As the global COVID-19 pandemic has progressed, evidence has emerged that some patients who survive the virus are experiencing prolonged symptoms and complications beyond the initial period of acute infection and illness.
Termed Long COVID, it can present with clusters of symptoms that are often overlapping and fluctuating. Symptoms include breathlessness, headaches, cough, fatigue and cognitive impairment or ‘brain fog’, while there is also emerging evidence that some people experience organ damage.
As the scope of testing widens, the number of patients reporting Long COVID symptoms is also increasing. In a survey by the UK Government's Office for National Statistics last November, one in ten people had symptoms that lasted for 12 weeks or longer.
The implications and consequences of such ongoing clinical manifestations are a growing health concern.
While large ongoing studies in this field include PHOSP-COVID, an 18-month study that is assessing the long-term health outcomes for 10,000 people who have been admitted to hospital with COVID-19, the Government has recognised a need for research for those experiencing longer-term symptoms but who do not require hospital admittance.
Following a UK-wide call to find ambitious and comprehensive research programmes to help address this issue, the Government has awarded the University of Birmingham £2.3 million over two years to lead a major clinical digital study, called the TLC Study (Therapies for long COVID in non-hospitalised individuals: from symptoms, patient-reported outcomes and immunology to targeted therapies).
Announcing the funding, Health and Social Care Secretary, Matt Hancock, said: “We need to better understand Long COVID and identify therapeutics that can help recovery. This funding will kick-start ambitious projects to do just that.”
Funded through the National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI), the TLC Study aims to identify which treatments are most likely to benefit people with particular symptoms of Long COVID and test supportive treatments to improve their quality of life.
Principal Investigator Dr Shamil Haroon, Clinical Lecturer in Primary Care at the University of Birmingham, says: “People living with Long COVID have indicated that they feel abandoned and dismissed by healthcare providers, and receive limited or conflicting advice.
“Meanwhile, neither the biological or immunological mechanisms of Long COVID, nor the rationale for why certain people are more susceptible to these effects, are yet clear, limiting development of therapies. It’s essential we act quickly to address these issues.”
Using electronic GP records in partnership with the Clinical Practice Research Datalink (CPRD), the team will identify and recruit thousands of non-hospitalised patients with Long COVID who have had symptoms for 12 weeks or longer to the study, at the heart of which will be the use of a digital platform, called Atom5™ from med-tech company Aparito Limited. Through the app, patients will self-report symptoms, quality of life and work capability.
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A sub group of patients will receive blood and other biological tests to understand the immunology of Long COVID, and will wear a device that will measure their heart rate, oxygen saturation, step count and sleep quality.
Using their findings, the researchers will co-produce with patients a targeted intervention for Long COVID, tailored to individual patient need. Delivered remotely in the community, via the Atom5™ app, it will provide critical support and information to empower patients in self-managing Long COVID. Tailored resources to support symptom management and nurse-led support for those with the severest symptoms will also be provided.
The researchers will also use the digital platform to assess whether the treatments and supportive interventions reduce symptoms, improve quality of life, and are good value for money.
All data gathered will be used to help the scientists characterise the symptoms, health impacts, and underlying causes of Long COVID syndromes in non-hospitalised patients – providing invaluable insight not currently available.
Co-Principal Investigator Melanie Calvert, Professor of Outcomes Methodology and NIHR Senior Investigator at the University of Birmingham, adds: “Our study aims to reduce symptom burden and improve quality of life. Ultimately, people want to be able to enjoy life again and spend time with their friends and family.
“It is clear that there is an urgent need for research to help explain the causes that drive the longer-term health effects of COVID-19 so that we can optimise patient care.
“Our digital trial platform in primary care will not only facilitate research exploring the underlying cause of Long COVID, but also the evaluation and co-production of suitable interventions.”
The TLC Study has been warmly welcomed, with Chief Medical Officer for England and Head of the NIHR, Professor Chris Whitty, saying: “Good research is absolutely pivotal in understanding, diagnosing and then treating any illness, to ease symptoms and ultimately improve lives.
“This research will increase our knowledge of how and why the virus causes some people to suffer long term effects following a COVID-19 infection - and will be an important tool in developing more effective treatments for patients.”
Meanwhile, Health Minister, Lord Bethell, adds: “The UK is at the forefront of scientific research and innovation when it comes to the treatment of COVID-19.
“This research will make the best use of available evidence to help us identify the causes, the consequences and most importantly the best treatments to help people recover from COVID-19 in the long term.”
The TLC study will include a Lived Experience Advisory Panel (LEAP), made up of a group of Long COVID patients, who will work with researchers and clinicians to develop the research from a patient perspective.
LEAP member and long COVID patient Dave Stanton, aged 74, says: “COVID-19 has knocked me sideways, with a long and debilitating battle since initially becoming ill in March last year, including having to have surgery to replace my pacemaker following additional damage the virus has caused to my heart.
“Each day is baby steps in terms of recovery, but almost one year on I am still battling a myriad of symptoms from memory loss to difficulties breathing, pins and needles, and immobility.
“I am delighted to be part of this research project, which will give hope to so many out there who are, like me, struggling with the longer term crippling effects of this virus.”
The research team consists of multi-disciplinary experts heavily involved in COVID-19 research from across the University of Birmingham, as well as the Medicines and Healthcare products Regulatory Agency. Project partners will include patient campaign group LongCovidSOS, the National Institute for Health and Care Excellence (NICE), the UK Coronavirus Immunology Consortium (UK-CIC) led by University of Birmingham Professor Paul Moss, and PHOSP-COVID.
Dr Shamil Haroon
Academic Clinical Lecturer
Shamil is a public health researcher and general practice trainee with a special interest in chronic obstructive pulmonary disease and preventative medicine.
Professor Melanie Calvert
Professor of Outcomes Methodology
Melanie is Director of the Centre for Patient Reported Outcomes which aims to optimize the use of PROs in clinical trials and routine care.
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