First Patients In Yorkshire Recruited Into New Coronavirus Trial

A study examining the effectiveness of low-risk treatments for older people with COVID-19 has recruited its first patients in Yorkshire and Humber.

Funded by UK Research and Innovation (UKRI) and the National Institute of Health Research (NIHR), the Platform Randomised trial of INterventions against COVID-19 in older peoPLE (PRINCIPLE) trial is one of three national priority clinical trials on COVID-19. Led by the University of Oxford, the trial is now set up for over 500 GP practices across the UK, with over 120 sites in Yorkshire and Humber expressing their interest in participating.

While many other clinical trials for COVID-19 focus primarily on providing treatment to those admitted to hospital, the PRINCIPLE trial looks to identify low-risk treatments that can be prescribed by community-based GPs to slow or halt the progression of the disease and prevent the need for hospital admission.

Initially, the trial is evaluating the effectiveness of a drug called hydroxychloroquine, known for its use with conditions such as acute malaria and certain types of arthritis, but not currently used to treat this kind of infection. The trial will also examine the effects of the antibiotic azithromycin.

To be eligible for the trial, participants must be aged over 50 with and underlying health condition, or aged over 65, and have had symptoms of COVID-19 (a continuous new or worsening cough, or a high temperature) for fewer than 15 days. PRINCIPLE aims to recuit over 3,000 people.

Professor Terry McCormack, PRINCIPLE Trial Investigator, Whitby Group Practice said:
“The PRINCIPLE study will not only examine different treatments for coronavirus infection, but also provide us with some idea of how much disease there is in our community settings.

“It has been a tremendous feat of organisation to set up such a huge trial in such a short space of time. Making people aware of the opportunity to take part in this project is one of the major challenges facing us.”

Professor Alistair Hall, Clinical Director of the NIHR Clinical Research Network Yorkshire & Humber, said:

“In the current absence of a vaccine to protect us, it is particularly important that we quickly learn how to prevent and treat Covid-19 both within hospitals and within the community. This investigation is expected to rapidly provide us the answers we need."