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, MD Yong Pil Chong
Infection & Chemotherapy, doi:10.3947/ic.2021.0142
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 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.
SUPPLEMENTARY MATERIALS
Supplementary document 1
Supplementary Table 1 Primary and secondary outcomes in the per-protocol analysis
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Supplementary Table 2 Baseline and clinical characteristics of patients admitted to CTC according to the outcome Click here to view Supplementary Table 3 Results of analyses of risk factors for transfer to hospital due to clinical deterioration Click here to view
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