Safety and efficacy of favipiravir versus hydroxychloroquine in management of COVID-19: A randomised controlled trial

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 HCQarm. 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. At the end of 2019, the entire world saw the first appearance of the coronavirus disease 2019 (COVID-19) 1 . By March 2020, it was declared a pandemic by the World Health Organization (WHO). Globally, more than 83 million cases of COVID-19 and more than 1.5 million deaths have been reported so far 2, 3 . The first case registered in Egypt was in February 2020, and, since then, the number has been increasing. By early July 2020, nearly 1.5 hundred thousand confirmed cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and about 8000 deaths were reported by the Ministry of Health (MoH) 4 . In Egypt, the curve of new cases prompted an investigation into the different treatment options to find the most effective and safe choice for COVID-19 patients. Favipiravir (FPV) is one of the potential options according to a Chinese study, considering its past history of efficacy against viral influenza 5 . Being a novel RNA-dependent RNA polymerase (RdRp) inhibitor, FPV has also shown efficacy against the Ebola virus 6, 7 . FVP, known as Avigan, is a pyrazine derivative and guanine analogue that acts as a chain termination tool and prevents RNA elongation. Favipiravir demonstrated anti-viral activities against a broad array of RNA viruses, including arenaviruses, bunyaviruses, and filoviruses 8 . In Japan, favipiravir has been approved for influenza A resistant to neuraminidase inhibitors 9 . Also, an expert consensus group in China suggested that chloroquine improved lung imaging and shortened the disease course 10 . However, a number of additional reports have since shown no positive..