Infections

STOP-COVID19 trial to test novel bronchiectasis treatment


Respiratory researchers in the UK are launching a trial to test a novel treatment for inflammatory lung conditions in hospitalised Covid-19 patients.

Brensocatib, a reversible inhibitor of dipeptidyl peptidase 1 (DPP1) currently being developed by biopharmaceutical company Insmed, will be tested in 300 patients across 10 UK sites after recent positive results in in adult patients with non-cystic fibrosis bronchiectasis.

Study leader Professor James Chalmers, British Lung Foundation Professor of Respiratory Research at the University of Dundee, explained that the mechanism of action of brensocatib they have seen in studies to date “provides a strong rationale” for evaluating the drug in other neutrophil-driven inflammatory conditions.

Speaking with the limbic, Professor Chalmers said the treatment would be trialled in those patients who end up in critical care with a “profound inflammatory response” – the sorts of patients he has been treating as a front-line clinician since February.

“After seeing that so many times you realise what you need is a drug that will stop that inflammatory response before it turns into ARDS.”

Professor Chalmers has been working on trials of bresocatib for the past four or five years. “We have been developing this for use in chronic lung disease and we have a very positive study due to be published shortly showing a dramatic reduction in viral exacerbations,” he said.

Insmed will provide funding and clinical drug supply for the STOP-COVID19 study which is one of several in the UK to be designated as an urgent public health trial.

Like some other UK clinical trials already underway, Professor Chalmers added that it was remarkable how quickly the trial has got to this stage, a testament to a lot of people working very hard behind the scenes. “A trial like this would usually take a year to set up and we have done this in three weeks.”

The drug is being tested in those with severe disease – those who have pneumonia on X-ray or low oxygen levels or other inflammatory markers – essentially those at high risk of ending up on a ventilator.

Researchers are following the WHO suggested scale for clinical improvement but are essentially looking at whether brensocatib can reduce the incidence of acute lung injury and prevent mechanical ventilation. Other outcomes to be monitored include time patients are dependent on oxygen and length of hospital stay.

Professor Chalmers hospital is also taking part in other clinical trials, including the huge RECOVERY study which has already recruited 7,500 patients from 172 sites across the UK looking at usual care compared with one of four treatments; lopinavir-ritonavir, low-dose corticosteroids, hydroxychloroquine, and azithromycin. The investigators have also now gained approval to add in a new randomised arm of tocilizumab in selected patients.

“There is a lot of repurposing going on and it is very likely you will need different treatments for mild cases of disease in primary care to the ones you need for people on a ventilator. The key will be the right drug at the right time in the right patient,” Professor Chalmers said.

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