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IRCT20200328046882N1 IRCT 2020-04-05 Shahid Beheshti University of Medical Sciences Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial 2020-04-04 anticipated 60 Complete https://irct.ir/trial/46784 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients in the study arms will be done by using table of random numbers, without concealment, Blinding description: Allocation of the patients in to groups A or B will be randomized. Physicians who involve in the care of the patients will not be blinded. Principle Investigator who will assess the outcomes and the statistician who will analyze the data all will be blinded. 2 SARS-CoV-2 َassociated SARI. Intervention 1: Intervention group َ: Sofosbuvir 400mg OD for 5 days+ standard treatment. Intervention 2: Intervention group: Sofosbuvir 400mg OD for 10 days+ standard treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mostafa Alavi-Moghaddam
Clinical Research Development Center-Imam Hossein Hospital, Shahid Madani Ave.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7754 3634 mosalavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mostafa Alavi-Moghaddam
Clinical Research Development Center-Imam Hossein Hospital, Shahid Madani Ave.
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7754 3634 mosalavi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Written informed consent prior to performing study procedures (SARS-CoV)-2 infection confirmed (PCR) test ≤ 4 days before randomization Currently hospitalized with fever Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening Radiographic evidence of pulmonary infiltrates 18 years no limit Both Participation in any other clinical trial of an experimental treatment for COVID-19 Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study drug dosing Evidence of multi-organ failure Requiring mechanical ventilation at screening Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) Creatinine clearance <30mL/min pregnant woman or man who his spouse is pregnant Coadministration of amiodarone, HIV Protease Inhibitors, rifabutin or rifapentine , phenobarbital or oxcarbazepine U07.1 SARS-CoV-2 Treatment - Drugs Treatment - Drugs Intervention group َ: Sofosbuvir 400mg OD for 5 days+ standard treatment Intervention group: Sofosbuvir 400mg OD for 10 days+ standard treatment Temperature( < 36.6 °C armpit, or < 37.2 °C oral, ) without using antipyretic drugs sustained for at least 72 hours. Timepoint: ِDuring 14 days after enrollment in the study. Method of measurement: Digital Thermometer. Spo2>= 94% (at room air) sustained for at least 72 hours without Oxygen therapy. Timepoint: During 14 days after enrollment in the study. Method of measurement: Pulse Oximeter. All causes mortality. Timepoint: During 14 days after enrollment in the study. Method of measurement: As defined in ACLS protocol. Length of stay in hospital. Timepoint: Time duration between admission date and discharge date. Method of measurement: Calculation. Transfer to ICU due to need of mechanical ventilation. Timepoint: During 14 days after enrollment in the study. Method of measurement: Patient Chart review. Report of Sofosbuvir adverse reactions need to stop the treatment. Timepoint: During 14 days after enrollment in the study. Method of measurement: physician judgement. Shahid Beheshti University of Medical Sciences Approved 2020-03-28 Ethics committee of Shahid Beheshti University of Medical sciences 5th Floor, Bldg No 2, Shahid Beheshti Medical Sciences University Arabi Ave,Velenjak Tehran ,IRAN Tehran Tehran Iran (Islamic Republic of)