Researchers at the University of Oxford are starting a new study to explore the effectiveness of a common arthritis drug, adalimumab, as a treatment for patients with COVID-19 in the community, especially care homes.
Recent studies of patients with COVID-19 have shown that patients already taking anti-tumour necrosis factor drugs for inflammatory arthritis and inflammatory bowel disease are less likely to be admitted to hospital than expected. The same was not observed for patients taking other anti-inflammatory drugs.
The AVID-CC trial, which will be conducted by Oxford Clinical Trials Research Unit (OCTRU), will enrol up to 750 patients from community care settings throughout the UK.
It is funded by the COVID-19 Therapeutics Accelerator, an initiative launched 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 some 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.
Recent evidence has shown that care home residents already taking anti-TNF drugs for inflammatory conditions are less likely to be hospitalised with COVID-19.
“This 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, at the University of Oxford, and the NIHR Oxford Biomedical Research Centre’s (BRC) Musculoskeletal Co-theme Lead.
“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, RECOVERY, which is taking place in hospitals, and PRINCIPLE, in primary care.
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.”
Oxford Hospital at Home Service receives support from the Oxford BRC.
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.”