Olivia Barnes, Senior Research Nurse at Sherbourne Medical Centre in Leamington Spa, discusses how COVID-19 is impacting the clinical trials she is working on.
Olivia Barnes is a Senior Research Nurse at Sherbourne Medical Centre in Leamington Spa. In this series of weekly posts she discusses how COVID-19 is impacting the clinical trials she is working on, as well as her work on studies in response to the virus.
Everything changed a couple of days ago when we got two COVID-19 studies and I'm now frantically working to get those set up. They are both RCGP (Royal College of General Practitioners) studies; one is on test kits where patients with symptoms of COVID-19, and the other is a randomized study for an anti-malarial for the over 50s. Both are entirely remote; for the testing, the patient will give verbal consent and then self-test, and for the randomized study, the patient gives an eConsent and completes their eligibility online. The only thing that has to leave the surgery is the drugs and the test kits.
I can't believe the speed that they’ve been set up. Instead of things following a nice linear program, everybody's having to work very, very differently and things that you expect in a certain time frame has totally changed. The speed at which they've been set up is very impressive - the randomized trial has been put together in days and weeks rather than months.
Looking to the future I would hope that this speed is going to continue with other studies. I think the UK has lagged behind, and despite the best efforts of the NIHR, it still seems to take an inordinate amount of time to get things up and running.
We are a small research department, there is only three of us - the Principal Investigator, myself and site coordinator, so one could drop out due to illness or self isolation, but if two dropped out it would be a bit dire. I work three days a week, but I'm quite prepared to come in the other days to get these two very important studies done.
"The speed at which they've been set up is very impressive - the randomized trial has been put together in days and weeks rather than months."
For everyone, we all feel in a state of suspended animation. It is personally very strange that I'm still coming to work and the roads are empty. It just all adds to the strangeness really.
The main thing that has been on my mind this week is protocol deviations. It's something we try our absolute hardest never to have normally, and yet the minute they are coming thick and fast. Things that are meant to be done in person, such as blood pressures, taking temperatures and the doctor listening to their chest - all that can't be. So we have a detailed telephone call and listen to what the patient is telling us without doing the physical checks that the protocol sets out.
When I'm sat down doing my paperwork, it doesn't sit very well with me, as it is something we strive very hard to avoid usually. Research is very black and white, so you've got to get it right and get it right first time. With any protocol deviations you must make sure you document everything very, very carefully to show that you are aware of the deviation and why it occurred.
We obviously want good data, and we want to do everything we possibly can in the studies, but at the end of the day, it's the patients’ safety that overrides everything.
For our study on COVID-19 testing, unfortunately the people who may have been eligible have had their symptoms for too long, so weren't eligible. The patient has to have a temperature and a cough, but the swabbing test must be taken within seven days of the first symptom.
So as soon as the doctor is happy they are eligible, I would get the test kit to the patient. I will either ask someone who does not live with the patient to collect the kit from the surgery and then post or if that is not possible I could take the kit to the patient myself and wait for them to take the swab, then take it straight to the Post Office.
We sent out over 2000 text messages this morning (Tuesday 14 April) for a randomized study for an anti-malarial drug as treatment for COVID-19 for the over 50s. It's the first time ever that I've sent out that many text messages so I really don't know what to expect. I've got enough medication for 16 patients, so that would be 32 in the study given that it is a 50-50 randomised trial, and if I get those, I can order more.
Anyone who wants to take part should reply with an email straight to the study centre, but in my past experience most people will still phone here to find out more because the texts are coming from us. The process is all done online; everything from consent to the daily questionnaires, so unfortunately if they don't have access to the internet they won't be able to take part.
"For everyone, we all feel in a state of suspended animation. It is personally very strange that I'm still coming to work and the roads are empty. It just all adds to the strangeness really."
Last week we sent two thousand text messages for the anti-malarial drug COVID-19 study – it is a 50/50 randomized split between those taking the drug and self-testing, and those just self-testing. Within a day we had two ladies who contacted the help desk and were eligible. One was allocated to the drug and one just to swabbing. We actually dropped the drugs and kits off to them because we were be able to do that on our way home, though the NIHR are co-ordinating courier services if we need them. It is always the first patients in any study when you find glitches, but all went reasonably well. It will be interesting to see the result, which will take about a week to come back.
And on the self-testing study we have had three patients and the first two came back negative. However, we haven't had any recruits this week so far for either study.
The study that we have had the best results on is one on serology testing, from the RCGP via Oxford University. It is for patients who had to be attending the surgery for a blood test – we couldn't approach anybody else other than people already having booked for a blood test here at the surgery. They have been given a one page patient information sheet and asked if they mind having an extra tube of blood taken for this research. The patients won’t get results and we won’t get results – it is purely to look at background immunity in the general population.
Of the first 26 patients to come into the surgery, 25 agreed to take part and I've had to order another 50 kits. This could not have happened without the help of our surgery HCA who sees all the patients for blood tests. In addition to her own work, she has helped with this project, taking verbal consent, labelling the samples and even taking the kits to the post office at the end of her shift.
People are quite happy to help the NHS and are quite altruistic - it's a lovely thing to see. I see it in my normal working day - we do a lot of research here at Sherbourne and our patients are very aware of that – and in general we don't have a problem getting volunteers even for a Phase II or early Phase III studies.
I’m also having to do some education myself around COVID-19 so I can help patients with background information. The World Health Organization has a really good page showing the difference between the serology testing - what they're trying to do and what tests are available.
We’ve now settled into a bit of a pattern - I don't like to use the old cliché, but it seems to be we now have a ‘new normal’ and a bit of a routine.
Every Monday I send an email to all clinical staff - and in fact at the minute it's everybody in the practice because the whole practice needs to be on board when you're doing research like this – to tell them what studies we’re doing and what numbers we've got, to keep it at the front of their mind. Obviously, I’m reliant on the partners or reception, who are taking the telephone calls, to then pass the patients’ details on to me.
Luckily very few of our staff have been off sick. We have quite a strict regime around opening the door and what the reception staff wear, and we have a very good cleaning regime after we've used our desks. Even our coffee breaks have been as per the social distancing guidelines. When patients come into the surgery, they ring a bell and then they come in one at a time. Very, very seldom is there anybody actually in the waiting room because they just come in as their appointment is due.
We were lucky, as we’ve been doing telephone triage for over a year, but I do know a lot of GP surgeries who weren't doing that have struggled. It takes a while to settle into it as it is a very, very different way of working for everybody – the reception staff, the patient and the doctor.
We’ve been told studies may restart soon, but nothing as of yet has begun. However, we have had our first patient on a study back in the building. He’s been in the study for a year and there were a lot of bloods to be taken, so from a study point of view, it was in the patient’s interest to come in. We asked if he would be willing to come to the practice and he was, but if the patient hadn’t of been happy, we would obviously have done the visit over the phone. The study team had made allowances and the advice was that if we could get the patient back in within a month of the planned visit to do the bloods, that would still be acceptable.
We had to see him wearing full PPE and then there was a lot of cleaning afterwards. In the past we had a dedicated research room with everything we needed, whereas now we’re only using two rooms to see patients in. So I have to do a bit more planning to make sure I take all my research equipment I need down to the room with me, so that once we were in, we didn’t have to come in and out. It is a very different way of working, but we have two more patients coming in next week and I’m going to ask them how they feel about being in a study during COVID-19.
With our COVID-19 studies, we’re continuing with the serology study and we now have 130 taking part in that and I’ve just ordered more kits. The anti-malarial treatment study we were taking part in has been replaced by the antibiotic Azithromycin. It remains a two-armed study with all patients being tested, but 50% will now get Azithromycin instead of the anti-malarial drug.
However, the other COVID-19 studies have been very quiet, with no new recruits. It is obviously great that there are far fewer cases of COVID-19 now, but from a research point of view I don’t know if they have enough numbers or not to be viable. Hindsight is a wonderful thing, but if something could have been set up with the 111 service that may have worked better to direct patients to us, but they were so inundated with calls.
Things have been much busier in the last few weeks, as one of the studies that was on hold has restarted. It is an observational study, following patients for a year for cardiovascular events.
For this study, obviously they've had to make amendments to do things by post. Questionnaires were either posted or emailed, and after the patient consents, they post it back for the Principal Investigator to check everything, counter-sign the consent, and then post it back out. So it is an awful lot of extra work. The patient doesn't have to come in at any time. They would have come in for a baseline visit and I would have tested blood pressure, weight and so on, whereas now there is an amendment to take the latest blood pressure and weight, as long as it is within a set timeframe. So it has been quite a challenge changing how we would have run it, but it's working - our target was ten, we've approached eight people so far and had four consent.
Hopefully some of the other studies will start again soon - lots of the Sponsors are tentatively asking how things are at the site and how prepared we are. We have got lots of guidelines from NHS England and are following an SOP from them, but for us it is the patients having the faith in us to be willing to come in and see us that is most important. Give it another month and I think we will be significantly busier.
We're still continuing with the COVID-19 serology testing study and people are still willing to give blood samples for research purposes. We're also going to send out another text message for the principal study we are working on to update patients that the study has changed from an anti-malarial treatment to the antibiotic Azithromycin. With COVID-19 incidents going down nationally, they are not getting the numbers for the study.
We've been approached about a COVID-19 vaccine study, but with restrictions in place, we're not sure how that will work, so we're going to have to think a bit more out of the box. With vaccine studies you're looking at large numbers of patients, regular visits, and patients having to stay in the surgery for significant time after first dosing, so it is going to be very challenging. We're keen to do the study, but logistically we don't know how it is going to work - we're going to have to think very differently in ways we've never considered before.
To find out more about the studies, visit the Sherbourne Medical Centre website.
