Role of favipiravir in the treatment of adult patients with moderate to severe COVID-19: a single-center, prospective, observational, sequential cohort study from Hungary

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ABSTRACT Background Preliminary data suggests that favipiravir might have a role in COVID-19 treatment. Our aim was to assess the role of favipiravir in the treatment of COVID-19. Methods A single-center, prospective, observational, sequential cohort study was performed among consecutive adults hospitalized with PCR-confirmed COVID-19 between March– July,2020. Patients were screened for inclusion by a priori criteria, and were included in the favipiravir cohort if SOC+FVP, or the non-favipiravir group if SOC±other antiviral medications without FVP were administered for >48 hours. Treatment allocation was done per national guidelines. For COVID-19 diagnosis and severity, ECDC and WHO definitions were utilized, and daily per protocol hospital follow-up was done. Primary composite end-point was disease progression (14-day all-cause death, need for mechanical ventilation, or immunomodulatory therapy). For statistical comparison, Fisher’s exact test and Mann– Whitney U-test were used. Results In all, 75 patients were included per cohort. In the FVP cohort, chronic heart disease (36/75, 48.0% vs. 16/75, 21.3%, p<0.01) and diabetes mellitus (23/75, 30.7% vs. 10/75, 13.3%, p<0.01) were more prevalent, hospital LOS (18.5±15.5 days vs. 13.0±8.5 days, p<0.01) was higher. Disease progression (17/75, 22.7% vs. 10/75, 13.3%, p=0.13), 14-day all-cause death (9/75, 12.0% vs. 10/75, 13.3%, p=0.8) and need for mechanical ventillation (8/75, 10.7% vs. 4/75, 5.3%, p=0.22) were similar between groups. Immunomodulatory therapies were administered frequently among patients receiving FVP (10/75, 13.3% vs. 1/75, 1.3%, p<0.01). Conclusions In this study, favipiravir did not seem to affect disease progression. Further data are needed to position this drug among the anti-SARS-CoV-2 armamentarium.

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