Published: 27 November 2020
The NIHR-supported PRINCIPLE trial is to start investigating the inhaled corticosteroid budesonide to find out if it can help treat COVID-19 in patients who aren’t in hospital.
Led by the University of Oxford, the PRINCIPLE is the UK’s national platform trial for COVID-19 treatments that can be taken at home. It is evaluating treatments that can help people aged over 50 recover quickly from COVID-19 illness and prevent the need for hospital admission. The study, funded by NIHR and UK Research and Innovation (UKRI) has so far recruited more than 2100 volunteers from across the UK with support from NIHR’s Clinical Research Network.
Inhaled budesonide is often used to treat asthma and chronic obstructive pulmonary disease, with no serious side-effects associated with short-term use.
In some patients with COVID-19, the body’s immune response to the virus can cause high levels of inflammation that can damage cells in the airways and lungs. Inhaling budesonide into the airways targets anti-inflammatory treatment where it is needed most, and can potentially minimise any lung damage that might otherwise be caused by the virus.
Patients taking part in the study will be randomly assigned to receive an inhaler in the post, alongside the usual care from their clinician. They will be asked to inhale two puffs twice a day for 14 days with each puff providing a 400 microgram dose of budesonide. They will be followed up for 28 days and will be compared with participants who have been assigned to receive the usual standard-of-care only.
Professor Chris Butler, from the Nuffield Department of Primary Care Health Sciences, Lead of the PRINCIPLE trial, said “Budesonide is relatively inexpensive, safe and easy-to-administer drug for respiratory conditions that may have a role to play in treating COVID-19. It is only through enrolling volunteers on a randomised controlled trial like PRINCIPLE that we can assess whether there are clear benefits or harms associated with potential treatments like budesonide. We need many more volunteers to join the trial so we can get the answers we really need to keep people with COVID-19 out of hospital. Like vaccines and preventative measures, treatments have an important role to play in minimising the burden of this disease on society.”
Professor Richard Hobbs, from the Nuffield Department of Primary Care Health Sciences, Co-Lead of the PRINCIPLE Trial, said “We know from hospital-based trials, like the RECOVERY trial, that intravenous corticosteroid treatment with dexamethasone can reduce mortality in patients who are already hospitalised. 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.”
The PRINCIPLE trial is open across the UK to people aged over 50 with certain underlying health conditions, or anyone aged over 65. Those with coronavirus symptoms, or a positive test result, can join easily join from home, over the telephone or via their GP practice from anywhere in the UK, without needing face-to-face visits with the trial team in Oxford.