Asthma Drug Shortens Recovery Time in Some COVID-19 Patients

Early treatment with inhaled budesonide shortens recovery time in patients with COVID-19 who are at higher risk of more severe illness and are treated in the community, the latest trial led by Trinity Professorial Fellow Chris Butler has found. 

Inhaled budesonide, a common corticosteroid, is the first widely available, inexpensive drug found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home and in other community settings, reports the UK’s PRINCIPLE trial in 1,779 participants.

PRINCIPLE is Oxford University’s Platform Randomised Trial of Interventions against COVID-19 in Older People trial, led by Professor Butler and the University’s Nuffield Department of Primary Care Health Sciences. It is the world’s largest Phase 3 platform randomised controlled trial to find clear evidence of an effective COVID-19 treatment for use in the community that can significantly shorten recovery time. As one of the UK Government’s national priority platform trials, findings from PRINCIPLE have potential to change how COVID-19 is treated in its early stages in non-hospital, community settings in the UK and internationally.

Inhaled budesonide is a safe, relatively inexpensive and readily available corticosteroid commonly used around the world in inhalers to treat asthma and chronic obstructive pulmonary disease. It was added to the PRINCIPLE trial on 28th November 2020.

Patients with COVID-19 symptoms that started within 14 days and who are at higher risk of a poor outcome from the illness could join the trial and those with a positive SARS-CoV-2 result were included in the main analysis. Patients treated with inhaled budesonide were asked to inhale 800 micrograms twice a day for 14 days and were followed-up for 28 days. 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.

Professor Butler, the trial’s Joint Chief Investigator, 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.’

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.’

As soon as all remaining patients in the trial have completed their follow-up and a full analysis has been completed, detailed results on time to recovery and hospitalisations will be published. For this preliminary report, 92.8% of people randomised to the budesonide arm had the opportunity to complete 28 days of follow-up. 

PRINCIPLE is funded by a grant to the University of Oxford from UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research as part of the UK Government’s rapid research response fund.