Platform Randomised trial of INterventions against COVID-19 In older peopLE – The PRINCIPLE Trial
Evaluating potential treatments for COVID-19 in older people.
Coronavirus disease 2019 (COVID-19) can be more severe in older people, and people with underlying health conditions. At the moment, there are no specific treatments that we know definitely work against COVID-19.
We urgently need research to find medicines that help people get better quickly and stop them needing to go to hospital.
About the trial
The PRINCIPLE trial platform 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 designed to test a range of treatments in the community, with treatment arms that can be stopped, replaced or added.
PRINCIPLE is currently evaluating usual care alone versus usual care plus azithromycin. Azithromycin is a commonly used antibiotic that is anti-inflammatory, treats community-acquired pneumonia and bacterial chest infections, and has antiviral properties.
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.
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.
To take part, you need to be:
1. Experiencing symptoms that are likely to be caused by a COVID-19 infection, for fewer than 15 days:
- a new continuous cough – this means coughing a lot for more than an hour, or 3 or more coughing episodes in 24 hours (if you usually have a cough, it may be worse than usual),
- a high temperature – this means you feel hot to touch on your chest or back (you do not need to take your temperature),
2. You have had a positive test for SARS-Co-V2 infection which was taken fewer than 15 days ago,
AND are unwell with symptoms of COVID-19. These symptoms may include, but are not limited to:
- shortness of breath,
- general feeling of being unwell,
- muscle pain, diarrhoea,
- vomiting, fever and cough,
and you must have had them for fewer than 15 days.
The study is for people with ongoing symptoms. People who feel they are already well on the way to recovery should not take part.
3. You also need to be aged over 65
or 50 to 64, with at least one of the following conditions
- weakened immune system due to a serious illness or medication (e.g. chemotherapy),
- heart disease or high blood pressure,
- asthma or lung disease,
- diabetes not treated with insulin,
- liver disease,
- stroke or neurological problem,
What is a continuous / persistent cough?
A new, continuous cough means coughing a lot for more than an hour, or 3 or more coughing episodes in 24 hours (if you usually have a cough, it may be worse than usual).
How do I tell if I have a high temperature without a thermometer?
A high temperature means you feel hot to touch on your chest or back (you do not need to measure your temperature).
What does the trial involve?
If selected as a participant, you will need to answer some questions online or on the telephone (0800 138 0880) to check you are suitable, and provide consent.
You will be able to nominate a ‘study partner’ (family, friend, carer) to help you with the study.
Your GP, or a study nurse or doctor, will also check you medical notes to make sure it is safe for you to be in the study.
You will either receive usual care, or usual care and a study drug which will be delivered from your GP, or directly from the research team. 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 you get the drug or not.
You will have a swab done to test for COVID-19, if swabs are available.
If you can access the internet, for the next 28 days we would like you to complete an online diary of your symptoms and medical care you have received. If you can’t access the internet, the trial team can phone you every one to two weeks to get this information.
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. We also hope to reduce the burden on the NHS.
To take part, or for more information please click here.
If you have not already read the Participant Information Leaflet you can download it by clicking the link below.
Click here to download the PRINCIPLE Participant Information Leaflet
There is also an illustrated summary of the Participant Information Leaflet that you can download by clicking the link below:
Click here to download an illustrated summary of the PRINCIPLE Participant Information Leaflet
Click here to access translated versions of the PRINCIPLE Participant Information Leaflet