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Background

PRINCIPLE is a nationwide clinical study led by the University of Oxford to find COVID-19 treatments for the over 50-year-olds that can be taken at home. The aim is to find medicines that can help people with COVID-19 symptoms get better quickly and stop them needing to go to hospital. Health Data Research UK has supported the PRINCIPLE trial by enabling links across the datasets and gaining patient and public input.

How have people been involved?

“Anyone experiencing COVID-19 symptoms may be eligible to join the PRINCIPLE trial if they are aged over 65; or over 50 with an underlying health condition.

 

Recruitment is occurring through a variety of ways and across the entire UK. At the moment more than 1,000 GP surgeries are actively recruiting eligible participants. The COVID-19 Symptom Study is also helping to recruit, if someone reports symptoms in the app and they are in the eligible age ranges they will get a message inviting them to the PRINCIPLE trial. As well, if someone returns a positive Government COVID-19 test they will also be invited to the trial through a message or phone call from us. As well, there’s our website.

 

At the end of last year, we had recruited 3,000 participants – a phenomenal achievement in just 9 months.”

What difference is this trial making?

“I think the biggest thing with PRINCPLE is that we are looking to find a treatment for people with COVID-19 and at the beginning when we didn’t have anything, it was massive to think we could help to support people. Even now with the vaccine roll out which is amazing progress in such a short space of time, there will still be people who won’t be able to get the vaccine, or people who will still develop symptoms, so it’s really important we try to find a treatment that can reduce the risk of someone going to hospital, reduce the length of time they have symptoms, and make them feel better quicker! That’s what we want – no one wants to feel poorly.

The main outcome of what we are trying to do with this trial is to find that treatment that will help everyone, that is a low-cost, available treatment, while making sure we aren’t wasting NHS money. Even if we find treatments that don’t work at least we are finding that out and not wasting NHS money on them.”

What have the experiences been like for the people involved?

“The biggest difference, both from a clinical point of view, and for nurses and participants, is that we never meet any of our patients, which is unusual for us because we are so used to being really hands-on and seeing people face-to face. People can register and complete the forms online, or there’s a phone number they can call as well.

 

Most people we’ve spoken to are very keen to help. For the people that are taking part, when they register, we can’t guarantee which arm of the trial they are going into, they might get medication, or they might not. Regardless people understand they are contributing to fighting the COVID-19 battle.

 

We’ve had people tell us they think we’ve saved their lives; I think because we do have the time to talk to people and listen to people, and while we can’t give them clinical advice, we can support them through the trial process they are grateful they’ve had people listen to them. Particularly before Christmas we had a lot of people feeling as though they were alone, but we can support them and tell them they aren’t on their own and that we speak to hundreds of people a day with the same symptoms.

 

It’s not just about the question we are trying to answer, but the experience we give people. People definitely feel really positive about it.”

How often do trial participants speak to a nurse throughout their involvement?

“Everything is done remotely and we have tried to make this as burden free for the participant as possible. If a participant is really tech-savvy they can complete all the forms online and we courier out the packs. If they then complete their symptom diaries for the next 28 days we wouldn’t contact them at all. Occasionally there are times when we need to check what the patient meant by that answer so we would ring them. If they don’t complete their diaries for a number of days we would call, firstly to make sure they are okay and to see how we can support. Of course, participants can call or email us at any time and we are very happy to talk.”

What has it been like as a clinician?

“I don’t think I’ve ever worked on anything like this before. I’ve been in research for 9 years, always in primary care and the biggest thing is not being hands-on with patients. We are nurses first and foremost so that’s really unusual. Speaking for the team, we all feel like we are playing our part in the COVID-19 battle as well, we might not be on the front line, but we do feel like we are making a difference.

 

It’s been tiring at times, with the lockdown a lot of people were at home, but my clinical team we have been here at the office working long hours, it’s been tough. But that’s why we all come to work! It’s so huge that sometimes you can’t think too much about it, because it just blows your mind! We might not be one of the most heard of studies, but we are making our impact – something to be proud of, that’s for sure.”

What difference has it made being able to do a trial with a large cohort?

“The joy of this trial is that it’s a platform trial, so we can add in and take out things quickly. With studies with smaller numbers, we find you have to follow up with patients and complete the trial before results. With this we are getting feedback much quicker, there are teams in the background looking at the data as it is ongoing, finding trends and themes.

 

Logistically, keeping track of all these people is a bit of a military operation, but the more people we have the quicker we can find answers.”

What have you learnt that you will use again in the future?

“Lots. I think this trial has changed the way we will do research in primary care forever. Having access to summary care records is a huge achievement and the data is vital.

 

Prior to PRINCIPLE we weren’t granted access, which is huge because the time from a patient registering to us being able to randomise them has dropped dramatically. We have developed amazing relationships and working relationships with people that we haven’t worked with before. A lot of research happens locally or in set areas, but this trial is across the whole UK, so we’ve developed great relationships with our Welsh and Scottish colleagues. We will continue to build on these.”

 

As a team, we’ve learnt a lot about our own resilience. It’s been a huge learning curve for all of us and hopefully it continues, and we continue to develop. Going back to the patient experience, at the beginning I think we did underestimate our impact on people. The stories people tell us range from really sad, to really lovely. It’s all uplifting to know the effect we are having. We feel like we can take on any trial after this!

 

Sometimes you forget how much we’ve achieved and as a nurse the patients always come first, and their experience has been on the whole really positive and they feel as though they are really helping in their own way.”