Favipiravir is considered a potential treatment for COVID-19 due its efficacy against different viral infections. We aimed to explore the safety and efficacy of favipiravir in treatment of COVID-19 mild and moderate cases. It was randomized-controlled open-label interventional phase 3 clinical trial [NCT04349241]. 100 patients were recruited from 18th April till 18th May. 50 patients received favipiravir 3200 mg at day 1 followed by 600 mg twice (day 2–day 10). 50 patients received hydroxychloroquine 800 mg at day 1 followed by 200 mg twice (day 2–10) and oral oseltamivir 75 mg/12 h/day for 10 days. Patients were enrolled from Ain Shams University Hospital and Assiut University Hospital. Both arms were comparable as regards demographic characteristics and comorbidities. The average onset of SARS-CoV-2 PCR negativity was 8.1 and 8.3 days in HCQ-arm and favipiravir-arm respectively. 55.1% of those on HCQ-arm turned PCR negative at/or before 7th day from diagnosis compared to 48% in favipiravir-arm (p = 0.7). 4 patients in FVP arm developed transient transaminitis on the other hand heartburn and nausea were reported in about 20 patients in HCQ-arm. Only one patient in HCQ-arm died after developing acute myocarditis resulted in acute heart failure. Favipiravir is a safe effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.

After concerns were brought to the Editors' attention after publication, the raw data underlying the study were requested. The authors provided several versions of their dataset. Post-publication peer review confirmed that none of these versions fully recapitulates the results presented in the cohort background comparisons, casting doubt on the reliability of the data. Additional concerns were raised about the randomisation procedure, as the equal distribution of male and female patients is unlikely unless sex is a parameter considered during randomisation. However, based on the clarification provided by the authors, sex was not considered during this process. The Editors therefore no longer have confidence in the results and conclusions presented.

Background: Favipiravir is considered a potential treatment for COVID-19 due its efficacy against different viral infections. We aimed to explore the safety and efficacy of favipiravir in treatment of COVID-19 mild and moderate cases.Methods: A randomized-controlled open-label interventional phase 3 clinical trial [NCT04349241]. 100 patients were recruited from 18thApril till 18thMay. 50patients received favipiravir 3200mg at day1 followed by 600mg twice (day2-day10). 50patients received hydroxychloroquine 800mg at day1 followed by 200mg twice (day2- 10) and oral oseltamivir 75mg/12hour/day for 10 days. Patients were enrolled from Ain Shams University Hospital and Assiut University Hospital.Results: Both arms were comparable as regards demographic characteristics and comorbidities. The average onset of SARS-CoV-2 PCR negativity was 8.1 and 8.3 days in HCQ-arm and favipiravir-arm respectively. 55.1% of those on HCQ-arm turned PCR negative at/or before 7th day from diagnosis compared to 48% in favipiravir-arm (p=0.7). Four patients in FVP arm developed transient transaminitis on the other hand heartburn and nausea were reported in about 20 patients in HCQ-arm. Only one patient in HCQ-arm died after developing acute myocarditis resulted in acute heart failure. Conclusion: Favipiravir is a safe effective alternative for hydroxychloroquine in mild or moderate COVID-19 infected patients.