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

SZABO, B. G.; LENART, K. S.; PETRIK, B.; GASPAR, Z.; BALOGH, Z.; BANYAI, Z.; BANYASZ, E.; BUDAI, J.; CZEL, E.; FRIED, K.; HANUSKA, A.; KISS-DALA, N.; LORINCZI, C.; NEMESI, K.; KADAR, J.; NAGY, E. L.; OSVALD, A.; PETROVICZ, E.; RICZU, A.; SZANKA, J.; SZATHMARY, B.; SZOMBATI, A.; TOTH, S.; VARNAI, Z.; WOLLER, O.; SZLAVIK, J.; LAKATOS, B.

Background: Preliminary data suggests that favipiravir (FVP) might have a role in COVID-19 treatment. 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 standard-of-care (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.