Evaluating fluvoxamine for the outpatient treatment of COVID‐19: A systematic review and meta‐analysis
Jiawen Deng, Myron Moskalyk, Qi Kang Zuo, Cristian Garcia, Umaima Abbas, Harikrishnaa Ba Ramaraju, Daniel Rayner, Ye‐jean Park, Kiyan Heybati, Fangwen Zhou, Simran Lohit
Reviews in Medical Virology, doi:10.1002/rmv.2501
This systematic review and meta-analysis of randomised controlled trials (RCTs) aimed to evaluate the efficacy, safety, and tolerability of fluvoxamine for the outpatient management of COVID-19. We conducted this review in accordance with the PRISMA 2020 guidelines. Literature searches were conducted in MED-LINE, EMBASE, International Pharmaceutical Abstracts, CINAHL, Web of Science, and CENTRAL up to 14 September 2023. Outcomes included incidence of hospitalisation, healthcare utilization (emergency room visits and/or hospitalisation), mortality, supplemental oxygen and mechanical ventilation requirements, serious adverse events (SAEs) and non-adherence. Fluvoxamine 100 mg twice a day was associated with reductions in the risk of hospitalisation (risk ratio [RR] 0.75, 95% confidence interval [CI] 0.58-0.97; I 2 = 0%) and reductions in the risk of healthcare utilization (RR 0.68, 95% CI 0.53-0.86; I 2 = 0%). While no increased SAEs were observed, fluvoxamine 100 mg twice a day was associated with higher treatment non-adherence compared to placebo (RR 1.61, 95% CI 1.22-2.14; I 2 = 53%). In subgroup analyses, fluvoxamine reduced healthcare utilization in outpatients with BMI ≥30 kg/m 2 , but not in those with lower BMIs. While fluvoxamine offers potential benefits in reducing healthcare utilization, its efficacy may be most pronounced in high-risk patient populations. The observed non-adherence rates highlight the need for better patient education and counselling. Future investigations should reassess trial endpoints to include outcomes relating to post-COVID sequelaes. Registration: This review was prospectively registered on PROSPERO (CRD42023463829).
| Study limitations The major limitation of this study is the potential presence of smallstudy effects for the outcome of hospitalisation and the requirement Note: GRADE Working Group quality of evidence rating. 28 High quality: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: We are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: Our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low quality: We have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. Abbreviations: CI, Confidence Interval; RR, Risk Ratio. a The absolute risk in the intervention group (and its 95% confidence interval) is based on the baseline risk in the control group and the relative effect of the intervention (and its 95% CI). The baseline risk in the control group is calculated using GRADEpro GDT, by dividing the total control group sample size by the total incidence in the control group. This is different from the methods used for NNT calculations, which is the average control risk in the included studies for each outcome. b Downgraded by one level due to limitations in study design or execution (risk of bias); one of the included studies..
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