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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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