Add-on fluvoxamine of no benefit in mild-to-moderate COVID-19

In the treatment of patients with mild-to-moderate COVID-19, adding fluvoxamine to favipiravir does not appear to prevent disease progression or improve certain outcomes, according to the results of an open-label study.

The study included 266 patients with mild COVID-19 and 61 with moderate COVID-19. They were randomly assigned to receive 50 mg twice daily of fluvoxamine for 10 days and favipiravir (FVX/FPV) or favipiravir alone (FPV). The primary endpoint was no clinical deterioration, as defined by the World Health Organization (WHO) clinical progression scale, on day 5.

In the mild cohort, 134 patients received FPV and 132 received FVX/FPV. In the moderate cohort, 31 patients received FPV/dexamethasone (FPV/Dex) and 30 received FVX/FPV/Dex. No difference in the proportion of patients without clinical deterioration on day 5 in both the mild cohort (100 percent in the FPV group vs 97 percent in the FVX/FPV group) and in the moderate cohort (83.9 percent in the FPV/Dex group vs 86.7 percent in the FVX/FPV/Dex group).

Oxygen supplemental, hospitalization, and intensive care rates were low across all patient groups. Furthermore, there were no significant between-group differences observed in oxygen supplemental, hospitalization, radiological, virological, or biochemical outcomes. None of the patients died during the study.

The findings suggest that there is no benefit to using add-on fluvoxamine in mild-to-moderate COVID-19 patients in terms of improving the radiological, virological, inflammatory marker changes, or immunomodulatory outcomes.