Fluvoxamine for Adults With Mild to Moderate COVID-19

Summary

This clinical trial aims to determine if fluvoxamine, a selective serotonin reuptake inhibitor with high affinity for the sigma-1 receptor, can be used in mild to moderate COVID-19 to prevent the progression to severe COVID-19. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder and has a potential for immune modulation as a sigma-1 receptor agonist. The investigational use of fluvoxamine for the treatment of COVID-19 is approved by the South Korean Ministry of Food and Drug Safety. This study is performed fully-remotely at COVID-19 community treatment centers, temporary facilities in Seoul, Korea, to accommodate and monitor asymptomatic to moderately symptomatic case-patients who do not require hospital admission.

Timeline

Start

2021-01-16

Primary completion

2021-05-31

Completion

2021-07-31

Outcome

Missed primary endpoint

Stopped: “Closure of main community treatment center”

paper Clinical deterioration occurred in 2 of 26 patients in each group (P >0.99). PMID 35384422 ↗

paper there was no significant differences in clinical deterioration between patients treated with fluvoxamine and placebo PMID 35384422 ↗

Publications

• Seo H, Kim H, Bae S, Park S, Chung H, Sung HS, Jung J, Kim MJ, Kim SH, Lee SO, Choi SH, Kim YS, Son KY, Chong YP. Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial. Infect Chemother. 2022 Mar;54(1):102-113. doi: 10.3947/ic.2021.0142.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluvoxamine	Unknown	100 mg	Oral

Indications