Fluvoxamine strikes out in mild-to-moderate COVID-19

Treatment with fluvoxamine does not appear to improve outcomes in patients with mild-to-moderate COVID-19, with a study showing that the drug does not shorten symptom duration as compared with placebo.

The analysis included 1,331 patients (median age 47 years, 57 percent women, 67 percent received ≥2 doses of a SARS-CoV-2 vaccine) participating in the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) platform randomized clinical trial. The patients had test-confirmed SARS-CoV-2 infection and ≥2 symptoms of acute COVID-19 for ≤7 days. They were randomized to receive 50 mg of fluvoxamine or placebo, administered twice daily for 10 days.

Of the patients, 1,288 completed the trial (674 in the fluvoxamine group and 614 in the placebo group). The primary outcome of time to sustained recovery (defined as the third day of three consecutive days without symptoms) did not significantly differ in the two treatment groups: a median of 12 days with fluvoxamine and a median of 13 days with placebo group (hazard ratio [HR], 0.96, 95 percent credible interval [CrI], 0.86–1.06; p=0.21).

Results were also similar for the composite outcome of hospitalization, urgent care visit, emergency department visit, or death through day 28. The outcome occurred in 26 patients in the fluvoxamine group and in 23 patients in the placebo group (3.9 percent vs 3.8 percent; HR, 1.1, 95 percent CrI, 0.5–1.8; p=0.35).

One patient on fluvoxamine and two patients on placebo were hospitalized. There were no deaths recorded in either group. In terms of safety, adverse events were uncommon in the two treatment groups.