COVID-19: how nurses are taking the lead in the quest to find a vaccine and treatment
The UK’s research nurses are on the front line of trials at an unprecedented scale and pace
- Research nurses have been working at an accelerated scale and pace alongside clinical teams to set up research trials during the COVID-19 crisis
- Challenges have included recruiting participants, working under tight isolation and infection control measures and managing redeployment of staff
- An overview of the COVID-19 research programmes that are under way in the UK and the progress they have made, including those where nurses are also participants
More than 100,000 people with COVID-19 have been treated in hospital during the pandemic.
Clinical staff, including nurses, have played a crucial role in caring for and supporting them.
Research nurses have been working on coronavirus vaccines and treatments
But alongside these staff is an army of research nurses whose role, while less visible, has been just as important.
UK-based vaccine trials have been set up
The network of 5,000 research nurses in the NHS has been helping the health service trial new treatments, develop vaccines and understand more about the new disease.
Association of UK Lead Research Nurses (AUKLRN) chair Heather Iles-Smith says it has been ‘incredibly busy’, with trials set up at record pace.View our COVID-19 resource centre
Other research projects have been put on hold
Almost overnight, existing research programmes were paused at the start of the pandemic – apart from those where this would have detrimental effects for ongoing patient care.
In total, nearly 50 different COVID-19 treatment trials have been prioritised by the National Institute for Health Research (NIHR) for NHS trusts to focus on – some involving multiple treatments.
Meanwhile, human trials have begun in two UK-based vaccine programmes – one run by Oxford University and one by Imperial College London. The Oxford vaccine trial now involves 18 different NHS trusts.
On top of this there is work being done on antibody testing, genetics research and observational studies.
What are the UK’s COVID-19 research programmes?
The National Institute of Health Research (NIHR) has identified a number of priority trials that NHS trusts have been asked to take part in. These have been looking at whether a range of existing treatments, from blood thinning drugs to anti-inflammatory treatments and antiviral medication, can help. The largest is the RECOVERY trial, but other major studies include REMAP-CAP, which is focused on intensive care patients, and ACCORD. Strong evidence has been found for the effectiveness of the steroid dexamethasone in treating patients with COVID-19. Research from the RECOVERY trial published in June showed the steroid cut the risk of death by a third for patients on ventilators and a fifth for those given oxygen. It is now being used as a front-line treatment.
Two UK-based vaccine trials have been set up. The first one to get under way is run by Oxford University. Human trials started in April, with 1,000 participants recruited by May. The next phase will see another 10,000 recruited across 18 sites. Human trials for the second vaccine, developed by Imperial College London, which started in late June. There are about 150 other vaccine trials around the world in various stages of development.
Research nurses have been seconded to work on the government’s antibody test programmes. REACT-2 has been looking at the effectiveness of self-administered tests. Members of the public and front-line health workers have been recruited. The second programme is called SIREN and focuses on the antibody test developed by Roche that is being offered to healthcare staff across the country. The aim is to recruit 10,000 healthcare workers and regularly monitor those that have antibodies over the course of the year to see if they become infected.
Research nurses working with clinical research practitioners have taken samples and recorded data as part of observational studies. One of the largest is the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) scheme, a global network, which has tracked the spread and behaviour of COVID-19 since it first emerged. Hospitals in England, Scotland and Wales have taken part.
Blood plasma transfusions
NHS Blood and Transplant is coordinating a programme that will look at whether blood plasma transfusions could help people with COVID-19. The theory is that antibodies in the plasma of people who have been infected could help patients who are struggling with the disease. Blood is being collected and transfusions have started at a number of sites.
A Genomics England and Edinburgh University-led study is collecting DNA from intensive care patients as well as those with only mild to moderate illness to see what role a person’s genes play in the chances of them getting seriously ill with the infection. More than 160 hospitals are involved.
Research projects up and running within weeks
Dr Iles-Smith, who is also head of nursing research and innovation at Leeds Teaching Hospitals NHS Trust, says these efforts represent research at an unprecedented scale and pace.
‘Research nurses have had to set up and recruit patients within a matter of weeks, whereas it normally takes months to get a trial off the ground and recruit the first patient.’
But she says it has meant there have been some ‘real challenges’ that have had to be faced, from staffing redeployments to coping with the tight isolation and infection control measures introduced on wards and in intensive care.
‘In some trusts, we have had to up-skill research nurses to deliver drugs intravenously – many are only used to giving drugs orally. In other areas they have engaged clinical nurses to give the drugs and take samples and hand them to research staff.
‘But that is not without difficulties. Patients have been in isolation areas so staff have taken the samples to the door and dropped them in a bag that is then sealed.
‘Phones and tablets have been used to scan consent forms because they have not been able to be taken out of the isolation areas.’
Collaborations between clinical teams and researchers
Dr Iles-Smith says the way clinical and research teams worked collaboratively has been ‘really impressive’.
‘It has brought them together in a way that has not always happened. I've been on wards and in critical care and staff have been really interested in what we are doing.’
Nowhere has that been clearer than at the University Hospitals of Leicester NHS Trust.
lab-confirmed cases of COVID-19 were recorded in the UK as of 23 June 2020
More than 600 patients – thought to be the highest from a single trust – were recruited to the multi-drug RECOVERY trial, the UK’s biggest treatment trial and the source of the recent breakthrough with the steroid drug dexamethasone.
Key to the success, says the trust’s nursing and midwifery head of research Antonella Ghezzi, is the fact research nurses and clinical staff worked side by side across the trust’s three sites, even in intensive care.
‘We’ve had a close working relationship with clinical staff. I think COVID-19 has meant we have had a clear, shared goal,’ says Ms Ghezzi.
‘Clinical staff were trying to treat patients who were really struggling because of this new disease. They understood we needed to try things and find a way of treating these patients.
‘My research nurses were on the wards, working alongside the clinical staff.
‘The consultants would identify which patients to put in which arms of the trials. They would talk to families, but the patients were so acutely ill they could not give consent. When they recovered a little and were awake we would have to get consent from them.’
Clinical and research staff have also come together in a different way to work on vaccine trials.
Phase one of the Oxford University trial saw more than 1,000 participants recruited – and they will be followed by another 10,000 in phase two.
Clinical staff, including those working in intensive care units, emergency departments, hospital wards and in the community and care homes, are among those coming forward to be participants.
Nurses are being asked to participate in trials
Vaccine programme leader Sarah Gilbert says staff, including nurses, are being asked to play a crucial role because rates of infection have fallen so low in the UK.
‘Unless some of the trial participants become infected we cannot know that the vaccine is effective,’ Professor Gilbert says.
‘So we are focusing on vaccinating healthcare workers as they have the highest rates of infection.’
‘Research nurses have been working 24/7 – nights and weekends – alongside clinical staff. Working at this pace, setting up trials in a matter of weeks is not normal. But the team has responded amazingly’
Helen Jones, head of research nursing, Royal Free NHS Trust
Alongside this, nurses and other staff are coming forward for antibody tests and then being monitored to see how long any immunity lasts, while staff who have been infected are also donating blood plasma under the NHS Blood and Transplant programme to see if transfusions can help people who are infected fight off the virus.
But, as with clinical staff treating patients, the impact of being on the front line of the pandemic is taking its toll on research staff.
The AUKLRN has been running fortnightly telephone calls for members to provide peer support as well as share best practice.
Mental strain for research nurses redeployed to intensive care
Ms Ghezzi says the last few months have been very hard for staff. Some of her 90-strong team who had relevant experience were redeployed to clinical work in intensive care.
‘For those nurses who have gone back, there has been an obvious mental strain. But a lot of our nurses have been working in intensive care for the research work – and they are affected too.’
Royal Free NHS Trust head of research nursing Helen Jones says she has also had to juggle with redeployment.
people have been recruited to the Oxford human vaccines trial
‘As soon as it became clear COVID-19 was spreading, I looked at the team to see who had the necessary experience. Eight went to work in intensive care and spent nearly two months there.
‘The team has worked incredibly hard. You have to remember there was no set treatment for COVID-19 so patients have had to participate in trials to access treatment.
‘Research nurses have been working 24/7 – nights and weekends – alongside clinical staff.
‘Working at this pace, setting up trials in a matter of weeks is not normal. But the team has responded amazingly, working above their contracted hours to do the best for patients.’
‘The pace and scale of the research is unprecedented’
Susanne Fagerbrink is at the centre of vaccine research in the UK.
Imperial College Healthcare NHS Trust was one of four sites involved in the first phase of the Oxford University trial – and has now started developing its own vaccine.
Ms Fagerbrink has played a key role as lead nurse for the trust’s National Institute for Health Research clinical research facility.
She says: ‘We have had to completely transform the way we run trials in terms of getting participants in and out. We are adhering to social distancing and have reconfigured our spaces with separate entrances and exits.
‘We are seeing many more people – about 60 a day when it used to be 20 or so before this. The pace and scale of the research is unprecedented.
‘A lot of our other work has had to take a back seat. We hope in the future we will be able to get back to it but all the attention is understandably on COVID-19. I’ve never known anything like it.’
More than 40 health staff came forward to be participants in phase one, with 37 going on to be vaccinated.
‘The response has been very good. It is difficult for health staff – they are in hospital all day and then we are asking them to come back to take part in the study.
‘Participants had to stay an hour for observation and then kept diaries that recorded their daily temperature. If they develop symptoms, they have to return and do a swab test, although this has not happened.
‘There is a follow-up visit at 28 days then two or three more until day 365.
‘But staff understand why it is important and they want to help.’