Fluvoxamine treatment of patients with symptomatic COVID-19 in a community treatment center in Korea

Key Messages

This small clinical trial found no significant difference in clinical deterioration in 52 symptomatic mild to moderate COVID-19 patients treated with either fluvoxamine or a placebo. The clinical deterioration rate was approximately 7.7% in both groups.

Fluvoxamine treatment dose was 50 mg on the first day of treatment, followed by 100 mg twice a day until discharge from the treatment center (approx. 10 days) and 50 mg twice during the day after discharge.

Fluvoxamine was well tolerated, with no significant differences in adverse events between the fluvoxamine and the placebo group. No serious adverse events were noted.

The authors acknowledge that the number of patients treated was too small to conclusively demonstrate fluvoxamine’s efficacy, and larger trials are needed.

Infection & Chemotherapy

Publication Date: March 3, 2022
Peer Reviewed: Yes
Publication Type: Original | Clinical Prospective
DOI: https://www.doi.org/10.3947/ic.2021.0142

Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial

Hyeonji Seo, Haein Kim, Seongman Bae, Seonghee Park, Hyemin Chung, Heung-sup Sung, Jiwon Jung, Min Jae Kim, Sung-Han Kim, Sang-Oh Lee, Sang-Ho Choi, Yang Soo Kim, Ki Young Son, Yong Pil Chong

Abstract

Background:
This study aimed to evaluate whether fluvoxamine reduces clinical deterioration in adult patients with mild to moderate coronavirus disease 2019 (COVID-19), and to identify risk factors for clinical deterioration in patients admitted to a community treatment center (CTC).

Materials and methods:
A randomized, placebo-controlled trial was conducted in a CTC, in Seoul, Korea from January 15, 2021, to February 19, 2021. Symptomatic adult patients with positive results of severe acute respiratory syndrome coronavirus 2 real time-polymerase chain reaction within 3 days of randomization were assigned at random to receive 100 mg of fluvoxamine or placebo twice daily for 10 days. The primary outcome was clinical deterioration defined by any of the following criteria: oxygen requirement to keep oxygen saturation over 94.0%, aggravation of pneumonia with dyspnea, or World Health Organization clinical progression scale 4 or greater.

Results:
Of 52 randomized participants [median (interquartile range) age, 53.5 (43.3 – 60.0) years; 31 (60.0%) men], 44 (85.0%) completed the trial. Clinical deterioration occurred in 2 of 26 patients in each group (P >0.99). There were no serious adverse events in either group. Clinical deterioration occurred in 15 (6.0%) of 271 patients admitted to the CTC, and all of them were transferred to a hospital. In multivariate analysis, age between 55 and 64, fever and pneumonia at admission were independent risk factors for clinical deterioration.

Conclusion:
In this study of adult patients with symptomatic COVID-19 who were admitted to the CTC, there was no significant differences in clinical deterioration between patients treated with fluvoxamine and placebo (ClinicalTrials.gov Identifier: NCT04711863).