Adults with mild coronavirus disease 2019 (COVID-19) treated with fluvoxamine had a lower likelihood of clinical deterioration over 15 days when compared with placebo, according to study results published in JAMA.

This double-blind, fully remote, randomized clinical trial (ClinicalTrials.gov NCT04342663) addressed the critical question of how to prevent outpatients with mild COVID-19 from deteriorating to serious illness. Participants with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with COVID-19 symptom onset within 7 days were randomly assigned in a 1:1 ratio to receive either fluvoxamine or matching placebo. Fluvoxamine dosing was 50 mg at baseline until confirmation of eligibility, then increased to 100mg twice daily for 2 days, followed by 100 mg 3 times daily until day 15.

The primary outcome was clinical deterioration within 15 days, defined as participants meeting 2 criteria: 1) presence of dyspnea or hospitalization due to dyspnea or pneumonia and 2) oxygen saturation less than 92% on room air or supplemental oxygen requirement to maintain oxygen saturation of 92% or greater.

Of the 152 participants, 76% completed the trial. Demographic, clinical characteristics, and baseline oxygen saturation levels were similar between the 2 groups. The mean age was 46 years, 72% of participants were women, and 25% of participants were Black. While COVID-19 symptoms varied, the most common symptoms were fatigue (23%) and anosmia (29%).

There were 80 participants in the fluvoxamine group and 72 in the placebo group. Within 15 days of randomization, 8.3% participants in the placebo group experienced worsening conditions while participants in the fluvoxamine group did not experience clinical deterioration (absolute difference, 8.7%; 95% CI, 1.8-16.4%; P =.009).

Does Fluvoxamine Prevent Clinical Deterioration in Mild COVID-19?

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