For high-risk outpatients with COVID-19, treatment with oral fluvoxamine plus budesonide reduces the incidence of severe disease needing advanced care, according to a study published online April 18 in the Annals of Internal Medicine.
Gilmar Reis, M.D., Ph.D., from ViRx@Stanford in California, and colleagues conducted a randomized trial to examine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population with confirmed severe acute respiratory syndrome coronavirus 2 infection and a known risk factor for progression to severe disease. Patients were randomly assigned to fluvoxamine plus inhaled budesonide or matching placebos (738 patients in both groups).
The researchers found that compared with the placebo group, the proportion of patients observed in an emergency setting for COVID-19 for more than six hours or hospitalized due to COVID-19 was lower in the treatment group (1.8 versus 3.7 percent; relative risk, 0.50) with a probability of superiority of 98.7 percent. There were no relative effects observed between the groups for any of the secondary outcomes. Compared with the placebo group, there were more adverse events seen in the intervention group, but no important between-group differences were detected.
“Our trial found that the combination of fluvoxamine, 100 mg twice daily, and inhaled budesonide reduced the need for advanced medical care in this high-risk population,” the authors write.
Gilmar Reis et al, Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19, Annals of Internal Medicine (2023). DOI: 10.7326/M22-3305
Annals of Internal Medicine
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