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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200328046882N1

Enrollment

Registered

2020-04-05

Start date

2020-04-04

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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 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

Design outcomes

Primary

Measure	Time frame
Temperature( = 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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Alavi-Moghaddam

Shahid Beheshti University of Medical Sciences

mosalavi@sbmu.ac.ir+98 21 7754 3634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026