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), in people with COVID-19 in the community who are at higher risk of complications.

The trial began enrolment on April 2, 2020, with randomisation to budesonide from Nov 27, 2020, until March 31, 2021, when the prespecified time to recovery superiority criterion was met.

4,700 participants were randomly assigned to budesonide (n=1073), usual care alone (n=1988), or other treatments (n=1639).

The primary analysis model includes 2,530 SARS-CoV-2-positive participants, with 787 in the budesonide group, 1,069 in the usual care group, and 974 receiving other treatments.

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

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