First Addenbrooke’s Patient in National COVID-19 Trial
The Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial, will test several medications that are safely used for other conditions, and that have shown promise in other countries.
The opportunity to join this trial will be offered to adults who are hospitalised with COVID-19 at Addenbrooke’s, and other participating NHS hospitals across the country, and who do not have health conditions that would interact with the trial drugs. There are 3 drugs being tested in the first stages of the trial, including hydroxychloroquine, which is similar to a drug used to treat malaria and some rheumatic diseases. However, the trial follows an ‘adaptive’ design, which means that if further drugs show promise, they can be added to the treatments being tested.
The trial results will be regularly reviewed so that any treatments that are found to be effective can be made available to all patients.
Participation in this national trial is part of Cambridge’s wider contribution to COVID-19 research. Local principal investigator Dr Martin Knolle said “this is an example of Cambridge researchers, as part of a national effort, pulling together to deliver potentially life-saving treatments in record time in the most difficult of circumstances. I am very proud of our team and research community for this response.”
Update on clinical research during the COVID-19 outbreak
We are reviewing all of our clinical research with Cambridge University Hospitals (CUH) and the University of Cambridge. Each study is being assessed on a case-by-case basis to minimise risks to participants either from continued participation in or disruption to a trial that forms part of their clinical care.
Some studies will need to pause or wind down to release staff for clinical roles and sample processing infrastructure to support the NHS.
Chief and Principal investigators should review their studies and assess the risk to participants posed by COVID-19. Following risk assessment, please confirm your proposed mitigations or actions with Professor John Bradley, Director of Research, as soon as possible.
Research participants will be contacted by their study team with updates about any changes to the study they are enrolled in. Please contact your study team if you have any further questions about your study or your participation during these events. Participants who believe they have COVID-19 symptoms should follow Department of Health and Social Care advice and contact their study team.
Patient and Public Involvement (PPI):
CUH is committed to supporting the research effort against COVID-19, and patients and the public will have a particularly valuable role as we embark on this. The PPI team are working remotely, but are still available to speak to researchers who need assistance with PPI for their grant applications or documentation reviewed by the CUH PPI panel. Our panel has over 70 people who are willing to review research-related documents and this service is still available, with our panel members very committed to continuing their support for researchers during this period.
Non-essential visits to the campus are not permitted at this time. As such, we have cancelled all in-person meetings and training that were planned through to the summer. This will continue to be reviewed as the situation changes. All filming and work experience in our research buildings have been suspended/ cancelled due to the current restrictions in place.
The PPI and communications team are also investigating options to run their training sessions and other PPI activities online.
If you need any assistance contact the PPI team: firstname.lastname@example.org
COVID-19 research studies at CUH
Chief and Principal Investigators of studies have been reviewing whether part or all of their studies need to be put on hold. Many existing studies are now suspended, and the NIHR Clinical Research Network is pausing any studies that are not nationally prioritised COVID-19 studies.
The NIHR has emphasised the need to prioritise COVID-related work, and are putting in place mechanisms for fast-tracking nationally prioritised studies through HRA and MHRA. A COVID-19 and Clinical Research Oversight Group has been established under the governance of the NIHR Cambridge BRC and will review nationally prioritised studies to consider which can be supported locally with the available resources.
The group will also consider proposals for studies to be sponsored by Cambridge University Hospitals and / or the University of Cambridge, but these are likely to need to have national reach or build on unique local capability to meet the threshold for fast -tracking through HRA / MHRA approval processes.
Professor Ian Wilkinson, Director of the Cambridge Clinical Trials Unit (CCTU), is also establishing a committee to review proposals for clinical trials related to COVID-19.
If you have questions, research proposals or clinical trials that you wish to be considered please contact Covid19research@addenbrookes.nhs.uk in the first instance.
New National guidance for prioritising funding and support for COVID-19 research across the UK
Given the extraordinary pressures currently being faced by the health and care system, we must also ensure that we are making best use of the limited resources and capacity available to support research.
We will do this by establishing and implementing a single, national process that will allow the Chief Medical Officer (CMO) / Deputy Chief Medical Officer (DCMO) for England to draw on expert advice to prioritise the COVID-19 studies which hold the most potential for tackling the challenges we face.
This process will cover all funded studies, irrespective of whether they are funded by the public sector, industry or charities and also, in partnership with UKRI, studies that require funding. It aims to prevent duplication of effort and to ensure that the capacity of the health and care system to support research is not exceeded.
Details of the process and the new single point of entry for prioritising COVID-19 studies an be found here.
With regard to HRA approvals, researchers should make an application through the national prioritisation process first and will be signposted for expedited regulatory approvals so that approval review can progress in parallel to the system of assessment leading to a view from CMO/DCMO on prioritisation.
All NHS Trusts, health and care providers and universities will need to prioritise support for studies which have been nationally prioritised. A live list of these studies is being collated. Organisations may support COVID-19 research activity only when this does not impact on the system’s ability to recruit participants and/or provide the resources (including staff, samples and data) needed to support nationally prioritised research. Organisations will be expected to pause any local studies that impede their ability to contribute to national research efforts.
- Government support for research related to COVID-19: Find out how to get your study nationally supported or funded as high priority COVID-19 Urgent Public Health Research.
- COVID-19 and Clinical Research Oversight Group CUH: This has been established under the governance of the NIHR Cambridge BRC and will review nationally prioritised studies to consider which can be supported locally with the available resources.
- NIHR response to COVID-19 pandemic: All NIHR updates on one page.
- Covid-19 response from the NIHR Cambridge BRC: Information for researchers, academics and clinicians on clinical research taking place on the Cambridge Biomedical Campus during the COVID-19 outbreak.