CompletedPhase IIIInterventional

STOP-COVID19: Superiority Trial Of Protease inhibition in COVID-19 (coronavirus infection)

The STOP-COVID19 trial is testing an experimental medicine called brensocatib in adults hospitalised with COVID-19. COVID-19 can cause severe lung inflammation and breathing trouble, sometimes leading to pneumonia. Doctors are testing whether blocking certain inflammatory proteins can protect the lungs from damage and help patients recover more quickly. Participants take one tablet by mouth each day for 28 days. Half of the patients receive brensocatib, while the other half receive a matching dummy tablet (placebo) alongside standard hospital care. Neither the patients nor their hospital doctors choose which tablet is given, ensuring the test is fair. The trial monitors patients' oxygen levels, chest scans, and general recovery. The aim is to find out if brensocatib is a safe and effective way to help people who are seriously unwell in hospital with coronavirus.

At a glance

Status

Completed

Phase

Phase III

Enrolment target

400

Start

20 May 2020

Estimated completion

31 Jan 2021

COVID-19 (SARS-CoV-2 infection)

What is this study about?

COVID-19 is a chest infection caused by the coronavirus. While many people have mild symptoms like a cough or fever, some become very unwell and need to go to hospital. In severe cases, the body's immune system overreacts to the virus, creating intense swelling and fluid buildup in the lungs. This can make it difficult for oxygen to enter the blood, leaving patients short of breath and needing extra oxygen support.

The STOP-COVID19 clinical trial aims to see if an experimental medicine called brensocatib (also known as INS1007) can reduce this harmful inflammation. Brensocatib works by blocking specific enzymes in white blood cells that trigger tissue swelling. By cooling down this immune response, doctors hope to protect the delicate air sacs in the lungs and prevent severe complications.

Finding treatments that stop lung damage is a vital step in helping patients recover faster and go home sooner. This research is run through hospitals like Ninewells Hospital in the UK, where doctors closely monitor patients to see if adding this daily tablet to normal hospital treatment leads to better breathing and quicker recovery.

Key takeaways

The trial tests if the tablet brensocatib helps hospitalised patients recover from COVID-19.
Participants take one tablet a day for 28 days alongside standard hospital care.
Half of the patients take the active medicine and half take a dummy tablet (placebo).
Only people aged 16 and over admitted to hospital with COVID-19 can take part.
Participation is entirely voluntary and you can leave the study at any time.

Who may be eligible?

This trial is for adults aged 16 and over who have been admitted to hospital as an inpatient with suspected or confirmed COVID-19. To be included, patients need to have arrived at the hospital within the past 96 hours, or have developed their symptoms within the last 96 hours if they were already in hospital for another health reason.

Participants must also show signs that the virus is affecting their chest or breathing. This might include low blood oxygen levels, a need for oxygen therapy, crackling sounds heard by a doctor through a stethoscope, clear changes on a chest X-ray or CT scan, or low levels of certain white blood cells.

Patients must be able to swallow tablets by mouth. Either the patient or their legal representative must give written consent after understanding what the study involves. People who cannot swallow medication or who are not admitted to hospital cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 16 or over.
I have been admitted to hospital with suspected or confirmed COVID-19.
I was admitted to hospital (or developed symptoms) within the last 96 hours.
I have breathing symptoms, low oxygen levels, or signs of lung infection on a chest scan.
I am able to swallow tablets by mouth.
I (or my family representative) am able to provide informed consent.

Answer every question to see your result.

What does participation involve?

If you take part, you will be placed into one of two groups by chance (randomly). One group receives the active brensocatib tablet (25 mg), and the other group receives an identical dummy tablet (placebo). You take one tablet each day by mouth for 28 days.

Throughout your stay in hospital, the clinical team will carry out regular checks. These include checking your oxygen levels, measuring your temperature and blood pressure, taking routine blood tests, and performing chest X-rays or scans when needed. You will continue to receive all the usual hospital care and medicines you need for COVID-19 alongside the trial tablet.

If you leave hospital before the 28 days are finished, the research team will guide you on how to continue taking the medication at home and how they will check in on your recovery. The total treatment period lasts 4 weeks, with follow-up checks to monitor your progress and health.

Potential risks and benefits

Taking part may or may not help your COVID-19 symptoms directly, but the information collected will help doctors learn how to treat future patients more effectively. Brensocatib has been tested in other trials and was generally well tolerated. Reported side effects include headaches, cough, more phlegm, or breathlessness, although these can also be symptoms of chest infections. Rare side effects include skin thickening on the hands or feet and gum irritation. Your hospital team will monitor you closely for any unwanted effects. Taking part is completely voluntary; you can stop taking the study medicine at any time without your normal NHS care or treatment being affected.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Ninewells Hospital and Medical School
Unverified
Dundee, Scotland
Wishaw Hosptial
Unverified
Wishaw, Scotland
Raigmore Hospital
Unverified
Inverness, Scotland
Aberdeen Royal Infirmary
Unverified
Aberdeen, Scotland
Queen Elizabeth Hospital Birmingham
Unverified
Birmingham, England
Cardiff and Vale University Health Board
Unverified
Cardiff, Wales
Forth Valley Royal Hospital
Unverified
Larbert, Scotland
NHS Fife
Unverified
Kirkcaldy, Scotland
Queen Alexandra Hospital
Unverified
Portsmouth, England
Glenfield Hospital
Unverified
Leicester, England
Royal United Hospital
Unverified
Bath, England
University Hospitals of North Midlands NHS Trust
Unverified
Stoke-on-trent, England

Common questions

What is the medicine being tested?

The medicine is brensocatib (also called INS1007), a tablet that aims to reduce swelling and inflammation in the lungs caused by the immune response to the virus.

What is a placebo?

A placebo is a harmless dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps doctors see if changes in health are truly caused by the study drug.

Will I still get my regular COVID-19 treatments?

Yes. Every participant receives full standard hospital care, including oxygen and other proven treatments, in addition to the study tablet.

Can I volunteer from home?

No. This study only includes patients who are already admitted to a participating hospital due to COVID-19.

What happens if I change my mind during the trial?

You are free to leave the trial at any point. Deciding to withdraw will not change your relationship with your medical team or the quality of your hospital care.

How to find out more

Margaret Band

m.band@dundee.ac.uk +44 (0)1382 383097 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.