About 8 out of 10 people who get COVID-19 get better without coming to hospital. Of the patients who do need to be admitted to hospital, most get better but some need to be given oxygen and some need help to breathe (put on a ventilator) before they get better. However, a small number of people do not get better.
A company in the USA, Insmed Inc., have developed a drug called Brensocatib which we think might help people with COVID-19. STOP-COVID19 is a phase III placebo-controlled clinical trial to evaluate if Brensocatib can improve clinical outcomes in COVID-19.
Drug overview: Brensocatib is a new drug and it is not licenced for doctors to prescribe yet. However, trials have already been performed with Brensocatib to test the safety of the drug in healthy people, and to test the effectiveness of the drug in patients with a lung condition called bronchiectasis, to see if it helps control their symptoms. In this trial, Brensocatib reduced inflammation in the lungs in people with bronchiectasis.
We think that Brensocatib may help people with COVID-19 in a similar way to people with bronchiectasis. We want to know if taking Brensocatib means that you need to spend less time in hospital. We also want to find out if you are less likely to need oxygen for a long period or put on a ventilator and if you are more likely to recover from COVID-19.
Patient population: Patients will be invited to join the trial if they have been hospitalised and have a positive test result for COVID-19. This trial aims to recruit 300 patients with COVID-19 from 10 hospitals around the UK.
Trial treatment: All participants taking part in the trial will receive the usual standard of care. Participants will be randomised (by chance) to receive either the trial drug (Brensocatib) or a placebo. Each participant will take either one Brensocatib tablet or one placebo tablet every day for 28 days.
Trial aims: The aim of the trial is to investigate whether patients taking Brensocatib require shorter hospitalisation stays, require less oxygen and ventilation and whether they recover faster from COVID-19 compared to patients who do not take Brensocatib.
Participants will be monitored throughout the 28-day trial treatment. Clinical assessments will be carried out as part of routine care.