Efficacy of combination therapy of fluvoxamine and favipiravir vs favipiravir monotherapy to prevent severe COVID-19 among mild to moderate COVID-19 patients: Open-label randomized controlled trial (EFFaCo study)
Taweegrit Siripongboonsitti, Teerapat Ungtrakul, Kriangkrai Tawinprai, Tararin Nimmol, Mullika Buttakosa, Gaidganok Sornsamdang, Tanadul Jarrusrojwuttikul, Phumin Silapant, Nithi Mahanonda
Abstract
BackgroundFluvoxamine (FVX) is an antidepressant proposed to its immunomodulatory effects in preventing deterioration in mild and moderate COVID-19.MethodsAn open-label, 1:1 randomized controlled trial was assigned either combination therapy 50 mg twice daily of FVX for 10 days and favipiravir (FPV) or FPV alone to assess the efficacy in preventing disease progression in mild to moderate COVID-19 on the fifth day.Results134 mild COVID-19 patients received FPV and 132 received FVX/FPV, 31 moderate COVID-19 patients received FPV/Dexamethasone (FPV/Dex), and 30 received FVX/FPV/Dexamethasone (FVX/FPV/Dex). The intention-to-treat (ITT) analysis showed no difference of no clinical deterioration on the fifth day in both mild COVID-19 (100% in FPV vs. 97% in FVX/FPV) and moderate COVID-19 (83.9% in FPV/Dex vs. 86.7% in FVX/FPV/Dex). However, there was a low rate of oxygen supplemental, hospitalization, or intensive care in both groups and zero death in all groups. No significant difference in oxygen supplemental, hospitalization, radiological, virological, or biochemical outcomes, and the immunomodulatory effect was observed between the group.ConclusionThe combined fluvoxamine treatment did not add benefit in preventing deterioration in mild-to-moderate COVID-19 patients without the immunomodulatory effect observed, although it demonstrated low hospitalization rates, oxygen supplemental, intensive care needed, and zero mortality.Trial RegistrationThai clinical trials registry (TCTR) no. 20210615002