Trial Sequential Analysis and Updated Meta-Analysis of Fluvoxamine on Clinical Deterioration in Adult Patients with Symptomatic COVID-19 Infection

Chia-Ling Yu, Andre F. Carvalho, Trevor Thompson, Tzu-Cheng Tsai, Ping-Tao Tseng, Chih-Wei Hsu, Yu-Kang Tu, Szu-Nian Yang, Tien-Wei Hsu (), Ta-Chuan Yeh () and Chih-Sung Liang
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Chia-Ling Yu: Department of Pharmacy, Chang-Gung Memorial Hospital, Linkou 244, Taiwan
Andre F. Carvalho: IMPACT (Innovation in Mental and Physical Health and Clinical Treatment) Strategic Research Centre, School of Medicine, Barwon Health, Deakin University, Geelong, VIC 3220, Australia
Trevor Thompson: Centre for Chronic Illness and Ageing, University of Greenwich, London SE10 9LS, UK
Tzu-Cheng Tsai: Department of Pharmacy, Chang-Gung Memorial Hospital, Linkou 244, Taiwan
Ping-Tao Tseng: Prospect Clinic for Otorhinolaryngology & Neurology, Kaohsiung 811, Taiwan
Chih-Wei Hsu: Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung 833, Taiwan
Yu-Kang Tu: Institute of Epidemiology & Preventive Medicine, College of Public Health, National Taiwan University, Taipei 106, Taiwan
Szu-Nian Yang: Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Centre, Taipei 112, Taiwan
Tien-Wei Hsu: Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung 813, Taiwan
Ta-Chuan Yeh: Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Centre, Taipei 114, Taiwan
Chih-Sung Liang: Department of Psychiatry, Beitou Branch, Tri-Service General Hospital, National Defense Medical Centre, Taipei 112, Taiwan

IJERPH, 2023, vol. 20, issue 5, 1-13

Abstract: Preliminary meta-analyses suggested that fluvoxamine was effective in treating COVID-19 infection. However, the reliability of this evidence has not yet been examined. MEDLINE, CENTRAL, EMBASE, PsycINFO, and ClinicalTrials.gov were searched to identify any randomized controlled trials (RCTs) from the inception of the databases to 5 February 2023. We used trial sequential analysis (TSA) to examine the reliability of the current existing evidence on the benefits of fluvoxamine on COVID-19 infection. The primary outcome was clinical deterioration, as defined in the original study (reported as odds ratio (OR), with 95% confidence intervals), and the secondary outcome was hospitalization. In the TSA, we used the relative risk reduction thresholds of 10, 20, and 30%. The updated meta-analysis of the five RCTs showed that fluvoxamine was not associated with lower odds of clinical deterioration when compared with a placebo (OR: 0.81; 0.59–1.11). The effect of fluvoxamine lay within the futility boundary (i.e., lack of effect) when using a 30% relative risk reduction threshold. The effect estimates lay between the superiority and futility boundary using the 10% and 20% threshold, and the required size of information was not reached for these two thresholds. The effect of fluvoxamine on the odds of hospitalization was not statistically significant (0.76; 0.56–1.03). In conclusion, there is no reliable evidence that fluvoxamine, when compared to a placebo, reduces the relative risk of clinical deterioration among adult patients with COVID-19 infection by 30%, and a relative risk reduction of 20% or 10% is still uncertain. The role of fluvoxamine as a COVID-19 treatment cannot be justified.

Keywords: fluvoxamine; COVID-19; meta-analysis; trial sequential analysis; deterioration (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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