Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial

Phase 2

Recruiting

Conditions: SARS-CoV-2 ?associated SARI.
SARS-CoV-2
U07.1

Registration Number: IRCT20200328046882N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.