Of the composite primary outcome events, 87% were hospitalizations
Findings for the primary outcome were
Similar for the modified intention-to-treat analysis
RR 0.69 (95% BCI, 0.53 to 0.90)
Larger for the per-protocol analysis
RR 0.34 (95% BCI, 0.21 to 0.54)
Deaths in the primary intention-to-treat analysis
OR 0.68 (95% CI, 0.36 to 1.27)
Deaths in the per-protocol population
OR 0.09 (95% CI, 0.01 to 0.47)
There were no significant differences in number of adverse events due to treatment among patients in either group
High-risk outpatients with confirmed COVID-19 had reduced hospitalization needs when treated with fluvoxamine (100 mg twice daily for 10 days)
The mechanism underlying the benefit of this SSRI is unknown but the following hypotheses have been suggested
Fluvoxamine has anti-inflammatory action through activation of the protein S1R that regulates cytokine production
Fluvoxamine has antiplatelet activity
The authors state
We found a clinically important absolute risk reduction of 5.0%, and 32% RR reduction, on the primary outcome of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19, consequent on the administration of fluvoxamine for 10 days
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