Treatment of mild, symptomatic coronavirus disease 2019 (COVID-19) with fluvoxamine may reduce the risk of clinical deterioration, according to the findings of a double-blind, randomized clinical trial conducted in the greater St Louis metropolitan area.
The study, which was fully remote and contactless, aimed to evaluate whether early treatment with fluvoxamine, a selective serotonin reuptake inhibitor and σ-1 receptor agonist, reduced the likelihood of clinical deterioration and disease severity in patients with mild COVID-19 illness. Those enrolled in the study had confirmed severe acute respiratory syndrome coronavirus 2 infection, were symptomatic within 7 days of the first dose of study drug, and had an oxygen saturation of at least 92%.
Participants were randomized to receive either fluvoxamine 100mg (n=80) or placebo (n=72) 3 times daily for a total of 15 days. “The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater,” the authors explained.
The average (SD) age of patients included in the study was 46 (13) years and 72% (n=109) were women; 76% (n=115) of patients completed the trial. The authors reported that none of the 80 fluvoxamine-treated patients experienced clinical deterioration during the study period compared with 6 of the 72 patients in the placebo group (absolute difference: 8.7%; [95% CI, 1.8-16.4] from survival analysis; log-rank P =.009).
Findings also revealed fluvoxamine was generally well tolerated. One serious and 11 other adverse events occurred in the fluvoxamine group compared with 6 serious and 12 other adverse events in the placebo group.
Based on their findings, the authors concluded that fluvoxamine may potentially benefit patients with mild, symptomatic COVID-19; however, they noted that larger randomized trials were needed to confirm clinical efficacy.
Disclosure: Multiple authors declared conflicts of interest. Please refer to the original article for a full list of disclosures.
1. Lenze EJ, Mattar C, Zorumski CF. Fluvoxamine vs placebo and clinical deterioration in outpatients with symptomatic COVID-19: a randomized clinical trial [published online November 12]. JAMA. 2020. doi: 10.1001/jama.2020.22760.