COVID-19 Drugs: Queensland University of Technology and Oxford University Exploring Budesonide Inhaler Therapy For Early COVID-19 Patients In New Trial
: Medical researchers from Queensland University of Technology and Oxford University are working in collaboration to begin human clinical trials of inhaled corticosteroids, commonly used for asthma patients, on patients with COVID-19. The researchers believe that this could be useful for patients with the novel coronavirus infection.
Research has shown that some corticosteroids, such as dexamethasone, could reduce the inflammation of the respiratory tract in these patients and benefit them by alleviating the symptoms of severe disease.
In this new trial researchers are studying if the steroid inhalers used for reducing the exacerbations of asthma could be useful for patients with early COVID-19 and reduce their risk of severe disease.
Dr Dan Nicolau, lead researcher on the team and an Associate Professor at Queensland University of Technology or QUT, explained that the asthmatics and those with chronic lung disease and chronic obstructive pulmonary disease (COPD) were on regular inhaler therapy with corticosteroids, were found to have a lesser risk of severe illness in the early phase of the pandemic.
He said that this was paradoxical because those with long term lung disease were initially considered to be at a higher risk of a respiratory viral infection such as SARS-CoV-2.
Dr Nicolau told Thailand Medical News, “This seemed paradoxical because COVID-19 affects the lungs and these patients have lung problems so they should be more at risk of severe disease from the virus.”
Dr Nicolau said, “One explanation for the low numbers was that something these people were doing regularly was protecting them and that, logically, was that they routinely used inhalers for their chronic lung problems. Ideally, it may be that the corticosteroid therapy would be given to anyone with a new, dry cough, and while they are awaiting their COVID test results.”
Based on their speculation, the earlier a corticosteroid inhaler is started for those with symptoms of COVID-19, the lesser their risk of getting severely ill.
This hypothesis or speculation, he said, was based on the mathematical modeling by the research team.
The new clinical trial has been registered under the name of STOIC (STerOids In COVID-19). It has begun recruiting patients at the Churchill Hospital in Oxford, England. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001889-10/GB#E
The clinical trial study is being led by Associate Professor Dr Nicolau, who is also a mathematician, physician, and Australian Research Council Future Fellow.
The researchers have plans to recruit a total of 478 participants in the study. Some of the patients would be administered the corticosteroid (Budesonide) containing inhaler while others would be prescribed a placebo inhaler. Budesonide is widely used for control of symptoms of asthma and prevent its exacerbations.
The clinical trial participants would be those with new-onset symptoms of COVID-19. The researchers wrote that the trial aims to “Evaluate the effect of inhaled corticosteroid (ICS) therapy comp
ared to standard care in participants with early CoVID-19 illness in reducing COVID related emergency department presentations or hospital admissions”. Both male and female patients over the age of 18 years would be included in the trial.
The clinical trial endpoints that would be recorded for each of the participants would be the need for hospitalization within 28 days of inclusion into the trial. Participants would be evaluated and followed up at baseline and then on days 7, 14, and 28.
Should the trial be successful, Budesonide inhaler therapy could be a low cost and readily available therapy for early COVID-19 patients. It would reduce their risk of getting severe respiratory complications.
Dr Nicolau added that it would be September before any conclusive results could be obtained from the trial and the efficacy of the inhalers proven. Before that, it is important to wait for concrete evidence, he warned.
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