J Med Virol. 2021 Aug 11. doi: 10.1002/jmv.27264. Online ahead of print.
BACKGROUND: Only a few treatments are approved for COVID-19 infections, with continuous debate about their clinical impact. Repurposing antiviral treatments might prove the fastest way to identify effective therapy.
OBJECTIVES: This trial aimed to evaluate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or ravidasvir (RDV) added to standard care (SOC) for patients with moderate and severe COVID-19 infection.
METHOD: Multicentre parallel randomized controlled open lapel trial. One-hundred-twenty eligible patients with moderate and severe COVID-19 infection were randomized to one of the study arms.
INTERVENTION: Ten days treatment with SOF plus DCV or RDV in addition to the standard of care compared to SOC. Follow up 7 days.
MAIN OUTCOME MEASURES: Sum of the counted symptoms at 7 & 10 days, mean change in oxygen saturation level, viral negativity and rate of ICU admission.
RESULTS: Compared to SOC, SOF-DCV group experienced a significantly lower sum of the counted symptoms (fever, headache, generalized aches, or respiratory distress) combined with no evidence of deterioration (ICU admission and mechanical ventilation) on days 7 and 10 of treatment. Oxygen saturation also significantly improved among SOF-DCV group compared to SOC starting from day 4. The study also showed positive trends regarding the efficacy of SOF-DCV with lower incidence of mortality. On the other hand, adding SOF-RDV to SOC did not show significant improvements in endpoints.
CONCLUSION: The results support the efficacy and safety of SOF-DCV as an add-on to SOC for treatment of moderate to severe COVID-19 infections. This article is protected by copyright. All rights reserved.