Budesonide, a drug used to treat asthma, has been found to shorten recovery time in COVID-19 patients who are treated at home
In the Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE), 961 patients were randomly assigned to receive inhaled budesonide, a corticosteroid commonly used in inhalers to treat asthma and chronic obstructive pulmonary disease.
Participants were compared with 1819 patients randomly assigned to the usual standard of NHS care alone. 751 of those in the budesonide group and 1028 in the usual care group were SARS-CoV-2 positive.
All patients were aged over 50 with an underlying health condition that put them at more risk of serious COVID-19 illness or aged over 65.
Patients treated with inhaled budesonide were asked to inhale 800 micrograms twice a day for 14 days and were followed up for 28 days.
The results
The results showed the estimated median time to self-reported recovery for inhaled budesonide was 3.01 days shorter compared to usual care (95% Bayesian credible interval 1.13 to 5.42 days), with a high probability (0.999) of being superior to the usual standard of care.
32% of those taking inhaled budesonide recovered within the first 14 days and they have subsequently remained well until 28 days (relative risk 1.46, 95% CI 1.23 – 1.74). They also reported greater wellbeing after two weeks (mean difference in WHO-5 Wellbeing score + 3.37, 95% CI 0.97 – 5.76, p = 0.006).
Among patients who had completed all 28 days of study follow up by 25 March 2021:
- 8.5% (59/692) in the budesonide group were hospitalised with COVID-19
- 10.3% (100/968) in the usual care group (estimated percentage benefit, 2.1% [95% BCI -0.7% – 4.8%], probability of superiority 0.928).
Joint Chief Investigator, Professor Richard Hobbs, Head of Oxford University’s Nuffield Department of Primary Care Health Sciences, 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.”
Professor Fiona Watt, Executive Chair of the Medical Research Council, which co-funded the study, said:
“Researchers involved in the PRINCIPLE trial have overcome considerable logistical hurdles to set up a world-leading rigorous drug trial in people’s homes. We are now rewarded with the first inexpensive and widely available drug that can shorten recovery times for COVID-19 patients in the community. People around the world will be helped to recover faster thanks to these exciting new results.”
Joint Chief Investigator, Professor Chris Butler, a South Wales GP and Professor of Primary Care from the University of Oxford’s Nuffield Department of Primary Care Health Sciences, said:
“PRINCIPLE, the world’s largest platform trial of community-based treatments for COVID-19, has found evidence that a relatively cheap, widely available drug with very few side effects helps people at higher risk of worse outcomes from COVID-19 recover quicker, stay better once they feel recovered, and improves their wellbeing.
“We, therefore, anticipate that medical practitioners around the world caring for people with COVID-19 in the community may wish to consider this evidence when making treatment decisions, as it should help people with COVID-19 recover quicker.
“This exciting finding about the beneficial effects of inhaled budesonide would not have been possible without the contribution of those patients who volunteered to participate. Your gift of taking part will help doctors and nurses provide better evidence-based care for people with COVID-19 worldwide.
“It also stands as a monument to the far-sighted funders of PRINCIPLE, the UK-wide clinical research networks who have been absolutely key to the successful implementation of the trial, all the general practices and clinicians who support PRINCIPLE, NHS Digital, HDRUK, the Therapeutics Task Force and the hard work and dedication of our study team and oversight committees in the Primary Care Clinical Trials Unit.”
The trial is funded by UK Research and Innovation and the National Institute for Health Research (NIHR).
