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>>> Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19


November 12, 2020


https://jamanetwork.com/journals/jama/fullarticle/2773108


A Randomized Clinical Trial

Eric J. Lenze, MD1; Caline Mattar, MD2; Charles F. Zorumski, MD1; et alAngela Stevens, BA1; Julie Schweiger1; Ginger E. Nicol, MD1; J. Philip Miller, AB3; Lei Yang, MPH, MSIS1; Michael Yingling, MS1; Michael S. Avidan, MBBCh4; Angela M. Reiersen, MD, MPE1
Author Affiliations Article Information

JAMA. 2020;324(22):2292-2300. doi:10.1001/jama.2020.22760


Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19

Key Points

Question

Does fluvoxamine, a selective serotonin reuptake inhibitor and s-1 receptor agonist, prevent clinical deterioration in outpatients with acute coronavirus disease 2019 (COVID-19)?

Findings In this randomized trial that included 152 adult outpatients with confirmed COVID-19 and symptom onset within 7 days, clinical deterioration occurred in 0 patients treated with fluvoxamine vs 6 (8.3%) patients treated with placebo over 15 days, a difference that was statistically significant.

Meaning In this preliminary study, adult outpatients with symptomatic COVID-19 treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days; however, determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.

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 s-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.

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