Efficacy and safety of sofosbuvir in the treatment of SARS-CoV-2: an open label phase II trial

Mostafa Alavi-Moghaddam; Mohammad Sistanizad; Mehrdad Haghighi; Tahereh Sabaghian; Bahare Gholami Chaboki; Zahra Soroureddin

doi:10.18502/fem.v7i1.11697

Mostafa Alavi-Moghaddam Emergency Medicine Department, Imam Hossein Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad Sistanizad Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mehrdad Haghighi Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Tahereh Sabaghian Nephrology Department, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Bahare Gholami Chaboki Biostatistics Department, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Zahra Soroureddin Prevention of Cardiovascular disease Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

DOI: https://doi.org/10.18502/fem.v7i1.11697

Keywords: Antiviral Agents; COVID-19; SARS-Cov-2; Sofosbuvir

Abstract

Objective:

Despite the worldwide spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), an effective specific antiviral treatment for coronavirus disease of 2019 (COVID-19) is yet to be identified .We did this study to investigate the safety and efficacy of sofosbuvir as antiviral therapy among hospitalized adult patients with SARS-CoV-2.

Methods:

Patients were randomized into intervention arm receiving sofosbuvir or comparison arm receiving usual antiviral agents in addition to standard of care. The primary end point of the study was clinical recovery as defined by normal body temperature and normal oxygen saturation. The main secondary outcome was all-cause mortality during the admission in hospital or within 14 days after discharge if applicable. Reports of severe adverse events were observed in the intervention arm.

Results:

Fifty-seven patients enrolled into either the clinical trial arm (n=27) or the comparison arm (n=30). Primary outcome was achieved by 24 (88.9%) and 10 (33.3%) in the intervention and comparison arms, respectively. Median hospital length of stay was significantly shorter in the intervention arm (10 days [IQR: 5-12] vs. 11.5 days [IQR: 8.5-17.75], P = 0.016).

All-cause mortality was two and thirteen in intervention and comparison groups, respectively. No serious adverse events were reported by the patients receiving sofosbuvir during the study.

Conclusion:

Among patients hospitalized with SARS-CoV-2, those who received sofosbuvir had more clinical recovery rate and had a shorter hospital length of stay than those who received usual antiviral agents in the study and these differences were statistically significant.