Inhaled budesonide, a common corticosteroid used in asthma, has been found to shorten recovery times in COVID-19 patients aged over 50 who are treated at home, reports the PRINCIPLE trial of 1,779 participants.
A CAS alert has been issued, stating that inhaled budesonide is not currently being recommended as standard of care but can be considered (off-label) on a case-by-case basis for symptomatic COVID-19 positive patients aged 65 and over, or aged 50 or over with co-morbidities..
Researchers conclude that early treatment with inhaled budesonide at a dose of 800 micrograms twice a day for 14 days will shorten recovery time by a median of three days in patients with COVID-19 who are aged over 50 with an underlying health condition that put them at more risk of complications, or who are aged over 65.
Inhaled budesonide use in COVID was studied for four months from November 2020. The results showed the estimated median time to self-reported recovery for inhaled budesonide was 3.011 days shorter compared to usual care. Participants in the budesonide group also reported greater wellbeing after two weeks.
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.
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. Unlike other proven treatments, budesonide is effective as a treatment at home and during the early stages of the illness.”
PRINCIPLE launched in April 2020 with the intention that drugs shown by the trial to have a clinical benefit could be rapidly introduced into routine NHS primary care. The trial is evaluating a range of potential community treatments for COVID-19 to reduce recovery time and prevent hospital admissions and deaths.
It is recruiting participants who are most at risk of serious COVID-19 illness, either due to their age, symptoms, or an underlying health condition. 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.
Practices can sign up to take part in PRINCIPLE via the RCGP’s Research and Surveillance Centre.