Fluvoxamine is not effective for improving time to recovery in adults with mild to moderate COVID-19

Reference

McCarthy MW, Naggie S, Boulware DR, et al, for the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group. Effect of fluvoxamine vs placebo on time to sustained recovery in outpatients with mild to moderate COVID-19. A randomized clinical trial. JAMA 2023;329(4):296-305.

Synopsis

These investigators identified adults, 30 years or older, with SARS-CoV-2 infection confirmed by polymerase chain reaction or antigen testing. Eligibility criteria included having a confirmed infection for 10 days or less and experiencing 2 or more typical COVID-19 symptoms for 7 days or less from time of consent. Receipt of a vaccine was not an exclusion criterion. Enrollment occurred between August 6, 2021, and May 27, 2022. Study participants (N = 1331), as part of a trial evaluating multiple interventions (ie, ivermectin and inhaled fluticasone, as well as fluvoxamine), randomly received (concealed allocation) fluvoxamine, 50 mg twice daily for 10 days, or matching placebo. Study participants, masked to treatment group assignment, self-assessed outcomes daily for 14 days with follow-up evaluations occurring at days 28 and 90. Complete data at trial completion were available for 96.8% of participants. Using intention-to-treat analysis, no significant differences occurred in the median time to sustained recovery (defined as at least 3 days with no symptoms) between the intervention group and the control group (12 vs 13 days, respectively). On secondary analysis, no significant group difference occurred in the composite outcome of hospitalization, urgent care or emergency department visit, or death (3.9% for the fluvoxamine group vs 3.8% for the placebo group). There was no evidence of a treatment effect for vaccine status, timing of symptom onset, severity of symptoms, age, sex, body mass index, or calendar time.