Early COVID-19 patients who were given fluvoxamine were significantly less likely to deteriorate or require hospitalization, according to this US-based clinical trial.

Key Messages

This randomized clinical trial, which took place in the US, was designed to determine the ability of fluvoxamine to reduce the severity of COVID-19 and the likelihood of deterioration in patients with mild symptoms.

152 adult COVID-19 patients were included in the trial. None was hospitalized and all had oxygen saturation levels of > 92%. 80 patients were given 100mg of fluvoxamine three times a day and 72 were given a placebo.

In this study, clinical deterioration was defined as shortness of breath or hospitalization for shortness of breath and a decrease in oxygen saturation levels to below 92%.

None of the 80 fluvoxamine-treated patients deteriorated whereas six of the 72 patients in the placebo group deteriorated.

In addition, there were six serious adverse events and 12 non-serious adverse events in the placebo group but only one serious adverse event and 11 non-serious adverse events in the fluvoxamine group.

The results of this preliminary trial suggest that fluvoxamine has the potential to treat early COVID-19 and to reduce deterioration and hospitalization.

JAMA

Publication Date: November 12, 2020
Peer Reviewed: Yes
Publication Type: Original | Clinical Prospective
DOI: https://www.doi.org/10.1001/jama.2020.22760

Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19 – A Randomized Clinical Trial

Eric J. Lenze, Caline Mattar, Charles F. Zorumski, Angela Stevens, Julie Schweiger, Ginger E. Nicol, J. Philip Miller, Lei Yang, Michael Yingling, Michael S. Avidan, Angela M. Reiersen

Abstract

Importance Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the σ-1 receptor, which regulates cytokine production.
Objective To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.
Design, Setting, and Participants Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.
Interventions Participants were randomly assigned to receive 100 mg of fluvoxamine (n = 80) or placebo (n = 72) 3 times daily for 15 days.
Main Outcomes and Measures 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.
Results Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.
Conclusions and Relevance In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.