The inhaled corticosteroid medication budesonide, widely used for the treatment of asthma, has been found to aid the recovery of COVID-19 patients when administered at home.
The PRINCIPLE study is a Phase III randomised controlled trial designed to find clear evidence of an effective COVID-19 treatment which can be used in the community to cut recovery time.
Inhaled budesonide was added to the trial on 28 November 2020, with recruitment into this treatment arm halted on 31 March.
An interim report included a total of 961 patients randomly assigned to receive inhaled budesonide at home compared with 1,819 patients randomly assigned to the usual standard of NHS care alone.
Of these participants, 751 participants in the budesonide group and 1,028 in the usual care group were positive for SARS-CoV-2 and included in the primary interim analysis.
Based on the interim analysis, results showed that the estimated median time to self-reported recovery for inhaled budesonide was 3.011 days shorter compared to usual standard of care – indicating a ‘high probability’ of being superior.
In the inhaled budesonide group, 32% recovered within the first 14 days since being randomised into the trial and subsequently remained well until 28 days compared to 22% in the usual standard of care group.
Among patients with 28 days of study follow up, 8.5% in the budesonide group compared with 10.3% in the usual care group were hospitalised with COVID-19.
All patients included in the study were aged over 50 years old and had an underlying health condition that increased their risk of serious COVID-19 illness or were aged over 65 years old.
“For the first time we have high-quality evidence of an effective treatment that can be rolled out across the community for people who are at most risk of developing more severe illness from COVID-19,” said Richard Hobbs, joint chief investigator and head of Oxford University’s Nuffield Department of Primary Care Health Sciences.
“Unlike other proven treatments, budesonide is effective as a treatment at home and during the early stages of the illness. This is a significant milestone for this pandemic and a major achievement for community-based research,” he added.