]>
IRCT20151227025726N13 IRCT 2020-03-26 Shahid Beheshti University of Medical Sciences Evaluation the Efficacy and Safety of Tocilizumab in COVID-19 Evaluation the Efficacy and Safety of Tocilizumab in Patients with Novel Coronavirus (COVID-19) 2020-03-11 anticipated 40 Complete https://irct.ir/trial/46681 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 COVID-19 pneumonia. Intervention group: Tab Hydroxychloroquine 400 mg P.O. BID for five days plusTab Oseltamivir 75 mg P.O. BID for five days plus Tab Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for five days plus Tocilizumab (Actemra) 400 mg I.V infusion as a single dose. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six mounts after publishing To whom: Researchers working in academic institutions Conditions: For research purposes Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers Comments:
public Farzaneh Dastan
Valieasr St., Intersection of Niyayesh Highway, Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Payam Tabarsi
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 3000 tabarsi@nritld.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Laboratory confirmed COVID-19 with RT-PCR Respiratory rate > 30/min Oxygen saturation < 90% PaO2/FiO2 < 300mmHg High level of serum Interleukin-6 Age over 18 years old 18 years no limit Both Chronic kidney Disease Acute kidney injury Pregnancy or breastfeeding Drug allergy history Pneumonia due to influenza virus, bacterial pneumonia, fungal pneumonia, and noninfectious causes Chronic liver disease History of latent or active tuberculosis Patients with human immunodeficiency virus RA01.0 Confirmed diagnosis of COVID-19 Treatment - Drugs Intervention group: Tab Hydroxychloroquine 400 mg P.O. BID for five days plusTab Oseltamivir 75 mg P.O. BID for five days plus Tab Lopinavir-Ritonavir 200/50 mg P.O. two tablets BID for five days plus Tocilizumab (Actemra) 400 mg I.V infusion as a single dose Fever. Timepoint: Daily. Method of measurement: Thermometer. Cough. Timepoint: Daily. Method of measurement: Observation. Dyspnea. Timepoint: Daily. Method of measurement: Observation. Hospitalization duration. Timepoint: At admission time and discharge time. Method of measurement: Clinical records. Lung radiology changes. Timepoint: At admission time and seven and 14 days later. Method of measurement: Computed tomography. Adverse Drug Reaction. Timepoint: Daily. Method of measurement: Observation. Virological clearance. Timepoint: At admission time and seven and 14 days later. Method of measurement: Reverse transcription polymerase chain reaction. Shahid Beheshti University of Medical Sciences Approved 2020-03-10 National Research Institute of Tuberculosis and Lung Diseases Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran Tehran Tehran Iran (Islamic Republic of)