Heartbeat: Primary care study into COVID-19 launched in the community
June 19, 2020
There is now a treatment trial open for patients being seen by GPs in Your Health Partnership (YHP) called PRINCIPLE. This includes residents of care homes who are able to consent to participate.
The trial is open to people with COVID-19 symptoms who are over 65 with or without other health problems and for patients who are between 50 and 64 who have one of a number of pre-existing health conditions.
The trial design for PRINCIPLE allows the study to turn on and off trial treatments. The antibiotic azithromycin randomisation has been added into the study, in response to concerns regarding the use of hydroxychloroquine in patients with COVID-19.
Dr Abdul Tabassum, from YHP, is the principal investigator for the study. He said: “PRINCIPLE is a very important primary care-based trial, in areas where local health systems are under immense pressure. With a background of high prevalence of chronic disease and multiple co-morbidities, it puts many of our older patients at increased risk from COVID-19. The trial aims to identify treatments that can help people get better and keep them out of the hospital by treating them in the early stage of the infection.
“Experience from other participating practices show that the enrolment process is quite easy and straightforward. I am hoping that our patients will be open to participate and help to find the effective treatment to beat this disease which is the cause of so much death and misery in the world.
“It’s very important that everyone working in the community and primary care is aware of this study. Even more important is to inform patients about the study and give them information to enrol in the trial. They can do this very easily by directing patients to the PRINCIPLE trial contact details.”
Patients will need to answer a few simple screening questions and the study team will do the rest. Dr Tabassum added: “I feel that we have worked well with the Trust. The research and development team (R&D) has played a key role to get YHP registered on the trial. I am looking forward to working with the team.
“We are hoping that most patients will have someone who will be able to collect the drugs and swabs from Regis Medical Centre. If they are not able to do this, we will be asking colleagues from the Trust’s brigades to help and deliver the medication to the patient’s home. These arrangements have been put in place to make it easier for patients to participate.
“I would like to ask the help from every colleague working in the community and primary care from nurses, HCAs, and doctors to occupational therapists and pharmacists, to encourage patients to take part in the trial. If we work as one team, we can help our patients and the NHS.”
If a patient is registered with YHP and meets the criteria for this study they may get a text inviting them to join if they develop COVID-19 symptoms. 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.
The Trust is also recruiting to several other treatment and observational studies. The RECOVERY trial is looking at a range of drug treatment options for patients who are admitted to hospital with COVID-19. It is a rapidly changing study so that it can assess a range of treatments quickly.
REMAP-CAP is a drug trial for patients who are more poorly and requiring critical care. It is a complex treatment trial looking at lots of types of treatments simultaneously. ATOMIC2 is due to open shortly and will be recruiting patients who attend the hospital but do not require admission. Several other studies and registries are collecting data and samples to improve the understanding of the genetics of COVID-19 and how it impacts on patients.