At 12 clinical sites in Brazil, ambulatory patients with early COVID-19 at high risk of progression to severe disease requiring advanced care responded positively to oral fluvoxamine plus inhaled budesonide, according to findings of a randomized, placebo-controlled, adaptive platform trial.
Study participants were 1,476 symptomatic adults with confirmed SARS-CoV-2 infection during the first half of 2022 and a known risk factor for progression to severe disease. Random assignment to 10 days’ treatment with fluvoxamine 100 mg plus inhaled budesonide 800 mcg twice daily or matching placebos produced these changes in a primary outcome of a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalization, and/or suspected complications due to clinical progression of COVID-19 within 28 days of randomization: “The proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to COVID-19 was lower in the treatment group than the placebo group (1.8% [95% credible interval {CrI}, 1.1% to 3.0%] vs. 3.7% [95% CrI, 2.5% to 5.3%]; relative risk, 0.50 [95% CrI, 0.25 to 0.92]), with a probability of superiority of 98.7%. No relative effects were found between groups for any of the secondary outcomes. More adverse events occurred in the intervention group than the placebo group, but no important differences between the groups were detected.”