Study Detail

STOP-COVID19

STOP-COVID19

Status: Open

Type: Interventional

Funder: Insmed Inc

Sponsor: University of Dundee

CI: Prof James Chalmers

IRAS-Number: 281986

CPMS-ID: 45682

Approval Date: 21 April 2020

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://www.dundee.ac.uk/stories/drug-trial-aims-treat-severe-outcome-covid-19

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