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October 1, 2020updated 12 Jul 2022 11:35am

Oxford team to test adalimumab against Covid-19 in care homes

Researchers at the University of Oxford in the UK have decided to initiate a new clinical trial to analyse the effectiveness of adalimumab to treat Covid-19 patients in the community care settings, primarily in care homes.

Researchers at the University of Oxford in the UK have decided to initiate a new clinical trial to analyse the effectiveness of adalimumab to treat Covid-19 patients in the community care settings, primarily in care homes.

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Adalimumab is an anti-tumour necrosis factor (anti-TNF) therapeutic. Anti-TNF drugs have been used for inflammatory conditions for more than 20 years.

Named AVID-CC, the new trial will be led by the Oxford Clinical Trials Research Unit (OCTRU) and will enrol up to 750 patients from community care homes in the country.

The study is backed by Covid-19 Therapeutics Accelerator, an initiative by Wellcome, the Bill & Melinda Gates Foundation, and Mastercard, along with some public and philanthropic donors’ support.

Care home residents were relatively hard hit by Covid-19 in the UK and other countries, owing to the unavailability of effective therapies for those in the community care settings, researchers said.

According to some studies, Covid-19 patients who were already on anti-TNF medication for inflammatory bowel disease and inflammatory arthritis were less likely to be hospitalised.

The same result was not seen in patients who were taking other anti-inflammatory drugs.

University of Oxford Clinical Therapeutics professor Duncan Richards said: “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.”

The trial will be delivered by Hospital at Home teams across the UK. The Hospital at Home service involves hospital-based teams that provide complex treatments in the community settings, avoiding the need for hospitalisation.

In July, the University of Oxford entered a partnership with Axiom Real-Time Metrics to conduct a clinical trial focused on the preventative treatments of Covid-19.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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