Safety and efficacy of fluvoxamine in COVID‐19 ICU patients: An open label, prospective cohort trial with matched controls
Martina Calusic, Robert Marcec, Lea Luksa, Ivan Jurkovic, Natasa Kovac, Slobodan Mihaljevic, MD Robert Likic
British Journal of Clinical Pharmacology, doi:10.1111/bcp.15126
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
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'abstract': '<jats:sec><jats:title>Aims</jats:title><jats:p>Fluvoxamine, a selective serotonin reuptake '
'inhibitor (SSRI) and sigma‐1 receptor agonist, has so far shown promise in the prevention of '
'COVID‐19 progression as an early treatment option in three trials. The aim of this study was '
'to evaluate the safety and efficacy of fluvoxamine in COVID‐19 patients if administered later '
'in the course of the '
'disease.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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 100\u2009mg three times daily '
'for 15\u2009days 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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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% (<jats:italic>n</jats:italic>\xa0=\u2009'
'30/51), than in the control group, 76.5% (<jats:italic>n</jats:italic>\xa0=\u200939/51), HR '
'0.58, 95% CI (0.36–0.94, <jats:italic>P</jats:italic>\xa0=\u2009'
'.027).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>',
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