). Timepoint: Before first dose and 72 hours after second dose. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2021-06-10 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)