Combination of fluvoxamine and inhaled budesonide reduces severe COVID-19 in high-risk outpatients COVID19 Fluvoxamine Budesonide RandomizedTrial HighRiskOutpatients DiseaseProgression Prevention SevereCOVID19 AdvancedCare AnnalsofIM
By Neha MathurApr 20 2023Reviewed by Danielle Ellis, B.Sc. In a recent study published in the Annals of Internal Medicine, researchers performed a randomized, placebo-controlled trial among adults with confirmed severe acute respiratory syndrome coronavirus 2 infection with at least one risk factor that facilitated the development of severe disease to assess the effect of treatment with fluvoxamine and inhaled budesonide combined vs. placebo.
All these trials have demonstrated the clinical benefits of these two medications alone but not in combination. Combining interventions with proven benefits might improve the effectiveness of individual drugs. It is significant because there is a critical need for accessible and effective treatment of early SARS-CoV-2 infection. COVID-19 outpatients for whom oral protease inhibitors or monoclonal antibodies are inaccessible need these treatments the most.
The RCT team administered 100 mg twice daily and 800 mcg twice daily dosages of fluvoxamine and inhaled budesonide for 10 days. They recorded the primary outcome for 28 days post-randomization using a Bayesian framework for analysis. It was a combination of COVID-19-related hospitalization, retention in an emergency department for physician observation for ≥six hours, and other complications related to disease severity.
Related StoriesThe study approach helped identify people under observation in an ED setting for ≥six hours with more severe symptoms. In Brazil, retention of COVID-19 patients in specialized ED settings was as important as hospitalization when outpatient numbers peaked during the pandemic waves. Patients in these settings represented those who experienced clinical worsening of COVID-19 but remained nonhospitalized due to hospital capacity issues.
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