Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.

The study team screened 9,803 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 teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo, with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6%.

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