Corticosteroid Budesonide 'Shortens COVID-19 Recovery Time'
April 12, 2021 (Medscape.com) – Treatment with the inhaled corticosteroid budesonide was found to shorten recovery time from COVID-19 in those at risk of adverse outcomes by a median of 3 days, preliminary trial results showed.
The results come from the Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE) trial by the University of Oxford.
Among patients who completed all 28 days of treatment by March 25, 8.5% of those who had budesonide were hospitalised, compared with 10.3% who received usual care. After confounding factors were taken into account, this represented an estimated percentage benefit of 2.1%, according to the preprint.
Chris Butler, professor of primary care at the university’s Nuffield Department of Primary Care Health Sciences, told a briefing hosted by the Science Media Centre: “That that could make a considerable difference to the impact upon secondary care, but of course most importantly on the patients themselves.”
An NHS alert said inhaled budesonide is not yet recommended as standard care “but can be considered (off-label) on a case-by-case basis for symptomatic COVID-19 positive patients aged 65 and over, or aged 50 or over with comorbidities.”
Trial Involved Patients With Underlying Conditions
People were eligible for recruitment if they had developed symptoms of COVID within the previous 14 days and were either aged 65 and older or were over 50 with a comorbidity that put them in a higher risk category.
Trial participants received usual care plus 800μg of inhaled budesonide (Pulmicort Turbohaler, AstraZeneca) twice daily for 14 days, or usual care alone.
All participants were treated at home or in other community settings.
The results suggested that the estimated median time to self-reported recovery from COVID-19 was 3.011 days shorter among the 961 patients who took budesonide compared with the 1819 people who were randomly assigned to receive usual care alone.
Researchers said 32% of those taking budesonide recovered within the first 14 days of treatment, compared with 22% in the usual care group.
Participants in the budesonide group also reported greater wellbeing after 2 weeks, they added.
Recruitment for the trial stopped on March 31 after it was decided that enough patients had been enrolled to establish whether or not the drug had any meaningful benefit on time to recovery. Also, declining hospital admissions meant that further data on whether the drug could reduce admissions and deaths was unlikely to be obtained.
Prof Richard Hobbs, trial joint chief investigator, said: “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.
“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.”
Gail Hayward, an associate professor from the University of Oxford, and a co-investigator on the trial, said: “Working out how much the treatment costs is a bit complicated because it also involves the overall picture of trying to prescribe it, etc, but just the cost of the inhaler itself we think is about £14, so compared to many, many treatments that are being used for COVID this is really cheap.”
Detailed results on recovery time and hospitalisations will be published after all the remaining patients enrolled in the trial have completed their follow-up and the results analysed, the researchers said.
In the meantime, PRINCIPLE will continue to investigate the effects of treatment in the community with the anti- inflammatory colchicine and the antiviral favipiravir.
‘Exciting and Important’
Kevin McConway, emeritus professor of applied statistics at The Open University, described the preprint results as “appropriate”. He said there was “some evidence that budesonide reduces the risk of being hospitalised, but this hasn’t yet reached the level where the researchers can be sufficiently confident that there’s a real difference in hospitalisation risk”.
Dr Penny Ward, visiting professor in pharmaceutical medicine at King’s College London described the size of the effect as “modest”. She said: “The study was intended to investigate treatment effect in persons expected to be at higher risk of severe COVID and hospitalisation, but the subject group included, and the low rate of hospitalisations observed, suggest that it mainly recruited subjects with mild disease, limiting the applicability of the findings to other subjects with more severe comorbidities or at higher immediate risk of severe disease.”
Professor Simon de Lusignan, medical director for the Royal College of GP’s Research and Surveillance Centre, said: “These latest results from the PRINCIPLE trial are both exciting and important.”
He added: “Having easily accessible medication that can help patients recover faster from COVID-19 will enhance the care we are able to deliver, close to home, where patients want it most.”