COVID-19 drugs trial rolled out across UK

A drugs trial into preventing people aged over 50 who are vulnerable to developing serious coronavirus symptoms is now recruiting participants from across the country.

Led by an Oxford University team, the Platform Randomised trial of Interventions against COVID-19 in older peoPLE (PRINCIPLE) trial is testing pre-existing drugs for older patients in the community who show signs of the disease. 

The study - for which the NIHR Clinical Research Network Thames Valley and South Midlands is the lead network - aims to slow or halt the progression of the COVID-19 and prevent the need for hospital admission.

More than 500 GP practices across the country are already recruiting people aged 50 and over with underlying health conditions, or people aged over 65 regardless of underlying health conditions, into the trial. 

From this week the trial is now also screening participants online. This means that regardless of which GP surgery they are registered with, older people with coronavirus symptoms can now pre-screen for the trial at home via an online questionnaire to see whether they can be included. 

PRINCIPLE is trialling a number of low-risk treatments recommended by an expert panel advising the Chief Medical Officer for England. The effectiveness of these treatments will be compared to the current best available care.

In the first phase, the trial is evaluating whether a seven-day course of hydroxychloroquine, a well-known drug used for acute malaria and certain types of arthritis, can reduce the severity of symptoms in vulnerable groups and help avoid hospital admission. The antibiotic azithromycin will soon be added to the trial.

The trial’s Chief Investigator, Professor Chris Butler, said: “With enough people recruited, this trial will give us the vital information we need to understand whether existing drugs can help people recover sooner and at home, without needing to be admitted to hospital – a significant milestone in the course of this pandemic.

“As soon as we find that any one of the drugs in our trial is making a critical difference to people’s health, we want it to be part of clinical practice as soon as it can be introduced.”

Participants will be closely monitored for the first 28 days of the trial, with a health record notes review taking place for up to three months to understand the longer-term effects of the illness on their health. 

Integration of the trial with the Royal College of General Practitioners (RCGP) Research and Surveillance Centre, a rapidly expanding network of over 1,100 GP practices, is enabling this extended follow-up to take place. 

As well as recruiting patients into the PRINCIPLE trial, GP practices in the network continuously monitor and report on the prevalence of infections and diseases in the community through swab testing, including COVID-19.

For details of participating GP surgeries, and a link to the online screening questionnaire, visit https://www.phctrials.ox.ac.uk/hidden-pages/principle-trial/home.