Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial
Seo et al.
, Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary..
, Infection & Chemotherapy, doi:10.3947/ic.2021.0142
Early terminated RCT with 52 COVID+ patients in South Korea, showing no significant difference in progression with fluvoxamine treatment. There were only 2 events in each arm, and only one event for fluvoxamine in PP analysis. The trial was terminated early because the treatment center closed. 100mg fluvoxamine bid for 10 days.
risk of progression, no change, RR 1.00, p = 1.00, treatment 2 of 26 (7.7%), control 2 of 26 (7.7%).
risk of progression, 34.2% lower, RR 0.66, p = 1.00, treatment 1 of 19 (5.3%), control 2 of 25 (8.0%), NNT 37, PP.
time to progression, 13.3% lower, relative time 0.87, p = 0.16, treatment mean 6.5 (±0.7) n=26, control mean 7.5 (±3.5) n=26.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Seo et al., 3 Mar 2022, Single Blind Randomized Controlled Trial, placebo-controlled, South Korea, peer-reviewed, median age 53.5, 14 authors, study period 15 January, 2021 - 19 February, 2021.
Abstract: Infect Chemother. 2022 Mar;54(1):e11
pISSN 2093-2340·eISSN 2092-6448
Fluvoxamine Treatment of Patients
with Symptomatic COVID-19 in a
Community Treatment Center:
A Preliminary Result of Randomized
Received: Dec 21, 2021
Accepted: Feb 19, 2022
Published online: Mar 3, 2022
Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul,
Division of Infectious Diseases, Department of Internal Medicine, Hallym University Sacred Heart Hospital,
Hallym University College of Medicine, Anyang, Korea
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul,
Department of Family Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Yong Pil Chong, MD, PhD
Department of Infectious Diseases, Asan
Medical Center, University of Ulsan College of
Medicine, 88, Olympic-ro 43-gil, Songpa-gu,
Seoul 05505, Korea.
Copyright © 2022 by The Korean Society
of Infectious Diseases, Korean Society for
Antimicrobial Therapy, and The Korean Society
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Hyeonji Seo 1,2, Haein Kim 1, Seongman Bae 1, Seonghee Park 1,
Hyemin Chung 1, Heung-sup Sung 3, Jiwon Jung 1, Min Jae Kim 1,
Sung-Han Kim 1, Sang-Oh Lee 1, Sang-Ho Choi 1, Yang Soo Kim 1,
Ki Young Son 4, and Yong Pil Chong 1
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 timepolymerase 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
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