Study Detail

STOP-COVID19

STOP-COVID19

Status: Closed

Type: Interventional

Funder: Insmed Inc

Sponsor: University of Dundee

CI: Prof James Chalmers

IRAS-Number: 281986

CPMS-ID: 45682

Approval Date: 21 April 2020

Summary:

The aim of this study is to look at how effective Brensocatib is in adult patients in hospital with COVID-19. Brensocatib (INS1007) blocks neutrophil proteases (enzymes which cause tissue damage at the site of inflammation when they are released outside the cell). Because of this it may reduce sudden severe lung injury including acute respiratory distress syndrome (ARDS) (a life-threatening condition where the lungs cannot provide the body's vital organs with enough oxygen). This could result in improvements in the health outcomes, fewer days dependent on oxygen or mechanical ventilation, and a shorter length of hospital stay in patients with COVID-19. Participants will receive one tablet of Brensocatib (25mg) or placebo (a tablet with no active ingredient) once daily for 28 days. Whether participants get the Brensocatib tablet or placebo will be decided randomly. They will have a blood test to check how well their kidneys and liver are working and to check their blood count (haemoglobin level). Blood pressure, pulse, temperature and oxygen levels will also be checked regularly. When they leave hospital they will have a diary to fill in to write down if they have had any new symptoms or felt unwell and if they have had any changes to their normal prescribed medicines. [Study relying on COPI notice]

Description:

This clinical trial is designed to evaluate the potential of Brensocatib (INS1007) as a novel host directed therapy for the treatment of adult patients hospitalized with COVID-19. We hypothesise that Brensocatib, by blocking damaging neutrophil proteases, will reduce the incidence of acute lung injury and acute respiratory distress syndrome (ARDS) in patients with COVID-19, thereby resulting in improved clinical outcomes at day 15 and day 29, fewer days dependent on oxygen or mechanical ventilation, and shorter length of hospital stay. We recently conducted a large phase 2 study (ClinicalTrials.gov Identifier: NCT03218917) of Brensocatib in patients with bronchiectasis designed to test if treatment with Brensocatib could reduce infective exacerbations and reduce neutrophil elastase activity in the lung in bronchiectasis patients. The study met its primary endpoint of time to first exacerbation and key secondary endpoint of the frequency of exacerbations as well as showing marked reductions in neutrophil elastase concentrations in sputum. Neutrophil elastase is a key mediator of ARDS and blockade of elastase in experimental models markedly reduces the severity of acute lung injury and ARDS. Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for 28 days.

Study URL:

https://stop-covid19.org.uk/

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