Published: 05 December 2020
Over six hundred thousand participants (629,676) from across the UK have now taken part in NIHR-supported urgent public health research into Covid-19, in just over eight months.
As soon as the potential impact of the Covid-19 global public health emergency was realised, the NIHR acted swiftly to roll out and deliver a range of urgent public health research into the disease. From the outset, the NIHR has been working closely with the NHS and devolved nations - in addition to the global life science industry - to ensure as many patients as possible right across the UK can benefit from the latest innovations in science and medicine.
The vast numbers of participants involved in NIHR-supported Covid-19 studies shows the remarkable national effort to tackle the pandemic - with tens of thousands of people volunteering to participate in this vital research in such a short space of time. However it is vital that this momentum continues, alongside recruitment of volunteers to non-Covid research.
Since the first studies opened, the NIHR has supported the rapid set-up and delivery of 73 urgent public health studies into Covid-19 - investigating a range of potential treatments, vaccines, observational studies to learn more about the disease, as well as research into new diagnostic technology. NHS hospitals have played a vital role in delivering studies at pace and scale, enabling hospitalised patients to benefit from the latest therapeutics against Covid-19 - in addition to helping tens of thousands of people gain early access to vaccine candidates through trials running across the country.
NIHR and NHS supported research has already led to the world's first effective Covid-19 treatments - corticosteroids dexamethasone and hydrocortisone. Many more new studies, investigating some of the world’s most exciting Covid-19 treatments and prophylactics to prevent disease, are continually being added to the NIHR’s urgent public health research portfolio. These include cutting edge studies into new monoclonal antibodies, inhaled antiviral treatments, and a range of promising potential vaccine candidates.
Despite achieving this impressive recruitment milestone - the NIHR is stressing the need to maintain the speed of recruitment and the high uptake of participants to Covid-19 research. To ensure that ongoing and future studies are sufficiently powered to establish the very best vaccines that will work for as many people as possible - while ensuring the UK and other countries have a range of safe and effective products - it is vital that healthy participants continue to volunteer for these vaccine studies. While to speed up the development of treatments for Covid-19, large numbers of patients are still needed to take part in the range of NIHR-supported therapeutic intervention studies.
Health Secretary, Matt Hancock said:
“The scale at which research into treatments for Covid-19 has taken place in the UK is unparalleled, and the determination for the country to come together to beat this virus is extraordinary.
“I want to thank every single person – from staff members to participants - who have taken part in this research. Everyone’s involvement has provided a vital link in the chain to help us better understand this virus and I am confident we will find a resolution through the ingenuity of science.
“We understand this virus infinitely more than at the start of this pandemic and each of us must continue to look at what role we can take. By coming together and using our scientific prowess, we will prevail.”
UK Chief Medical Officer, Professor Chris Whitty said:
“The willingness of the UK public to participate in Covid-19 research has been inspiring. Science is the only way out of this pandemic, it will find new ways to prevent and treat the virus and this will allow us to gradually return to normal life. This science cannot happen without those who volunteer to take part in research.
“The NIHR, as part of the wider UK research infrastructure, has been key to the UK’s success in delivering research with actionable findings, which have had an impact on the treatment of Covid-19 patients in the UK and around the world.
Dr William van’t Hoff, Chief Executive of the NIHR Clinical Research Network said:
“We want to sincerely thank every single one of the half a million participants who have volunteered to take part in Covid-19 urgent public health studies. Taking part has been vital to advancing the development of safe and effective treatments, tests and vaccines to tackle the pandemic. Your contribution has enabled us to make huge progress against the disease. My thanks also to the many staff in the NHS who have partnered in supporting Covid research - its this synergy between research and care that underpins the successes we have together achieved.
“But for all of the progress we have made so far, coupled with the early positive results from the vaccine trials, it is vital that people continue to take part in the wide range of research the NIHR is supporting. Our support for delivering urgent public health research is as important as ever, given the high infection rate, large number of admissions and indeed deaths. We need more effective treatments, and better diagnostics to help people affected by this, but critically, to help the NHS manage this devastating infection. For that, we still need many thousands more participants to continue to volunteer for these vital studies."
“With the UK in the midst of the second wave of Covid-19 infections and hospital admissions continuing to rise, it is now more important than ever for people to seriously consider whether they could contribute.”
Sir Simon Stevens, Chief Executive of the NHS, said:
“Helping so many participate in vital and urgent Covid-19 research is a phenomenal achievement by scientists and clinicians across the NHS. The speed and flexibility shown in these impressive studies now also should become the 'new normal' across the health service for wide ranging research on many other health conditions."
Unprecedented pace and scale
The total number of participants involved in NIHR-supported Covid-19 urgent public health research has soared from 100,000 in June, to well over half a million today. This unprecedented speed of recruitment and the dramatic increase in enrollment over recent months is testament to world-leading research infrastructure in the UK, but also the willingness of people to participate in vital Covid-19 studies - against a backdrop of rising community infection rates and hospital admissions.
Recruitment numbers have also been boosted significantly over recent months by the roll-out of large-scale phase 3 vaccine studies across the UK; alongside a huge number of participants taking part in observational studies - including the NIHR-supported ONS Covid-19 infection survey.
Highest priority research: Vaccine, prophylactic and therapeutic platform trials
So far, 46,009 participants have taken part in the Chief Medical Officer’s highest priority category of urgent public health research - which includes vaccine and prophylactic studies (as prioritised by the Vaccines Taskforce), in addition to the four main therapeutic platform trials supported by the NIHR.
The highest priority therapeutic platform studies, which include RECOVERY/RECOVERY+, PRINCIPLE, and REMAP-CAP, have already led to the development of life saving treatments in the case of corticosteroids for hospitalised patients.
The more participants recruited, the quicker the evidence can be established. But although 176 hospital sites have recruited 19,000 participants to the RECOVERY study alone - making it the world largest trial of its kind - there is still much more to do.
Giving evidence to the Commons Science and Technology committee in November, Prof Peter Horby, Chief Investigator of RECOVERY told MPs that the study is currently “only recruiting about 10% of all patients admitted to hospitals”. To ensure the effectiveness of the treatments being investigated through the trial can be established as soon as possible, Horby added “if we doubled the recruitment, we’d get an answer in half the time”.
Covid-19 vaccine trials
So far, some of the world’s most promising vaccine candidates are being investigated through NIHR-supported studies. Tens of thousands of people have already been vaccinated across the UK through these phase 3 trials. The pace and scale of recruitment is set to increase even further over the coming months - while other promising new vaccines will be confirmed soon for delivery through the NIHR and NHS.
The huge numbers of participants recruited to UK-based vaccine studies will enable initial read-outs around vaccine efficacy in unprecedented time. Interim data published recently by The University of Oxford and AstraZeneca - from the NIHR/UKRI funded COV002 phase 2/3 vaccine trial - show that the UK-developed vaccine candidate, ChAdOx1 nCoV-2019, is effective at preventing Covid-19 and offers a high level of protection.
The four NIHR-supported vaccine trials currently underway across the UK are:
- Novavax Covid Vaccine Study: 15,203 participants
A phase 3 trial of NVX-CoV2373 - a recombinant spike protein nanoparticle vaccine developed by US biotech firm, Novavax. The world’s first participants to receive the vaccine through this phase 3 trial were recruited in the UK through one the NIHR’s new Patient Recruitment Centres
- Oxford Vaccine Trial (COV002): 10,780 participants
A phase 3 trial of ChAdOx1 - an adenovirus vaccine vector. Jointly funded by NIHR and UKRI, COV002 was one of the world’s first Covid-19 vaccines to move into phase 3 trials with fast-tracked research delivery support provided by NIHR
- Janssen Phase 3 Vaccine Study: 641 participants (study opened for recruitment mid-November)
The world’s first phase 3 trial to test the safety and effectiveness of a vaccine developed by The Janssen Pharmaceutical Companies. The study will recruit 30,000 people worldwide.
- Imperial Vaccine Trial: 414 participants
Jointly funded by NIHR and UKRI, this is an early stage (phase 2) trial of LNP-nCoVsaRNA - a self-amplifying RNA vaccine developed by Imperial College London
Monitoring infections and transmission
Advancing the science around how the virus spreads across the population is vital to tackling the pandemic. The NIHR is supporting many important studies within this area, the findings of which are shared with public health authorities and SAGE in real-time.
These include the ONS Covid-19 Infection Survey, a surveillance study which has now enrolled 321,200 participants. This observational study is investigating the incidence of Covid-19 infection and prevalence of immunity to Covid-19 in the UK general population - assessed through repeated cross-sectional household surveys with additional serial sampling and longitudinal follow-up.
The ONS data looks at Covid-19 infections in the community, and does not include cases in hospitals, care homes or other institutional settings. The data established through this study provides important metrics on where infection rates are rising across the country - and is used to inform scientists and the Department of Health and Social Care in their ongoing response to the coronavirus pandemic.
Ensuring that rapid, accurate and effective testing is widely available across the population is a key element in controlling the spread of the disease. Accurate diagnosis of infection, identification of immunity and monitoring the clinical progression of infection is of paramount importance. NIHR is supporting key research within this area through the Covid-19 National DiagnOstic Research and Evaluation Platform (CONDOR). A range of diagnostic/observational studies are currently ongoing through this platform which will lead to the development of advanced new diagnostic testing technologies.
Research into other conditions
Alongside the Covid-19 research, the NIHR continues to support a wide and active portfolio of research into other conditions. 2,715 non-Covid studies have recruited participants since March 2020 and a further 1,000 studies are currently being set up. Over 210,000 participants have been recruited into these studies since March 2020. However, with many NHS services disrupted by Covid-19 and on occasion, staff diverted to frontline care, the pandemic has had a very serious impact on non-Covid research. NIHR is working with the life sciences industry and the health research charities and the NHS to support research continuing and enhancing into non-Covid areas wherever possible.
Study participants and research data
It is important to note that patients can take part in more than one study - for example in observational and interventional trials simultaneously - therefore the total number of participants does not equate to the same number of individual patients involved in studies. To ensure patient confidentiality, the NIHR does not keep data on individual numbers of patients.