Hastings House Medical Centre is involved in a national research project, coordinated by the University of Oxford, exploring potential treatments for COVID-19 (coronavirus). It is called the PRINCIPLE study.
In addition to the information below, a participant information leaflet is available. An easy-to-read version of the leaflet is also available.
Once you have read the information below, if you are eligible, you can volunteer for the trial using the green button below:
About the trial
The risk of complications from COVID-19 is generally greater in people aged 50 years and older with underlying health conditions and in those aged 65 years and older. While most infections either do not cause symptoms or are mild, this new viral infection can lead to significant medical problems, hospitalisation, and sometimes death.
Most of the infections are being managed in the community and it is essential that we identify treatments that help to reduce the progression of the disease and therefore the need for hospital admission.
About the trial
As yet, there are currently no known treatments for COVID-19 which have been proven to be effective. Our trial aims to evaluate potential treatments as they are identified. To be able to do this, we aim to test one or more suitable, potential treatments for COVID-19, as soon as they become available.
We want 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 that may simply put them at unnecessary risk of side effects.
In the first instance, we are evaluating a drug called hydroxychloroquine. This is a drug that is well known and has been used for many years around the world for conditions such as malaria and arthritis, but is not currently used to treat this kind of infection.
Aim of this trial
We aim to find out whether selected treatments given to those at higher risk of becoming more ill when they are infected with COVID-19 can help reduce the need for hospitalisation and the length of stay required, helping people recover quicker and with fewer complications.
All people included in the study will be provided with a test for COVID-19 where possible. Some will receive the medication we are testing and some will be allocated to current usual care without the medication we are testing.
Who can take part?
Participation is entirely voluntary. It is up to you to decide whether to take part in the trial or not.
The decision to not take part will not affect the standard of care you receive from the NHS in any way, now or in the future.
The trial is open to those aged 50 to 64 who are experiencing symptoms that are likely to be caused by a COVID-19 infection and have at least one of the following conditions:
- A known weakened immune system because of a serious illness or medication (e.g. chemotherapy);
- Known heart disease or high blood pressure;
- Known asthma or lung disease;
- Known diabetes not treated with insulin;
- Known mild hepatic impairment (liver disease);
- Have previously had a stroke or have known neurological problems.
People aged 65 or over even without other illnesses who have symptoms of COVID-19 are also eligible to take part.
Symptoms of COVID-19:
- a new, continuous cough
- and/or a high temperature.
These symptoms need to have been experienced for fewer than 14 days.
What does the trial involve?
All people included in the trial will be provided with a test for COVID-19 where possible.Briefly, participants will then either receive the trial treatment we are testing or they will receive current usual best care and advice but without the medication we are testing. All participants will be able to take medicines like paracetamol, whatever study group they are in, but all will be asked not to take any experiment or unlicensed drugs for their illness, unless it is issued to them as part of the trial. Participants will also be asked to answer some questions each day online for up to 28 days telling us about any symptoms you might be experiencing and how well you are feeling.
Why take part?
By taking part in this trial, you will be contributing towards the understanding of how we can treat COVID-19 and how the symptoms progress.This may or may not help to reduce the duration and severity of symptoms when people fall ill. All participants will also receive a swab, and be told if the swab is positive or not for COVID-19. We also hope to reduce the burden on the NHS.
How do I take part?
If you'd like to take part in the study you should complete the screening form - please click here.