Fluvoxamine of little benefit in mild-to-moderate COVID-19

The use of fluvoxamine for outpatient treatment of mild-to-moderate COVID-19 falls short of reducing the duration of symptoms, as shown in the ACTIV-6 study.

ACTIV-6 included 1,175 participants (median age 50 years, 65.8 percent women, 72.7 percent White) at least 30 years old who had confirmed SARS-CoV-2 infection and at least two acute COVID-19 symptoms for not more than 7 days. These participants were randomly assigned to receive fluvoxamine 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n=589) or placebo (n=586).

Among the participants, the most common comorbidities were obesity (36.1 percent) and hypertension (25.8 percent). Most participants (76.8 percent) reported receiving at least 2 SARS-CoV-2 vaccine doses.

The primary outcome of time to sustained recovery (defined as at least 3 consecutive days without symptoms) was comparable between the fluvoxamine and placebo groups (adjusted hazard ratio [HR], 0.99, 95 percent credible interval, 0.89–1.09; p=0.40). The unadjusted median time to sustained recovery was 10 days in both treatment groups.

Likewise, there were no significant between-group differences seen in secondary outcomes. For example, reported health care use events (a priori defined as death, hospitalization, or emergency department/urgent care visit) were 14 in the fluvoxamine group and 21 in the placebo group (HR, 0.6, 95 percent credible interval, 0.27–1.21; p=0.86). None of the participants in the study died, although there were seven serious adverse events reported in six participants, including two in the fluvoxamine group and four in the placebo group.