SECTION 1: Inhaled budesonide in COVID-19

Budesonide is an inhaled glucocorticoid that may prove to be an effective treatment of early COVID-19 in adults when given for a short duration. 

Clinical trial

• Open-label, phase 2 randomized controlled trial, in UK
• Conducted to assess whether treatment with inhaled glucocorticoids would be an effective treatment for early COVID-19

Intervention

• Steroid (inhaled budesonide) use was compared with usual care in adults within 7 days of the onset of mild COVID-19 symptoms
• Participants were randomly assigned to inhaled budesonide or usual care stratified for
• Age (≤40 years or >40 years)
• Sex (male or female)
• Number of comorbidities (≤1 and ≥2)
• Budesonide dry powder was delivered using a turbohaler at a dose of 400 µg per actuation.

Primary outcome

• COVID-19-related urgent care visit
• Emergency department assessment or hospitalization, analyzed for both the per-protocol and intention-to-treat (ITT) populations

Study findings

• Budesonide was safe, with only five (7%) participants reporting self-limiting adverse events
• For the per-protocol population (n=139), the primary outcome occurred in 10 (14%) of 70 participants in the usual care group and one (1%) of 69 participants in the budesonide group (difference in proportions 0.131, 95% confidence interval [CI] 0.043-0.218; p = 0.004).).
• In the ITT group, the primary outcome occurred in 11 (15%) participants in the usual care group and two (3%) participants in the budesonide group (difference in proportions 0.131, 95%  CI 0.033-0.213; p = 0.009).)

Conclusion

• Budesonide might be an effective treatment for early COVID 19 infection, which can be used in global healthcare systems

Reference: Ramakrishnan S, et al. Lancet Respir Med. April 9, 2021.