It is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome, the Bill and Melinda Gates Foundation and Mastercard, with support from an array of public and philanthropic donors.
Residents of care homes were particularly hard hit by the first wave of COVID-19 in the UK and other countries. Research has identified limited treatments that are effective for patients in hospital with COVID-19, but no effective treatments have yet been identified for those in the community care settings, many of whom may have severe symptoms.
Anti-tumour necrosis factor (anti-TNF) drugs have been in widespread use for over 20 years for a range of inflammatory conditions. Recent studies of patients with COVID-19 have shown that patients already taking anti-TNF drugs for inflammatory bowel disease and inflammatory arthritis are less likely to be admitted to hospital. The same was not observed for patients taking other anti-inflammatory drugs. The availability of biosimilar versions of biological treatments has been an important step forward in driving down costs, making the anti-TNF treatment affordable and accessible if the trial is successful.
"The observed potential of anti-TNF drugs has prompted us to conduct a study in patients in community care to see whether treatment with the anti-TNF drug adalimumab reduces the progression to severe or critical disease or death in COVID-19 patients," said Prof Duncan Richards, Professor of Clinical Therapeutics, University of Oxford. "We think anti-TNF drugs could be an important treatment for COVID-19 and are very grateful for the support of the COVID-19 Therapeutics Accelerator, which will allow us to find out. I would also like to thank Sandoz Ltd for provision of adalimumab. We are also looking forward to working with Sensyne Health to collect additional information on patients' clinical status through their app. Subject to the necessary approvals we hope to start recruiting patients in late October."
The study will be delivered by Hospital at Home teams around the UK. Hospital at Home is a relatively new service in which hospital-based teams reach out into the community to deliver more complex treatment interventions while avoiding the need for admission to hospital. This study sits therefore in a unique niche between the existing national platform therapeutic studies PRINCIPLE (primary care) and RECOVERY (hospitals).
Prof Dan Lasserson, Professor of Acute Ambulatory Care, University of Warwick who also works as a clinician in a Hospital at Home service for Oxford University Hospitals NHS Foundation Trust, said: "This is the first drug trial designed for Acute Hospital at Home services and it could not come at a more important time. We need to determine the best treatments for COVID-19 that can be given to older people with frailty who are in care homes or living in their own homes. This grant from the COVID-19 Therapeutics Accelerator not only helps us determine whether anti-TNF drugs could improve outcomes, but the trial itself will help the development nationally of acute hospital at home services."
Professor Adam Gordon, Professor of Care of Older People at the University of Nottingham, and Consultant Geriatrician, said, "We have seen lots of examples, earlier in the COVID pandemic, of older people in care homes being disadvantaged regarding access to treatments simply because of where they live. This study is an exciting opportunity to open up promising treatments to this most vulnerable, and underserved, group of people. It is an important step forward as we investigate how to manage COVID, and more generally in terms of bringing research to the frailest older people."
Oxford Hospital at Home Service receives support from the Oxford NIHR Biomedical Research Centre.