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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