Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial.

ABSTRACT:

Background

Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19.

Objective

To determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population.

Design

Randomized, placebo-controlled, adaptive platform trial. (ClinicalTrials.gov: NCT04727424).

Setting

12 clinical sites in Brazil.

Participants

Symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease.

Intervention

Patients were randomly assigned to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or ma

SUBMITTER: Reis G 

PROVIDER: S-EPMC10111398 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature