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, 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).

Keywords: COVID-19; Community treatment center; Fluvoxamine; Risk factor; SARS-CoV-2.

Conflict of interest statement

SOL and SHC are editorial board of Infect Chemother; however, they did not involve in the peer reviewer selection, evaluation, and decision process of this article. Otherwise, no potential conflicts of interest relevant to this article was reported.

Copyright © 2022 by The Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, and The Korean Society for AIDS.

Figures

Figure 1. Enrollment and patient flow.
Figure 1. Enrollment and patient flow.
aOf the three patients, one gave a false positive SARS-CoV-2 positive result followed by repeated negative results, and the remaining two patients with negative SARS-CoV-2 results were admitted to the CTC to take care of their children with COVID-19. bOf the five patients, two were referred to a hospital because of poor oral intake, one was referred due to a burn wound, and one due to claustrophobia. cOf the six patients, two had chronic liver disease, three had psychiatric diseases, and one had a cognitive disorder. CTC, community treatment center; COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.
Figure 2. Time to clinical deterioration in…
Figure 2. Time to clinical deterioration in the fluvoxamine and placebo groups (log-rank test).
The median observation time for both groups were 10 days (interquartile range, 10 - 10 days). Study 0 indicates the day of randomization.

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