EFFICACY OF FAVIPIRAVIR IN TREATING HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL

Dr. Shailendranath Biswas*, Professor Dr. S. K. Ballav, Dr. Sheikh Farid Uddin Ahmed, Dr. Mohammad Monir-Uz-Zaman, Dr. Utpal Chanda, Dr. Tahmida Khanom, Dr. Mohaiminul Haque, Dr. Ripon Roy and Dr. Avijit Kumar Mridha

ABSTRACT

Background: After the emergence of novel coronavirus disease (covid-19), several therapeutic agents of different mechanisms and groups have been tried and evaluated worldwide to reduce the toll of mortality and morbidity. But unfortunately, no such agent was proven beneficial in this regard. Methods: We conducted a double-blind, randomized, placebo-controlled trial of oral Favipiraivir in adults who got admitted into hospitals with features of respiratory tract infection and subsequently diagnosed as COVID-19 pneumonia by RT-PCR for COVID-19 test. Patients were randomly assigned to receive either Favipiravir (1600mg 12 hourly on day 1, followed by 600 mg 12 hourly daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome of the study was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only. Results: We enrolled a total of 100 patients in this study randomly after considering inclusion and exclusion criteria (with 60 assigned to Favipiravir and 40 to placebo). Among the participants who received Favipiravir had an average recovery time of 08 days (95% confidence interval [CI], 07 to 09), as compared with 12.5days (95% CI, 11 to 15) among those who received placebo. The in-hospital mortality was 1.66% with Favipiravir and 05% with placebo by day 15. Though there were some mild to moderate adverse drug reactions in both groups no serious adverse event was reported in any group. Conclusion: Our study demonstrates that Favipiravir is superior to placebo in hastening clinical recovery and reducing mortality in hospitalized mild to moderate COVID-19 disease.

Keywords: SARS-CoV-2, Coronavirus, Placebo, Recovery Time, Oxygen Saturation, Mechanical Ventilation.