Inhaled budesonide shortened COVID-19 recovery time by a median of 3 days in non-hospitalised patients over 50 years who were at higher risk of more severe illness, an interim analysis of data from the UK's PRINCIPLE trial has shown.
Overall, 32% of patients taking inhaled budesonide recovered within the first 14 days of being randomised into the trial and subsequently remained well until 28 days, compared with 22% of those randomised to usual care alone.
Hospitalisation was also less frequent in the budesonide group than in the usual care group (8.5% vs 10.3%) but the researchers said the numbers were too low to conclude at this stage that budesonide reduces hospitalisations.
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.’
An interim position statement issued by the four UK government health departments says inhaled budesonide is not currently being recommended for routine use, but can be prescribed on a case-by-case basis.
PRINCIPLE (Platform Randomised Trial of Interventions against COVID-19 in Older People) enrolled patients with COVID-19 symptoms who were aged at least 65, or at least 50 with an underlying health condition. Patients treated with inhaled budesonide were asked to inhale 800 microgram twice daily for 14 days and were followed up for 28 days.
For the interim report, 961 patients were randomly assigned to receive inhaled budesonide at home and were compared with 1819 patients randomised to the usual standard of NHS care alone. Of these, 751 people in the budesonide group and 1028 in the usual care group tested positive for SARS-CoV-2 and were included in the primary interim analysis.
Interm analysis of data up to 25 March 2021 showed the estimated median time to self-reported recovery was 3 days shorter with inhaled budesonide than with usual standard of care, with a high probability of budesonide treatment being superior to usual care.
Participants in the budesonide group also reported significantly greater wellbeing after two weeks.
Joint chief investigator Professor Chris Butler, a South Wales GP and professor of primary care at the University of Oxford, 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.'
PRINCIPLE began in April 2020 with the aim of evaluating potential treatments for COVID-19 in the community. As a platform trial, it is designed to investigate multiple treatments, with new interventions added as the trial progresses.
In January 2021, PRINCIPLE demonstrated that the antibiotics azithromycin and doxycycline are not effective treatments for COVID-19 in the early stages of the illness. The trial continues to investigate the effects of colchicine and favipiravir, an antiviral used in Japan.