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).
The placebo group experienced more serious adverse events (6 vs 1) and other adverse events (12 vs 11) compared with the fluvoxamine group. Participants in the placebo group also experienced more pneumonia and gastrointestinal symptoms.
Limitations of this study included a small sample size, a single geographic area, and a short follow-up duration. “Determination of clinical efficacy would require larger randomized trials with more definitive outcome measures,” concluded the researchers.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Lenze EJ, Mattar C, Zorumski CF, et al. Fluvoxamine vs placebo and clinical deterioration in outpatients with symptomatic COVID-19: a randomized clinical trial. JAMA. Published online November 12, 2020. doi: 10.1001/jama.2020.22760