Early treatment with inhaled budesonide cuts recovery time from COVID-19 by a median of three days in high-risk patients, according to interim findings from the study – whose authors said their findings had the potential to ‘change clinical practice globally’.
Hospitalisations among trial participants were also reduced among those treated with inhaled budesonide – although the researchers said numbers of cases were too low to draw firm conclusions at this stage.
The research – part of the UK’s PRINCIPLE trial – was open to patients with COVID-19 whose symptoms had started within 14 days, and who were aged over 50 with an underlying condition that increased their risk of severe illness or those aged over 65.
Of 1,779 people included in the primary interim analysis, 751 received treatment with 800 micrograms of budesonide twice a day for 14 days and 1,028 received usual care.
Estimated median time to self-reported recovery for the inhaled budesonide group was just over three days shorter than those receiving usual care, ‘with a high probability of being superior to the usual standard of care’, the researchers found.
A total of 32% of patients taking inhaled budesonide recovered within 14 days after joining the trial and remained well until 28 days, compared with 22% in the usual care group – with patients in the budesonide group also reporting greater wellbeing after two weeks.
In patients who had completed 28 days of study follow up by 25 March, 8.5% of those treated with budesonide were hospitalised with COVID-19 compared with 10.3% of those receiving usual care – although the researchers said that ‘since fewer than expected people were admitted to hospital in the trial, and with COVID-19 cases and hospitalisations continuing to drop in the UK, it is not clear from this interim analysis whether budesonide reduces hospitalisations’.
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.’
Professor Butler paid tribute to thousands of patients, GP practices and clinicians who had taken part in primary care-led trials as part of PRINCIPLE.
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 Mona Bafadhel, from Oxford University’s Nuffield Department of Medicine, and a consultant respiratory physician, led the earlier STOIC Phase 2 efficacy study of inhaled budesonide for early COVID-19 and led the development of the budesonide study arm for PRINCIPLE. She said: ‘The news that the findings of the earlier-phase STOIC trial, which reported at the beginning of the year, have been replicated at scale here in the PRINCIPLE trial is outstanding.
‘We are now sure that we have a treatment that will benefit patients with early COVID-19 worldwide Inhaled budesonide is readily available worldwide and commonly used to treat asthma and chronic obstructive pulmonary disease.’
Full data will be published once all remaining patients in the trial have completed follow up, including detailed results on time to recovery and hospitalisations. A total of 92.8% of people randomised to the budesonide group had completed 28 days of follow-up in time for the preliminary findings.