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IRCT20151227025726N15 IRCT 2020-05-18 Shahid Beheshti University of Medical Sciences Evaluating the effects of Umifenovir (Arbidol) in COVID-19 Evaluation the efficacy and safety of Umifenovir (Arbidol) Administration in comparison with Lopinavir-ritonavir (Kaletra) in COVID-19 patients 2020-04-08 anticipated 100 Complete https://irct.ir/trial/48018 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. 25 blocks including 4 patients generated with online website. In each block, two patients will be assigned to Umifenovir group and two patients will be assigned to Lopinavir-ritonavir group. 3 COVID-19 pneumonia. Intervention 1: Intervention group: Patients in Umifenovir received Umifenovir 200 mg TDS for 7 days. Intervention 2: Control group: Patients received Lopinavir-Ritonavir 50-200 mg in 2 Tab BID for 7 days. 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 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 Comments:
public 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 scientific 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 Iran (Islamic Republic of) Laboratory confirmed COVID-19 with RT-PCR Oxygen saturation < 93% Fever more than 72 hours before admission Bilateral pulmonary infiltration Age over 18 years old 18 years 100 years Both Chronic kidney disease (Stage IV and V) Acute kidney injury Pregnancy or breastfeeding Drug allergy history Chronic liver disease (Child pugh C) Mild phase of COVID-19 Critical phase of COVID-19 U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Patients in Umifenovir received Umifenovir 200 mg TDS for 7 days. Control group: Patients received Lopinavir-Ritonavir 50-200 mg in 2 Tab BID for 7 days. 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. Death. Timepoint: At the end of the study. Method of measurement: Medical record. Need of mechanical ventilation. Timepoint: Daily. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2020-04-06 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)