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

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01744-X/fulltext

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.

“It is important to note, this trial began inhaled budesonide on average 6 days after symptom onset using the same 1,600 mcg/day budesonide protocol as was used in the STOIC trial. The STOIC trial began budesonide on average 3 days after symptom onset. The STOIC trial reported a 91% reduction in urgent care visits including emergency room evaluations and hospital admissions. The  new “PRINCIPLE” trial  reported a three days shortening of illness and 2% absolute and 22.7% relative reduction in hospitalization and death.”

“The just-published (PRINCIPLE) trial selected higher risk patients and will be interpreted by some to suggest that budesonide may be less effective in higher risk patients. I believe it is just as likely to be effective if the dosage and/or frequency of administration are increased appropriately to address the more advanced stage of the illness at 6 days vs 3 days after symptom onset. Likely increase dosages/frequencies would not have been needed in many of the patients, but these MUST be adjusted and tailored for each patient, which did not happen in this study.”

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