Inhaled corticosteroid budesonide will be investigated as part of the UK national priority platform study for COVID-19 treatments that can be taken at home.
Led by the University of Oxford, the Platform Randomized trial of Interventions against COVID-19 In Older People (PRINCIPLE) is evaluating treatments that can help people over 50 recover faster from COVID-19 disease and avoid hospitalization. The study has so far recruited more than 2,100 volunteers from across the UK.
Inhaled budesonide is often prescribed as part of the long-term treatment of asthma and chronic obstructive pulmonary disease without serious side effects with short-term use.
In some patients with COVID-19, the body builds a significant immune response to fight the virus, causing high levels of inflammation that can damage human cells in the airways and lungs. Breathing budesonide into the airways targets anti-inflammatory treatment where it is needed most, and can potentially minimize any lung damage that would otherwise be caused by the virus.
SARS-CoV-2 (the virus that causes COVID-19) binds to ACE2 receptors (angiotensin converting enzyme 2) that line the cells in the airways, access human cells, and replicate inside. Laboratory studies suggest that inhaled corticosteroids reduce the number of ACE2 receptors in the airways and thus may block the virus’ access to human cells.
Professor Chris Butler, of the Nuffield Department of Primary Care Health Sciences, head of the PRINCIPLE study, said: ‘Budesonide is a relatively inexpensive, safe and easy to administer drug for respiratory diseases that may play a role in the treatment of COVID- 19. Only by enrolling volunteers in a randomized controlled trial such as PRINCIPLE can we assess whether there are clear benefits or drawbacks associated with potential treatments such as budesonide. We need a lot more volunteers to join the study so we can get the answers we really need to keep people with COVID-19 out of the hospital. Like vaccines and preventive measures, treatments play an important role in minimizing the burden of this disease on society. ‘
Patients participating in the study will be randomly assigned to receive an inhaler in the mail and their physician’s usual standard of care. They will be asked to inhale two puffs twice a day for 14 days, each puff yielding a dose of 400 micrograms of budesonide. They are followed up for 28 days and compared with participants assigned to receive usual standard care only.
Professor Richard Hobbs, Nuffield’s Department of Primary Health Sciences, co-leader of the PRINCIPLE trial, said: “We are constantly evaluating different treatments that may be appropriate to help people with COVID-19 recover at home without having to go to the hospital. We know from clinical trials, such as RECOVERY, that intravenous corticosteroid treatment with dexamethasone can reduce mortality in patients already hospitalized. If we find that budesonide is an effective way to treat COVID-19 disease and prevent hospitalization, it could be rolled out quickly in the UK after regulatory approval. “
The PRINCIPLE trial primarily evaluates whether treatment prescribed in the first 14 days of COVID-19 disease can speed recovery and avoid the need for hospitalization. It is open across the UK to people over 50 with certain underlying health conditions, or anyone over 65. People with coronavirus symptoms or a positive test result can easily participate from home, over the phone or through their GP practice from anywhere in the UK, without having to make personal contact with the Oxford testing team.
The other treatments currently being evaluated in the PRINCIPLE trial are doxycycline and azithromycin, both commonly prescribed antibiotics believed to have additional anti-inflammatory properties.
The PRINCIPLE study is being conducted by the Primary Care Clinical Trials Unit of the Department of Primary Care Health Sciences at Oxford University in Nuffield. It is funded by a grant to the University of Oxford from the UK’s Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research as part of the UK Government’s Rapid Research Response Fund.
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