Does the combination of fluvoxamine and inhaled budesonide increase treatment effects in a highly vaccinated population with early COVID-19?
Study design
Randomized, placebo-controlled, adaptive platform trial.
Population
- Number of patients studied: 1476
- Inclusion criteria: Symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease.
- Exclusion criteria: Not specified
Interventions
- Experimental group: Fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days)
- Control group: Matching placebos
Primary outcome: 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.
Secondary outcomes
- Health care attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours): no relative effects were found between groups
- Time to hospitalization: no notable difference in time to recovery was detected between groups (hazard ratio, 1.02 [95% CrI, 0.91 to 1.13])Treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care.
Safety outcomes or Adverse Events
| Outcome | Treatment Group | Placebo Group |
|---|---|---|
| Emergency setting retention for COVID-19 >6 hours | 1.8% (95% CrI, 1.1% to 3.0%) | 3.7% (95% CrI, 2.5% to 5.3%) |
| Hospitalization due to COVID-19 | 1.8% (95% CrI, 1.1% to 3.0%) | 3.7% (95% CrI, 2.5% to 5.3%) |
| Mortality | Same in both groups | Same in both groups |
| Health care attendance (hospitalization or ER visit >6 hours) | Same in both groups | Same in both groups |
| Time to hospitalization | Same in both groups | Same in both groups |
| Patient-reported outcomes | Same in both groups | Same in both groups |
| Adverse drug reactions | More in treatment group | More in placebo group |
| Serious adverse events | 16% | 14% |
Conclusion
Treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care.