LAUSR

BACKGROUND Fluvoxamine, an SSRI and sigma-1 receptor agonist, has so far shown promise in the prevention of COVID-19 progression as an early treatment option in 3 conducted trials. The aim of this study was to evaluate the safety and efficacy of fluvoxamine in COVID-19 patients if administered later in the disease's course. METHODS The study was designed as an open label, prospective cohort trial with matched controls. In April and May 2021, 51 ICU COVID-19 patients hospitalised in the University Hospital Dubrava and University Hospital Centre Zagreb, Croatia, were treated with fluvoxamine 100mg three times daily for 15 days in addition to standard therapy and they were prospectively matched for age, gender, vaccination against COVID-19, disease severity and comorbidities with 51 ICU controls. RESULTS No statistically significant differences between groups were observed regarding the number of days on ventilator support, duration of ICU or total hospital stay. However, overall mortality was lower in the fluvoxamine group, 58.8% (n=30/51), than in the control group, 76.5% (n=39/51), HR 0.58, 95%CI (0.36 - 0.94, p = 0.027). CONCLUSION Fluvoxamine treatment in addition to the standard therapy in hospitalised ICU COVID-19 patients could have a positive impact on patient survival. Further studies on the effects of fluvoxamine in COVID-19 patients are urgently required.