Efficacy and safety of fluvoxamine in COVID-19 patients admitted to Intensive Care Units (ICU)

Key Messages

In this prospective trial, 51 severe COVID-19 patients hospitalized in intensive care units (ICUs) were treated with fluvoxamine in addition to standard therapy, and compared to 51 patients who received standard therapy alone.
Fluvoxamine dose was 100 mg 3 times a day for 15 days, followed by 50 mg twice a day for an additional 7 days.

Survival rate in fluvoxamine-treated patients was almost twice as high as in the  control group receiving only standard therapy (41.2% vs. 23.5%).

Interestingly, the survival rate of women receiving fluvoxamine was almost 3 times higher than the women who didn’t receive fluvoxamine (58.8% vs 17.6%). 

Fluvoxamine was well tolerated with no significant differences in prevalence of drug-induced complications between the groups.

British Journal of Clinical Pharmacology

Publication Date: November 1, 2021
Peer Reviewed: Yes
Publication Type: Original | Clinical Prospective
DOI: https://www.doi.org/10.1111/bcp.15126

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, Robert Likic


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.

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 mg 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.

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 = .027).

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.