Inhaled budesonide for COVID-19 in people at high risk of complications in the community in the UK (PRINCIPLE): A randomised, controlled, open-label, adaptive platform trial
The Lancet Sep 09, 2021
Yu LM, Bafadhel M, Dorward J, et al. - The results indicated that in people with COVID-19 in the community who are at higher risk of complications, inhaled budesonide improves time to recovery, with a chance of also reducing hospital admissions or deaths (although our results did not meet the superiority threshold).
Researchers randomized a total of 4,700 participants to budesonide (n=1,073), usual care alone (n=1,988), or other treatments (n=1,639) between Nov 27, 2020, and March 31, 2021.
Furthermore, 2,530 SARS-CoV-2-positive participants were included in the primary analysis model, with 787 in the budesonide group, 1,069 in the usual care group, and 974 receiving other treatments.
As per the findings, there was an advantage in time to first self-reported recovery of an estimated 2·94 days (95% Bayesian credible interval [BCI] 1·19 to 5·12) in the budesonide group vs the usual care group (11·8 days [95% BCI 10·0 to 14·1] vs 14·7 days [12·3 to 18·0]; hazard ratio 1·21 [95% BCI 1·08 to 1·36]), with a probability of superiority greater than 0·999, meeting the prespecified superiority threshold of 0·99.
The estimated rate was 6·8% (95% BCI 4·1 to 10·2) in the budesonide group vs 8·8% (5·5 to 12·7) in the usual care group (estimated absolute difference 2·0% [95% BCI –0·2 to 4·5]; odds ratio 0·75 [95% BCI 0·55 to 1·03]), with a probability of superiority 0·963, below the prespecified superiority threshold of 0·975, for the hospital admission or death outcome.
There were serious adverse events in two participants in the budesonide group and four in the usual care (hospital admissions unrelated to COVID-19).
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