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

• Register: IRCT
• Last refreshed on: 21 April 2020
• Main ID: IRCT20200328046882N1
• Date of registration: 2020-04-05
• Prospective Registration: No
• Primary sponsor: Shahid Beheshti University of Medical Sciences
• Public title: Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial
• Scientific title: Efficacy and safety of Sofosbuvir in the treatment of SARS-CoV-2: An Open Label phase II Trial
• Date of first enrolment: 2020-04-04
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/46784
• Study type: interventional
• Study design: 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.
• Phase: 2

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Mostafa Alavi-Moghaddam
• Affiliation: Shahid Beheshti University of Medical Sciences

• Name: Mostafa Alavi-Moghaddam
• Affiliation: Shahid Beheshti University of Medical Sciences

Key inclusion & exclusion criteria

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

Age minimum: 18 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

SARS-CoV-2 ?associated SARI.
SARS-CoV-2

U07.1

Intervention(s)

Intervention 1: Intervention group ?: Sofosbuvir 400mg OD for 5 days+ standard treatment. Intervention 2: Intervention group: Sofosbuvir 400mg OD for 10 days+ standard treatment.

Primary Outcome(s)

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(s)

All causes mortality. Timepoint: During 14 days after enrollment in the study. Method of measurement: As defined in ACLS protocol.

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.

Length of stay in hospital. Timepoint: Time duration between admission date and discharge date. Method of measurement: Calculation.

Source(s) of Monetary Support

Shahid Beheshti University of Medical Sciences

Ethics review

Status: Approved
Approval date: 28/03/2020
Contact:

Ethics committee of Shahid Beheshti University of Medical sciences