AGILE is a ground-breaking clinical trial platform which aims to fast-track potential new COVID-19 treatments through early phase clinical trials and is testing multiple potential treatments in parallel. This means that new treatments can go through the important testing stages in a matter of months rather than years, while maintaining a high level of safety at all times.
We spoke to a patient who has taken part in one of the AGILE trials, and a research nurse working on another of the trials, to find out how they feel about being part of this ground-breaking research.
Cathy Barrow, 56, from Liverpool has been taking part in the AGILE trial of the oral antiviral pill molnupiravir after she tested positive for COVID-19 at the start of August, despite having had both her vaccinations.
She’s been telling us about contracting COVID, and her experience of being part of AGILE.
“At the start of the pandemic I was terrified,” says Cathy. “I suffer with Hashimoto disease which is a thyroid auto-immune disease, and as very little was known about COVID-19 it was frightening. But I once I’d had the double jab, I felt a lot more confident.”
But after her daughter came down with COVID-19, Cathy decided she needed to get tested.
“Although we had no symptoms whatsoever, both my husband and I had been spending time with our daughter and granddaughter, so we did a lateral flow test and there was a very faint line. We then went to get a PCR test which came back positive.
“Then I started getting a runny and blocked nose and a headache, and a couple of days later I felt a bit lethargic, and my taste and smell went. But luckily the symptoms were not too serious. It was just like an inconvenient head-cold.”
Just after testing positive, Cathy was called by a doctor from the AGILE clinical team in Liverpool to ask if she would be interested in taking part in the trial.
“By this time, we were crawling the walls in isolation, so any excuse to get out of the door was fine by me! I told the doctor that my husband had also tested positive, and he told me we could both take part.
“We were told that the trial would involve some tests such as an ECG, taking some swabs and some blood, checking our weight and height, and filling in some questionnaires. It sounded like a bit of an MOT really and I was quite happy with that. Then we would be given some tablets to take and would have to come back for a couple more hospital visits.”
Cathy, who works as a train guard for Mersey Rail, says being involved in research into a potential new COVID-19 treatment is exciting.
“It feels like you’re giving something back to be honest. Because if it wasn’t for people who took part in the trials for the vaccines, we wouldn’t all be vaccinated. They trialled that to help me, so why wouldn’t I trial a treatment that could help someone else?"
Cathy and her husband, Dave, had their last hospital visit for the trial at the start of September.
“I feel fine now. My COVID illness was thankfully relatively short and as I’d had the vaccines, I think it meant my symptoms were a lot less severe than they could have been. And maybe the trial treatment I was on had an effect too. Of course, I don’t know at this stage whether I had the real treatment or the placebo though, because we don’t get told.”
Cathy is now about to embark on a new career as she begins training to be a train driver. And she says being part of the trial has been a positive experience.
“I would say to other people who are approached to take part in one of the AGILE trials, or any COVID-19 trial, that if you can take part and you feel comfortable doing it, then go for it.
“Hopefully this trial will have a positive outcome and the team will find what they are looking for. It feels good to be a part of something positive in relation to COVID-19.”
It feels like you’re giving something back to be honest. Because if it wasn’t for people who took part in the trials for the vaccines, we wouldn’t all be vaccinated. They trialled that to help me, so why wouldn’t I trial a treatment that could help someone else?
Daiana Ferro, 32, is a research nurse at the NIHR Southampton Clinical Research Facility (CRF) and is working on the AGILE trial of a first-in-human antibody treatment.
She told us how she came to be a research nurse, about working in ICU during the pandemic, and how it feels to be part of clinical trials for new COVID-19 treatments.
“When I started my nursing degree at home in Brazil in 2013, I knew that I wanted to become a research nurse. So, throughout my studies I used my extra time to get experience working on trials and helping with data entry.”
“When I came to the UK, while my nursing registration was being processed, I applied for a research assistant’s job and sent two years in a pathology lab to boost my knowledge of trials in the UK.”
Once Daiana had her UK nursing registration, she got a job in the intensive care unit at South Tees University Hospital in Middlesbrough during the second and third waves of the COVID-19 pandemic.
“It was a very difficult time; a brutal time” says Daiana. “We lost a lot of patients. It was particularly difficult when a patient was deteriorating but was still awake. They knew about everything; they could see what was going on around them. We saw a lot of patients dying alone, so we were their families at that time.”
“When I saw the AGILE job in Southampton, I knew I wanted to help run this trial to try to improve people’s lives and to offer a proper treatment for COVID-19.”
Daiana now works on the CST5 trial of a monoclonal antibody to treat COVID-19. This is a first-in-human trial of a drug which researchers hope can not only neutralise the SARS-CoV-2 virus, meaning patients are less likely to be admitted to hospital with severe symptoms, but also trigger a long-lasting immune response to further control the infection.
“When we get the list of confirmed COVID-19 cases, my job is to call eligible patients to invite them to join the trial. Some are obviously very scared and don’t want to be part of it, which is fine. It’s often young people who are interested in the research and are keen to take part.”
“When those who consent come in for the treatment, they spend 24 hours with us. Because this is a new drug, we need to make sure there are no side effects, and the patient is safe. They then have follow-up visits over the next 6 months. It is quite complex, but it’s crucial to make sure that the patient is completely safe and well through the whole process.”
Phase I of the trial to test the safety and correct dose of the new antibody is now almost completed, and a Phase II trial to test it against an existing antibody treatment and a placebo is in development.
And Daiana says it is fantastic to be involved in the AGILE trial.
“I know that I am just a little part of this huge mechanism, but I’m very happy to be part of this research. And gaining more knowledge of these monoclonal antibodies is not just about COVID, it will be helpful for future trials in future diseases that we may be struggling with."
I think as nurses, we have a duty to deliver the public our best and deliver it with dignity and with hope. It’s more than just giving medication or treating an illness. It’s about how we can respond to a critical situation like the pandemic and hopefully bring about the new treatments that will keep people safe in the future.
Ines Rodrigues leads the research nursing team at the Southampton CRF:
“When COVID came along in March 2020, it changed pretty much everything we were doing in terms of research. We started doing a lot of the vaccine trials, which was a huge team effort. When AGILE started almost a year into the pandemic, it was exciting that the Southampton CRF was one of the sites doing the trial. Daiana was pretty new with us, so it was amazing the way she took on the study and ran it.”
“I am so proud of my team and all the work we do together. When the first paper came out saying the Oxford vaccine was effective and was going to start being administered, we felt that we had done something special and were part of history – one day I can tell my grandchildren or great-grandchildren that I was part of that. And it’s the same with AGILE. We are part of this amazing research.”
And it’s a feeling echoed by Daiana:
“I think as nurses, we have a duty to deliver the public our best and deliver it with dignity and with hope. It’s more than just giving medication or treating an illness. It’s about how we can respond to a critical situation like the pandemic and hopefully bring about the new treatments that will keep people safe in the future.
AGILE is a ground-breaking collaboration between researchers from the NIHR Southampton Clinical Trials Unit at the University of Southampton, the University of Liverpool, Liverpool School of Tropical Medicine, NIHR Liverpool and Broadgreen Clinical Research Facility at the Royal Liverpool University Hospital, University of Cambridge and the UK Clinical Research Facility Network.
To find out more about AGILE, visit www.agile.net