STOP-COVID19: Superiority Trial Of Protease inhibition in COVID-19 [COVID-19] [UPH]
Research type
Research Study
Full title
A randomised double-blind placebo-controlled trial of Brensocatib (INS1007) in patients with severe COVID-19
IRAS ID
281986
Contact name
James Chalmers
Contact email
Sponsor organisation
University of Dundee
Eudract number
2020-001643-13
ISRCTN Number
ISRCTN30564012
Duration of Study in the UK
1 years, 0 months, 0 days
Research 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. \nParticipants 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]
REC name
Scotland A: Adults with Incapacity only
REC reference
20/SS/0057
Date of REC Opinion
15 May 2020
REC opinion
Favourable Opinion