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A steroid in inhalers is added to a key trial looking for drugs that prevent mild cases of Covid-19 in vulnerable people from deteriorating to the point of hospitalization.
The drug, called budesonide, is the fourth drug to appear in the Principle trial. Two antibiotics, called azithromycin and doxycycline, are also being studied.
Donald Trump’s controversial antimalarial drug hydroxychloroquine was originally part of Principle but was suspended in May.
Budesonide has no known side effects associated with short-term use, is easy to make and inexpensive, researchers say, making it an ideal candidate.
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Principle’s main goal is to find treatments that can be taken in the early days of a coronavirus infection and to stop it in its tracks, thus avoiding serious symptoms.
It is managed by the University of Oxford and funded by the UK government through UKRI and the Department of Health and Welfare.
Researchers currently have more than 2,000 volunteers for the study and are actively seeking to participate.
Only people who have symptoms of Covid-19 (fever, cough, or loss of smell) and who are over 50 and have specific health problems, or who are over 65, can participate in the study. .
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The pre-existing health conditions necessary to qualify 50-64 year olds are: a weakened immune system due to serious illness or medication (e.g. chemotherapy), heart disease or high blood pressure, asthma or lung disease, diabetes, liver disease, stroke or neurological problem, BMI of 35 or more.
Each participant receives either one of the drugs or just standard treatment – the control group.
Patients randomly assigned to the budesonide cohort will receive an inhaler and will be required to take two puffs twice daily for 14 days, with each puff providing a dose of 400 micrograms.
Professor Chris Butler, head of the Principle trial, said: ‘Budesonide is a relatively inexpensive, safe and easy to administer drug for respiratory conditions that may have a role to play in the treatment of Covid-19.
“It is only by recruiting volunteers into a randomized controlled trial like Principle that we can assess whether there are obvious advantages or disadvantages associated with potential treatments like budesonide.
“ We need a lot more volunteers to participate in the trial in order to get the answers we really need to keep people with Covid-19 from being released from the hospital.
“Like vaccines and preventive measures, treatments have an important role to play in minimizing the burden of this disease on society.
Experts hope that budesonide may be successful because other similar drugs, known as corticosteroids, reduce the number of ACE2 receptors on the surface of cells in the human airways.
ACE2 receptors are known to be the way the coronavirus infects human cells and reducing the amount of receptors may be a viable way to block viral entry.
Professor Richard Hobbs, Co-Director of Principle, said: “ We are constantly evaluating different treatments that might be suitable to help people with Covid-19 recover at home without needing to go to the hospital.
“We know from hospital-based trials, like Recovery, that intravenous treatment with dexamethasone corticosteroids can reduce mortality in patients already in hospital.
‘If we find budesonide to be an effective way to treat Covid-19 disease and prevent hospitalization, it could be quickly rolled out across the UK after regulatory approval. ”
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