Kent, Surrey and Sussex residents urged to take part in community coronavirus trial
Following a rise in the number of COVID-19 cases, people in Kent, Surrey and Sussex with early symptoms are urged to take part in a clinical trial to improve care and reduce hospital admissions.
The PRINCIPLE trial is recruiting people with early COVID-19 symptoms who are aged 50 and over with underlying health conditions and otherwise healthy people aged 65 years and over.
The NIHR-funded study, which is led by an Oxford University team, is evaluating whether certain commonly used medicines may prevent patients in the community with COVID-19 from becoming more unwell and needing hospital care.
Local NHS researchers and GPs involved in the trial are urging people experiencing symptoms likely to be caused by a COVID-19 infection, for no more than 14 days, to take part. People may also be eligible to join the study if they have had a positive test for COVID-19 within the past 14 days, and are unwell with any symptoms. People who are already well on the way to recovery or who are otherwise healthy are not eligible to participate in the trial.
Participants meeting the criteria can enrol on the study through the PRINCIPLE website (principletrial.org) or through their GP surgery.
Participation in the trial is entirely remote and no face-to-face visits are required of those taking part - just telephone or internet access - while participant packs will be couriered to patients’ homes. In addition to the clinical study team being at the end of the phone, participants’ GP practices will also be notified of the study and can discuss it with anyone taking part.
PRINCIPLE is trialling a number of low-risk treatments recommended by an expert panel advising the Chief Medical Officer for England. It is currently evaluating the effectiveness of usual care plus inhaled budesonide, which is a commonly inhaled anti inflammatory, compared to usual care alone.
The study is looking at patients who are especially vulnerable to COVID-19 because of age, or pre-existing health conditions such as heart disease or a weakened immune system. Evidence shows that people aged 50 years and over are at higher risk of developing more severe illness and complications.
Toni Symons, 56, agreed to take part in the PRINCIPLE study and was randomised to receive a drug called azithromycin, which is a commonly used antibiotic. Her participation involved taking a tablet twice a day for three days and completing a 28-day online diary of how she was feeling. She said: “I was very happy to say ‘yes’ after the GP talked me through what the study involved. With COVID being such a big problem, it’s more important than ever that we find out as much as we can so we can move forward.
“The more people who can get involved in studies like this, the more researchers can learn and identify treatments that work.”
Further details about the study can be found at www.principletrial.org or by calling the study team on 0800 138 0880.
Dr Paul Deffley, National Institute for Health Research Clinical Research Network Kent, Surrey and Sussex specialty lead for Primary Care and GP at Trinity Medical Centre, Hove said: “We know that the vast majority of people who test positive for COVID-19 don't require hospital treatment, so the biggest burden of the illness is in our community.
“Research being delivered in community settings is essential if we are to understand what are the best treatment options for patients. This is to ensure they have a speedy recovery and are less likely to suffer the complications of an infection that is clearly having a huge impact for our communities and frail populations. It is critical that people volunteer to participate in the trial and help us to further understand how best to treat this condition.”