Table 2.

A summary of the randomized clinical trials on the effects of fluvoxamine in patients with COVID-19

Author/year/references	Study name	Country	Number of participants	Dose and duration	Outcome	Efficacy
Lenze et al. (2020) [16]	STOP COVID	USA	Outpatients with COVID-19	Fluvoxamine (50 mg) (n = 80) or placebo (n = 72) was administered in the evening immediately after the baseline assessment. Then, fluvoxamine (100 mg twice daily for two days) or placebo was administered for tolerance, and subsequently increased to a dose of fluvoxamine (100 mg thrice daily) until day 15	Clinical deterioration (1: shortness of breath or hospitalization for shortness of breath or pneumonia and 2: oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater) of fluvoxamine group (0/80) was significantly lower than that of placebo group (6/72)	Benefit
Lenze et al. (2021) [64]	STOP COVID 2	USA and Canada	Outpatients with COVID-19	Fluvoxamine (50 mg) (n = 272) or placebo (n = 275) was administered on day 1. Then, fluvoxamine (100 mg twice daily) or placebo was administered as tolerated until day 15	This study was terminated early for futility	No benefit
Reis et al. (2022) [66]	TOGETHER	Brazil	High-risk symptomatic unvaccinated patients with COVID-19	Fluvoxamine (100 mg twice daily) (n = 741) and placebo (n = 756) for 10 days	Fluvoxamine group showed significantly lower proportion of emergency setting for more than 6 h or transferred to tertiary hospital due to COVID-19 compared with placebo group	Benefit
Seo et al. (2022) [70]		Korea	Patients with mild or moderate COVID-19 who were admitted to the community treatment centers	Fluvoxamine (50 mg) (n = 26) or placebo (n = 26) was administered on day 1. Then, fluvoxamine (100 mg twice daily for about 10 days) or placebo was administered for tolerance until discharge from the community treatment centers	A single-blind trial showed that there was no significant differences in clinical deterioration between the fluvoxamine group and placebo group	No benefit
Bramante et al. (2022) [71]	COVID-OUT	USA	Patients with COVID-19	Fluvoxamine (50 mg twice daily) (n = 334) and placebo (n = 327) for 14 days	Fluvoxamine did not prevent the primary events such as hypoxemia, an emergency department visit, hospitalization, or death associated with COVID-19	No benefit
McCarthy et al. (2023) [72]	ACTIV-6	USA	Outpatients with mild to moderate COVID-19	Fluvoxamine (50 mg twice daily) (n = 674) and placebo (n = 614) for 10 days	The median time to sustained recovery was 12 days in the fluvoxamine group and 13 days in the placebo group. There was no significant difference between the two groups	No benefit