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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 Aug 16, 2021

Yu LM, Bafadhel M, Dorward J, et al. - 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 decreasing hospital admissions or deaths (albeit the results did not reach the superiority threshold).

  • Budesonide (n = 1,073), usual care alone (n = 1,988), or other treatments (n = 1,639) were given to 4,700 patients at random.

  • There are 2,530 SARS-CoV-2-positive patients in the primary analysis model, with 787 getting budesonide, 1,069 receiving usual care, and 974 receiving other treatments.

  • There was an estimated 2·94 days advantage in time to first self-reported recovery in the budesonide group vs the usual care group, with a probability of superiority greater than 0·999, meeting the prespecified superiority threshold of 0·99.

  • For the hospital admission or death outcome, the estimated rate in the budesonide group was 6·8%% vs 8·8% in the usual care group, with a probability of superiority of 0·963, which was lower than the prespecified superiority threshold of 0·975.

  • Two people in the budesonide group and four in the usual care group experienced serious adverse events (hospital admissions unrelated to COVID-19).

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