fficacy and safety of Sofosbuvir plus Daclatasvir or Ravidasvir in patients with COVID-19, A Randomized Controlled Trial

• Published in: Journal of Medical Virology 2021
• Main Authors: abbass, Sherif, Salama, Mohsen, Salman, Tary, Sabry, Alyaa, Abdel-Razek, Wael, Kamal, Ehab, Helmy, Sherin, Abdelgwad, Ahmed, Sakr, Neamt, Elgazzar, Mohamed, Mohamed, Einar, Mahmoud Farouk, Saif, Mounir, Ismail Shehab, El-hosieny, Eman, Mansour, Mai, Mahdi, Doaa, El-Sayed, Tharwa, Mostafa Salah, Elrouby, Ola, Waked, Imam
• Format: Web Resource
• Language: English
• DOI: 10.1002/jmv.27264

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.