A trial known as PRINCIPLE has begun investigating the inhaled corticosteroid budesonide as a treatment for COVID-19 in the UK.
The Platform Randomised trial of Interventions against COVID-19 in older peoPLE (PRINCIPLE) has recruited more than 2,100 individuals in the UK to test several therapies, with the goal of finding treatments for patients over the age of 50 years that could help speed recovery and possibly prevent hospital admissions in an already overburdened system.
Budesonide was picked because it was known to be generally very well tolerated from its widespread use in the treatment of asthma and COPD, with no serious side-effects associated with short-term use.
In other studies this year, the systemic corticosteroid dexamethasone was effective in some patients hospitalised with COVID-19. Researchers postulated that an inhaled corticosteroid could be easily and cheaply administered at home, and if effective might prevent hospital admissions.
The SARS-CoV-2 virus binds to ACE2 receptors that line cells in the airways, and laboratory studies have shown that inhaled corticosteroids can reduce the number of those receptors. This may block entry of the virus into cells.
The inhaled corticosteroid’s anti-inflammatory effects may also slow or minimise damage to the lungs by delivering the agent where it is needed most.
“We know from hospital-based trials, like RECOVERY, that intravenous corticosteroid treatment with dexamethasone can reduce mortality in patients who are already hospitalised,” said Professor Richard Hobbs, of the Nuffield Department of Primary Care Health Sciences and co-lead of the PRINCIPLE trial.
“If we find that budesonide is an effective way of treating COVID-19 illness and preventing hospital admission, then it could be rolled out quickly across the UK following regulatory approval.”
Inhaled budesonide and other inhaled corticosteroids are under investigation in several other trials as well, including the UK-based STOIC trial as well as one in Spain and one in the US.
Associate Professor Mona Bafadhel, a respiratory medicine specialist at the University of Oxford and principal investigator on the STOIC trial, said she helped guide the PRINCIPLE team to add inhaled corticosteroids based on her trial’s earlier experience. The STOIC trial has enrolled 130 volunteers to date, and Associate Professor Bafadhel told the limbic that discussions regarding an early interim analysis are now ongoing.