THANK YOU FOR YOUR INTEREST IN THE PRINCIPLE TRIAL. PRINCIPLE IS NOW PAUSED TO NEW REGISTRATIONS.
YOUR INTEREST AND CONTRIBUTION TO THE PRINCIPLE TRIAL IS GREATLY VALUED. THANK YOU FOR HELPING US IN OUR SEARCH TO EVALUATE IF TREATMENT ADMINISTERED EARLY IN THE COURSE OF THE COVID-19 ILLNESS CAN HELP THOSE AT HIGHER RISK RECOVER QUICKLY, WITHOUT THE NEED FOR HOSPITAL ADMISSION.
PRINCIPLE is now paused to all new registrations
The PRINCIPLE Trial is entirely remote. You can participate from the comfort of your own home from anywhere in the UK with no face-to-face visits required.
There are several steps to joining from home. The first is answering a few screening questions to assess your eligibility.
There are different questionnaires depending on where you live in the UK.
Further details about the study are below.
As a lay person I welcomed being involved with the PRINCIPLE trial because I would prefer not to get to hospital in the first place! I am, therefore, extremely grateful to the research team for developing this project and, hopefully, finding some fairly simple method to reduce the effects of the virus.
Ms Carol Green, Member of the PRINCIPLE Independent Trial Steering Committee
Coronavirus disease 2019 (COVID-19) can be more severe in older people, and people with underlying health conditions.
We urgently need research to find medicines that help people get better quickly at home and stop them needing to go to hospital.
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.
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 favipiravir versus usual care plus ivermectin. Favipiravir is an antiviral drug used to treat influenza, (the favirpriavir arm is temporarily on hold). Ivermectin is an antiparasitic drug used to treat a range of infections.
Both our favipiravir and ivermectin arms of the study are open to those eligible and aged over 18.
PRINCIPLE 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 and Care Research.
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.
People who have received the vaccination are still eligible to join the PRINCIPLE trial in search of treatments.
To take part, you need to:
1. Have had a positive test for COVID-19, AND are unwell with symptoms of COVID-19 which have started in the last 14 days. These symptoms may include, but are not limited to:
- 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),
- a loss of, or change in, normal sense of taste or smell
- 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.
2. Be aged 18 and over
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).
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 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.
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.
It's really rewarding and exciting to be part of a trial where we are asking the general public to help find potential COVID-19 treatments. No face to face visits are needed, just internet access and participant packs will be couriered to you at home. In addition to our clinical study team being at the end of the phone, your GP practice will also be aware of the study and can discuss it with you.
Dr Emma Ogburn, Director of Operations, Primary Care Clinical Trials Unit
You can also telephone the study team on 0800 138 0880 to ask questions and for further information.
If your GP practice is participating, you are welcome to contact your GP first to discuss your suitability for joining the trial. Click here to see if you GP practice is participating. If your GP practice is not participating, you can still call the study team using the number above or join the study using the links below.