April 13, 2021

Inhaled Budesonide for COVID-19 in People at Higher Risk of Adverse Outcomes in the Community Interim Analyses from the PRINCIPLE Trial

Category: Article Summary

Topic: Testing and Treatment

Keywords (Tags): treatment

• [Pre-print, not peer-reviewed] The inhaled corticosteroid budesonide reduced time to recovery among older ambulatory SARS-CoV-2-infected adults by 3 days, according to an interim analysis of a randomized, open-label trial (PRINCIPLE Trial). In participants either 65 years and older without co-morbidities or less than 50 years with co-morbidities given 14 days of 800 mcg of budesonide twice daily, there were 59 out of 692 (8.5%) COVID-19 related hospitalizations/deaths in the budesonide group vs 100 out of 968 (10.3%) in the usual care group, a result which was not statistically significant (estimated percentage benefit, 2.1% [95% BCI −0.7% – 4.8%], probability of superiority 0.928). The authors note that not all participants had completed 28-day follow-up and that the study will have higher power to detect prevention of hospitalization once all data are analyzed.

Yu et al. (Apr 12, 2021). Inhaled Budesonide for COVID-19 in People at Higher Risk of Adverse Outcomes in the Community Interim Analyses from the PRINCIPLE Trial. Pre-print downloaded Apr 13 from https://doi.org/10.1101/2021.04.10.21254672