COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2). It can cause a cough and fever and, in some people, more severe lung disease.   There is currently no vaccine to prevent COVID-19 and no medicines to treat COVID-19. Therefore, there is a need to conduct trials to identify effective treatments for COVID-19.

Each participant will get one Brensocatib tablet or one dummy tablet (placebo) every day for 28 days.

Whether you get the Brensocatib tablet or the dummy tablet will be decided randomly (like tossing a coin, but using a computer). Neither you nor your trial team will be able to decide if you get  Brensocatib or the dummy tablet. To take part in the trial you will need to be happy to either take the Brensocatib tablets or the dummy tablets 

The study is being led by Professor James Chalmers, a Consultant Respiratory Physician at the School of Medicine, University of Dundee.

The trial is being supported by Tayside Clinical Trials Unit, who are providing trial management and data management.

Patients who are eligible to join the trial are over 16 years old with a positive COVID-19 test result. Patients will be invited to join when they present with symptoms of COVID-19 in hospital settings, such as A&E departments or COVID-19 treatment units.

If your doctor thinks you are a suitable candidate, you will be given a patient information sheet and invited to join the trial.

If you are interested in taking part in the trial, you should read the patient information sheet provided by your medical team and you can ask them any questions about the trial. It is entirely your choice if you want to take part, and if you decide not to take part this will not impact on your medical care.

If you do decide to take part, you will be asked to provide informed consent. Following consent, you will be randomly allocated to either receive the trial drug or the placebo. Neither you nor your medical team will know what treatment you have been randomised to.

You will be asked to take 1 tablet per day for 28 days. Both you and your medical team will not know if your tablets are the drug or the placebo. Throughout your treatment, we will collect details about your medical condition. If you leave the hospital before your treatment ends you will be given the trial tablets to take home and the trial team will phone you a maximum of 5 times to ask how you are getting on.

Trial participants are free to withdraw and stop taking the trial medication at any point and this will not impact on your medical care. If you decide you do not want any more information to be collected about you, you are free to stop this, although the de-identifiable information collected up until that point will be analysed.

We do not know if this drug will improve COVID-19 symptoms, but we are investigating whether it can. Taking part in the trial may benefit you or it may benefit future COVID-19 patients.

Brensocatib is an unlicensed medicine, but it has already been used in clinical trials with over 250 people involved. In trials in healthy people and those with lung conditions, the medicine was generally well tolerated.

The most common side effects reported were cough, increased phlegm, headache and breathlessness. However, these are common symptoms for people with lung conditions and were also reported frequently by people taking the placebo tablets.

When you are in hospital you will be closely monitored by the clinical team. We will ask the clinical team to let us know if they have any worries about you taking the trial tablets. We will also check your medical records frequently and report any concerns to the trial doctors and your clinical team. If you leave the hospital before the end of the treatment period, we will phone you to check your health and for any side effects.

The patient information sheet given to you will have contact details for the trial doctor at your hospital.

The trial is being sponsored by the University of Dundee and NHS Tayside.  It is being funded by Insmed  Inc.  The trial is being organised by Professor James Chalmers, University of Dundee.

This trial has been reviewed and approved by Scotland “A” Research Ethics Committee who are responsible for reviewing research which is carried out in humans. The Research Ethics committee does not have any objections to this trial going ahead.

Identifiable information about you and the information collected about you during the trial will be treated confidentially and will be stored securely by your local research team. Only specified members of the research team will have access to this information.

Your anonymised coded trial information will be stored securely on a password-protected database managed by the University of Dundee. Specified members of the data management team will also have access to your identifiable information to manage your information and maintain the database.

The only people who have access to your data are your medical team within the hospital, the trial team analysing the data and the regulatory authorities who oversee the trial conduct.

Your information will be kept securely for 25 years after the end of the trial. After 25 years it will be destroyed.

We will ask the person giving consent to give permission to tell your GP that you are taking part in this trial.

Information which identifies you will not be published or shared.