Published: 12 April 2021
Treatment with the inhaled asthma drug budesonide reduces recovery time in patients with COVID-19 who are treated at home and in other community settings, new results from research funded and supported by the NIHR have shown.
The treatment, which was used in people aged over 50 who were at higher risk of a poor outcome from the illness, shortened recovery time by around two and a half to three days.
Inhaled budesonide is a safe, relatively inexpensive and readily available corticosteroid drug commonly used around the world in inhalers to treat asthma and chronic obstructive pulmonary disease.
The Platform Randomised Trial of Interventions against COVID-19 in Older People (PRINCIPLE) is the world’s largest Phase 3 platform trial to find clear evidence of an effective COVID-19 treatment for use in the community. The findings have potential to change how COVID-19 is treated in its early stages in non-hospital, community settings both in the UK and internationally.
PRINCIPLE is funded by the NIHR and UK Research and Innovation, and has been designated an Urgent Public Health national priority platform trial. To date, more than 4,700 patients have volunteered to join PRINCIPLE, making it the world’s largest platform trial of COVID-19 treatments to take place in community settings.
For the interim analysis of the budesonide arm of PRINCIPLE, 751 patients randomly assigned to receive inhaled budesonide at home were compared with 1,028 patients who received usual NHS care. 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.
The results showed that people who took inhaled budesonide reported a recovery time 3.011 days shorter than those who received usual care.
A third (32%) of study participants who took inhaled budesonide recovered in 14 days and remained well until 28 days, compared with one in five (22%) of people who received usual care. Participants in the budesonide group also reported greater wellbeing after two weeks.
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.
“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.”
PRINCIPLE launched in April 2020 and is evaluating six different potential community treatments for COVID-19 to reduce recovery time and prevent hospital admissions and deaths.
In January 2021, PRINCIPLE showed that the antibiotics azithromycin and doxycycline are not effective treatments for COVID-19 in the early stages of the illness, changing clinical practice in the UK and internationally. PRINCIPLE continues to investigate the effects of treatment in the community with colchicine, a commonly used anti-inflammatory, and favipiravir, an antiviral used in Japan to treat influenza.
Read more about the budesonide findings on the University of Oxford website