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
RCT (n=4700 age ≥50 years, unwell for a minimum of 14 days with COVID but not admitted to hospital) found inhaled budesonide (800 μg twice daily for 14 days) improved time to self-reported cure vs usual care (11.8 vs 14.7 days, HR 1.12, 95% Bayesian credible interval 1.08-1.36).
Source:
The Lancet
SPS commentary:
Authors report that inhaled budesonide reduced the rate of hospital admission or death though the result did not reach statistical significance (6.8% vs 8.8%, OR 0.75, 95% BCI 0.55-1.03).
A related commentary discusses this research. It concludes that on the basis of the trial data, it seems reasonable to consider inhaled corticosteroid use in early COVID-19 in patients similar to the trial population group (people with ongoing symptoms from COVID-19 aged ≥65 years or ≥50 years with specific comorbidities) who are interested in using them. Various subgroup analyses in the study do not provide any pointers to which particular patient or illness characteristics in the included population might be more likely to predict benefit. Because vaccination was uncommon in trial participants, an important question is whether and what effect would be seen in the fully vaccinated population who have a different illness severity and trajectory.
Commentary also notes that recent pragmatic COVID-19 treatment trial platforms provide an important shift in approach to research: trials funded by governments and not industry, answering the crucial questions driven by immediate clinician need and not product marketing, and providing data in the spaces of clinical equipoise—this importance should not be underestimated or lost.