COVID-19 Treatment Research Trial

Pembroke Medical Group have been selected to host a research trial into treatments for COVID-19 this is being run in conjunction with Platform for Randomised trial of INterventions against COVID-19 In older peoPLE (PRINCIPLE)

About the trial

The PRINCIPLE trial is a national priority trial to find treatments for COVID-19. It is now a country-wide trial, and the only national priority platform trial in primary care.

The trial is being run by the University of Oxford and is funded by UK Research and Innovation and the Department for Health and Social Care through the National Institute for Health Research.

Aim of this trial

We aim to find treatments for COVID-19 for people in the community who are at higher risk of complications. We want to find medicines that can help people get better quickly and stop them needing to go to hospital.

In the first instance, we are testing 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 COVID-19

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 people aged 65 or over even without other illnesses who have symptoms of COVID-19.

It is also 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.

Symptoms of COVID-19:

• a new, continuous cough
• and/or a high temperature.

These symptoms need to have been experienced for fewer than 15 days.

What does the trial involve?

Briefly, participants will need to answer some questions online.

They will be able to nominate a ‘study partner’ (family, friend, carer) to help them with the study.

A GP, or a study nurse or doctor, will also check their medical notes to make sure it is safe for them to be in the study.

They will either receive usual care, or usual care and a study drug which will be delivered from their GP.  All study drugs are already widely used in the NHS and have been approved as safe for use in this study. The study will use a computer programme to decide by chance whether they get the drug or not.

They will have a swab done to test for COVID-19, if swabs are available.

If they can access the internet, for the next 28 days we would like them to complete an online diary of their symptoms and medical care they have received. If they can’t access the internet, the trial team can phone them every one to two weeks to get this information.