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0 0.5 1 1.5 2+ Progression 0% Improvement Relative Risk Progression, PP 34% Time to progression 13% c19early.org/f Seo et al. Fluvoxamine for COVID-19 RCT EARLY TREATMENT Is early treatment with fluvoxamine beneficial for COVID-19? RCT 52 patients in South Korea (January - February 2021) Trial underpowered to detect differences Seo et al., Infection & Chemotherapy, doi:10.3947/ic.2021.0142 Favors fluvoxamine Favors control
Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial
Seo et al., Infection & Chemotherapy, doi:10.3947/ic.2021.0142
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
Mar 2022   Source   PDF  
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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.
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Abstract: Infect Chemother. 2022 Mar;54(1):e11 https://doi.org/10.3947/ic.2021.0142 pISSN 2093-2340·eISSN 2092-6448 Fluvoxamine Treatment of Patients with Symptomatic COVID-19 in a Community Treatment Center: A Preliminary Result of Randomized Controlled Trial Original Article Received: Dec 21, 2021 Accepted: Feb 19, 2022 Published online: Mar 3, 2022 n o i is Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 2 Division of Infectious Diseases, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea 3 Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 4 Department of Family Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea 1 Corresponding Author: 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. Tel: +82-2-3010-3306 Fax: +82-3010-3306 Email: drchong@amc.seoul.kr v o r P Copyright © 2022 by The Korean Society of Infectious Diseases, Korean Society for Antimicrobial Therapy, and The Korean Society for AIDS This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https:// creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ORCID iDs Hyeonji Seo https://orcid.org/0000-0001-6659-6853 Haein Kim https://orcid.org/0000-0003-2002-1098 Seongman Bae https://orcid.org/0000-0001-6375-3657 Seonghee Park https://orcid.org/0000-0003-2902-8341 Hyemin Chung https://orcid.org/0000-0002-4447-975X Heung-sup Sung https://orcid.org/0000-0002-6062-4451 https://icjournal.org l a 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 l a n o ABSTRACT i is 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 them..
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