According to results from a study published recently in The Lancet Global Health, there is evidence that indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, researchers assessed the efficacy of fluvoxamine versus placebo in preventing hospitalization, defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19.
The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18–102 years); 58% were female.
The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a tertiary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52–0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%).
Of the composite primary outcome events, 87% were hospitalizations. Findings for the primary outcome were similar for the modified intention-to-treat analysis) and larger in the per-protocol analysis. There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis.
There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01–0·47). They found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups.