York joins largest clinical trial to date that aims to develop and evaluate integrated care for long COVID
19 July 2021
As part of the study, researchers will test different drugs to measure the effects of treatment on symptoms
A major new consortium involving the University of York has been awarded £6.8 million by the National Institute of Health Research (NIHR) to conduct the largest clinical study of long COVID over the next two years.
As countries around the world struggle to cope and recover from successive waves of the pandemic, the research programme will inform medium and longer-term policy and health system responses.
The consortium is led by Professor Ami Banerjee from University College London Hospitals NHS Foundation Trust (UCLH) and University College London and is made up of more than 30 researchers, health professionals, patients and industry partners from over 30 organisations working together under the banner of STIMULATE-ICP (Symptoms, Trajectory, Inequalities and Management: Understanding Long-COVID to Address and Transform Existing Integrated Care Pathways).
It is hoped the programme will deliver knowledge to clinicians and scientists, evidence to policymakers, and improved care to patients, while collecting real-world data at scale.
The team spans a wide range of relevant clinical and academic disciplines including primary care and specialist services, epidemiology, mental health and health economics. It also includes four patient groups who helped develop the research proposals.
Professor Christina van der Feltz-Cornelis, from the University of York’s Department of Health Sciences and Hull York Medical School (Hyms), is a co-investigator in the STIMULATE project and will lead on the mental health aspects of the study.
She will lead a mixed-methods study to address inequalities and transferability of the study findings, treatment and rehabilitation for people with long-term conditions.
With her team at the University of York, she will use national electronic health records, qualitative interviews and focus groups with patients, health professionals and commissioners, and develop recommendations based on findings and stakeholder engagement.
Professor Christina van der Feltz-Cornelis said: "It is exciting to be part of this massive national study developing and evaluating an integrated care model for long COVID.
"I am proud to be involved and to be able to lead on the mental health aspects, the patient experience and the transferability of the findings to other long-term conditions in collaboration with such expert colleagues all over the country.
"It is of paramount importance for the development of an integral model on a national level. This is exactly what patients with long COVID need."
Within the overall programme of research, a trial coordinated by the University of Central Lancashire will recruit over 4,500 people with long COVID, starting with six sites in Hull, Derby, Leicester, Liverpool, London (UCLH) and Exeter.
Individuals will be randomly assigned to usual care or a new pathway, including community-based, comprehensive MRI scan (using imaging technology called CoverscanTM developed by Perspectum) which can map the effects of COVID-19 on several of the body’s key organs) and enhanced rehabilitation (using a digital health platform called Living with COVID RecoveryTM developed by Living With).
Within this research programme, another trial will test different drugs, such as aspirin and colchicine, to measure effects of three months treatment on symptoms, mental health, return to work and other important outcomes.
And researchers will also work alongside patients to co-develop ways of improving access to care and support, to address care inequalities.
Denise Forshaw, Deputy Director of Lancashire Clinical Trials Unit and Principal Clinical Trials Manager from the University of Central Lancashire (UCLan), said: "Over the past year, it’s become clear that long COVID is a serious and widespread issue that is likely to last for years to come, affecting over a million people in the UK alone. While dedicated long COVID clinics are now in place, there is still much that we have yet to understand about the long-term impact and effective treatment of this illness.
"Through this research, we hope to establish effective investigation, treatment, and rehabilitation pathways that can mitigate the physical and mental health impacts of long COVID, and create a more certain future for those affected regardless of their socio-economic background."
Lyth Hishmeh, who has suffered with long COVID since the first wave of the pandemic, sees the benefit of research which considers all aspects of the patient pathway.
Lyth said: "Patients and health professionals faced and continue to face difficulties in knowing what to do for long COVID. A comprehensive study like STIMULATE-ICP is needed to look at the big picture and improve patient access to the right care at the right time in the right place."