New clinical trial aims to improve diagnosis, treatment and rehabilitation of long COVID
A major new consortium involving the University of Exeter, 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 University College London Hospitals NHS Foundation Trust (UCLH) and University College London, 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 that the programme will deliver knowledge to clinicians and scientists, evidence to policymakers, and improved care to patients, while collecting real-world data at scale.
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.
Each of the treatments in the trial is a commonly-used medication for another purpose, meaning it already has an approved safety profile and could swiftly become standardised care if found to be effective. At the same time, the work will evaluate the optimum level of support that is benefits people, and what are the social determinants of outcomes.
The treatments are drawn from previous research by Dr David Strain of the University of Exeter, in collaboration with advocacy groups such as longCovidSOS, which surveyed 928 people with long covid to ascertain what treatments they had tried to alleviate their symptoms, and the impact of the vaccine.
Dr Strain, of the University of Exeter, is one of the trial leads. He said: “Long covid is incredibly distressing and debilitating, and we still know relatively little about how to treat and support people who experience it. Currently we are drawing from experience in other disease areas such as ME and Chronic fatigue syndrome, however the evidence base here is far from complete. This study will give us answers on the best treatment options, which could be swiftly rolled out in clinics.”
Repurposing existing drugs is an efficient way of finding new treatments, and one in which the UK excels. In one example, the RECOVERY Trial, led by Oxford University and embedded in the NHS, led to the discovery that arthritis treatment dexamethasone is effective in treating severe COVID-19.
And researchers will also work alongside patients to co-develop ways of improving access to care and support, to address care inequalities.
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.
The study’s co-principal investigator Professor Amitava Banerjee said: “Two million people in the UK are estimated to have had persistent symptoms for more than 12 weeks following initial COVID infection, with far-reaching impact on patients, healthcare and the economy.
“More than 80 long COVID clinics have been established around England but we need to better understand, diagnose and treat this new disease. Inequalities in access to and provision of long COVID care have already become apparent.
“Long COVID is challenging the NHS and healthcare systems around the world, which have had to deal with the acute consequences of coronavirus over the last 18 months,” said Prof Banerjee, professor of clinical data science at the UCL Institute of Health Informatics and consultant cardiologist at UCLH.
To improve recovery, the team will work out what long COVID is, how to diagnose it and how to manage it. They will interview patients and health professionals and analyse data from NHS records, informing our understanding of patterns of long COVID and the outcomes of current clinical practice.
Co-principal investigator Dr Melissa Heightman, who runs the UCLH post-Covid follow-up service, said: “We established our post-COVID clinic in London in May 2020 during the peak of the first wave, ‘building the plane while we were flying it’ and based in the hospital through necessity.
Dr Heightman, a consultant in respiratory medicine, added: “Individuals with long COVID need integrated services, working across traditional healthcare boundaries to best meet their complex care and rehabilitation needs. The aim will be to deliver timely high-quality care close to peoples’ homes with community-based diagnostics but access to specialist input when needed.”
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: “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.”
The STIMULATE-ICP trial is one of 15 new research projects across the UK awarded nearly £20 million in total by NIHR to improve diagnosis and treatment of long COVID.
Professor Nick Lemoine, Chair of NIHR’s long COVID funding committee and Medical Director of the NIHR Clinical Research Network (CRN), said:
“This package of research will provide much needed hope to people with long-term health problems after COVID-19, accelerating development of new ways to diagnose and treat long COVID, as well as how to configure healthcare services to provide the absolute best care. Together with our earlier round of funding, NIHR has invested millions into research covering the full gamut of causes, mechanisms, diagnosis, treatment and rehabilitation of long COVID.”