Safety and Efficacy of Sofosbuvir in Hospitalized Adult Patients with SARS-CoV-2: A Preliminary Report

Background: Despite the worldwide spread of the SARS-CoV-2, an effective specific antiviral treatment for COVID-19 is yet to be identified. Here we report the preliminary results of the phase II open-label clinical trial of the safety and efficacy of Sofosbuvir as antiviral therapy among hospitalized adult patients with SARS-CoV-2.Methods: The study was randomized, controlled, open-label phase II clinical trial in hospitalized adult patients with SARS-CoV-2. 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, sustained for at least 72 hours within 14 days since the initiation of antiviral therapy. 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.Findings: From April to Sep 2020, ninety patients were recruited in the study. Thirty-three patients were excluded before enrollment. 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%) in the intervention arm and 10 (33.3%) in the comparison arm. The intervention arm had a significantly shorter median hospital length of stay [10days (IQR 5-12)] than the comparison group [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.Interpretation: Among adult 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. Trial Registration: (Iranian Registry of Clinical Trials Number, IRCT20200328046882N1)Funding Statement: Funding by Deputy of Research in Shahid Beheshti University of Medical Sciences.Declaration of Interests: None to declareEthics Approval Statement: The study was approved in the institutional review boards of Shahid Beheshti University of Medical Science (IR.SBMU.REC.1399.001).