STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
Status:
Completed
Trial end date:
2021-02-28
Target enrollment:
Participant gender:
Summary
COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes
substantial morbidity and mortality. There is currently no vaccine to prevent infection with
SARS-CoV-2 and no therapeutic agent to treat COVID-19. 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. The investigators 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.
High rates of patients requiring mechanical ventilation and overwhelming intensive care unit
capacity has been the major issue contributing to excess deaths in Italy and Spain during the
pandemic and is likely to be a major issue in other countries such as the United Kingdom in
the coming weeks. Treatments that could prevent the requirement for mechanical ventilation or
shorten the duration of ICU stay by reducing the severity of ARDS are therefore the number 1
target for COVID19 therapy.
The investigators recently conducted a large phase 2 study 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.
Participants will be randomised to receive Brensocatib or placebo 25mg orally once daily for
28 days.