GPs to trial COVID-19 drug

Some people with COVID-19 symptoms will be offered an anti-malarial drug by GPs for a study into helping sufferers recover from the infection.

The PRINCIPLE study will examine whether hydroxychloroquine can reduce the need for the at-risk and over 65s to go to hospital or help speed up their recovery. 

The University of Oxford study is being led across the National Institute for Health Research (NIHR) by the NIHR Clinical Research Network Thames Valley and South Midlands (LCRN).

Family doctors will recruit patients aged over 65 or 50 to 64 years with underlying health conditions who have COVID-19 symptoms.

They will be tested for COVID-19 where possible and receive the usual care plus hydroxychloroquine twice a day for seven days or usual care without hydroxychloroquine. 

The drug has been used for many years for conditions such as malaria and certain types of arthritis but is not currently used for coronavirus because it is not yet known whether it is an effective treatment. 

The antibiotic azithromycin will soon be added to the trial, as an alternative to hydroxychloroquine for some participants. 

PRINCIPLE aims to recruit over 3,000 people and new treatments can be added when these become available.

It has received £1.7m from the NIHR and UK Research and Innovation (UKRI) as part of £14.1m funding for 21 projects. 

Another LCRN-supported project that has received £600,000 funding is What’s the STORY (Serum Testing of Representative Youngsters).

The University of Oxford with Public Health England project will use an existing study of infectious disease immunity in ages 0 to 19 to study the presence of antibodies against COVID-19.

Antibodies are a marker of having had the disease and now having immunity. The project will study about 400 people per month for the duration of the outbreak and collect information on recent respiratory illnesses and relevant medical history.  

PRINCIPLE trial chief investigator Professor Chris Butler said: “This trial will allow us to make treatments that are proven to be effective as widely, and as rapidly available as possible. However, we do not want to give people medication that does not work and may simply put them at unnecessary risk of side effects. 

“At the moment we really do not have enough information about whether any benefits from taking these medicines for COVID-19 outweigh any possible harms. That is why we urgently need to do a proper trial, so we have the information we need to guide the provision of best care for all.” 

Jonathan Sheffield, NIHR COVID-19 Research Operations Director, said: “In just a few weeks the UK's health and science communities have risen to the challenges presented by COVID-19 in deeply inspiring ways. Alongside the selfless work being done by our amazing frontline NHS staff, our world-leading research community is also putting its cutting-edge expertise to use in myriad ways.  

“Though the studies announced today may vary in theme, they all represent some of the best and brightest scientific research into Covid-19 being done anywhere in the world.”

The projects will run over a maximum 18 months and have been coordinated with other funders and the World Health Organization to ensure there is no duplication of effort and expertise is applied strategically.  

Funding announced last month included LCRN-supported studies into possible drug treatments for hospitalised COVID-19 patients and a vaccine trial into the infection.