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STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19

NCT04817332 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2023-08-22

Study results available
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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.

Conditions

  • Covid19

Interventions

DRUG

Brensocatib

Selective, competitive, and reversible inhibitor of DPP1

DRUG

Placebo

Matched placebo

Sponsors & Collaborators

  • NHS Tayside

    collaborator OTHER_GOV

  • Insmed Incorporated

    collaborator INDUSTRY

  • University of Dundee

    lead OTHER

Principal Investigators

  • James Chalmers · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2021-02-28
Completion
2021-02-28
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04817332 on ClinicalTrials.gov