Individually both fluvoxamine and inhaled budesonide help in Covid-19 but the benefits of combination therapy are uncertain.
Treatment with fluvoxamine in high-risk Covid-19 patients reduces the need for hospitalisation. This action likely arises because of an anti-inflammatory and anti-viral effect of the drug. In addition, inhaled budesonide improves the time to recovery and possibly hospital admissions or death. As both drugs appear to be effective, whether the two drugs together might offer additional benefit is unclear.
In the current trial, researchers randomised high-risk, ambulatory patients 1:1 to oral fluvoxamine plus inhaled budesonide or matching placebos. Fluvoxamine 100 mg twice daily and budesonide 800 mcg twice daily were given for 10 days.
The primary outcome was a composite of emergency setting retention for Covid-19 for more than six hours, hospitalisation, and or suspected complications due to progression of the virus within 28 days of randomisation.
Fluvoxamine and inhaled budesonide
The study had 1,476 participants with 738 given fluvoxamine and inhaled budesonide. Symptoms were present for a median of three days before randomisation. The median age was 51 years with women accounting for 60.8% of the total. Overall, 42% of participants had received three doses of a Covid-19 vaccine.
The proportion of patients in an emergency setting for more than six hours or hospitalised due to Covid-19 was lower in the treatment group than the placebo group (relative risk, RR = 0.50, 95% CI 0.25 - 0.92). These results gave a number needed to treat of 53.
The findings suggest that oral fluvoxamine plus inhaled budesonide in high-risk outpatients with early Covid-19 reduces the incidence of severe disease requiring advanced care.
Citation
Reis G et al. Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial. Ann Intern Med 2023.