New study finds fluvoxamine ineffective for mild to moderate COVID-19 in outpatients

A new U.S. study has evaluated the efficacy of fluvoxamine for the treatment of mild to moderate COVID-19 in outpatients. The study was undertaken because of the uncertainty in the effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild to moderate symptomatic COVID-19.1 Study participants were randomized to self-administer low-dose fluvoxamine (50 mg twice daily) for 10 days or placebo. The 50 mg twice-daily dosage was selected for better tolerability and adherence compared with the 100 mg twice daily or three times daily dose used in earlier COVID-19 trials. The study was conducted during the time periods when the Delta variant and early Omicron subvariants dominated.1 The primary outcome was time to sustained recovery (defined as the third day of 3 consecutive days without symptoms). The seven secondary outcomes included a composite outcome of hospitalization, urgent care visit, emergency department visit or death through day 28.1 Of the 1,331 participants, the median age was 47 years, 57% were women, and 67% had received two or more doses of a SARS-CoV-2 vaccine. High-risk comorbidities were common (36.4% had a body mass index > 30, 24.4% had hypertension, 13.2% had asthma, 9.2% had diabetes). The trial was completed by 1,288 participants (674 in the fluvoxamine group, 614 in the placebo group).1 Results showed the following: Primary outcome: The median time to sustained recovery was 12 days in the fluvoxamine group and 13 days in the placebo group (no statistical evidence of a treatment benefit). Composite outcome: 26 participants (3.9%) in the fluvoxamine group were hospitalized, had an urgent care or emergency department visit, or died, compared with 23 participants (3.8%) in the placebo group (no treatment benefit). One participant in the fluvoxamine group and two participants in the placebo group were hospitalized; no deaths occurred in either group. Adverse events were similar, but uncommon, in both groups.1 In this large study of 1,288 outpatients with mild to moderate COVID-19, treatment with fluvoxamine 50 mg twice daily for 10 days did not improve time to sustained recovery compared with placebo. The investigators conclude that these findings do not support the use of fluvoxamine at this dose and duration for outpatients with mild to moderate COVID-19.1 An accompanying editorial examines the question of whether fluvoxamine has a role in the treatment of mild to moderate COVID-19 during this phase of the pandemic. The editorial acknowledges that earlier trials evaluating fluvoxamine for the treatment of COVID-19 have shown variable results. The STOP COVID and TOGETHER trials reported benefits, but the STOP COVID 2 and COVID-OUT trials did not. The editorial points out that interpretation of these trial results is complicated by their differences in location, predominant circulating variants, baseline risks of progression in the study populations and vaccination rates. The studies also used different fluvoxamine dosage regimens and evaluated different clinical outcomes.2 The editorial concludes that despite the difficulties in appraising studies conducted during different periods of the pandemic, the totality of evidence for fluvoxamine does not support its current use for treatment of mild to moderate COVID-19 in outpatients. This is particularly true now that antiviral treatment alternatives (e.g., nirmatrelvir–ritonavir, remdesivir) are available, and which have stronger supporting evidence of efficacy.2 References 1. McCarthy MW, Naggie S, Boulware DR, et al. Effect of fluvoxamine vs placebo on time to sustained recovery in outpatients with mild to moderate COVID-19. A randomized clinical trial. JAMA 2023; Published online January 12, 2023. (accessed January 17, 2023). 2. Bhimraj A, Gallagher JC. Lack of benefit of fluvoxamine for COVID-19. JAMA 2023; Published online January 12, 2023. (accessed January 17, 2023).

New study finds fluvoxamine ineffective for mild to moderate COVID-19 in outpatients

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