Fluvoxamine plus budesonide helps prevent severe COVID-19

High-risk outpatients with early-onset COVID-19 who are treated with oral fluvoxamine plus inhaled budesonide have a reduced incidence of severe disease that warrants advanced care, reveals a study.

This randomized, placebo-controlled, adaptive platform trial involved symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease from 12 clinical sites in Brazil.

From 15 January to 6 July 2022, the investigators randomly assigned patients to receive either fluvoxamine 100 mg twice daily for 10 days plus inhaled budesonide 800 mcg twice daily for 10 days (n=738) or matching placebo (n=738).

Patients in the treatment group were less likely to stay in an emergency setting for COVID-19 for more than 6 hours or be hospitalized due to COVID-19 compared to those in the placebo group (1.8 percent, 95 percent credible interval [CrI], 1.1‒3.0 vs 3.7 percent, 95 percent CrI, 2.5‒5.3; relative risk, 0.50, 95 percent CrI, 0.25‒0.92), with a probability of superiority of 98.7 percent.

For secondary outcomes, including healthcare attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours), time to hospitalization, mortality, patient-reported outcomes, and adverse drug reactions, no between-group difference was observed.

Notably, the intervention group experienced more adverse events than did the placebo group, but no significant between-group differences were seen.

The study was limited by the low event rate, which was consistent with recent trials in vaccinated populations, according to the investigators.