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April 6, 2020updated 12 Jul 2022 11:56am

Large-scale trial for coronavirus drugs launches in UK

The UK Government has announced that a large-scale randomised trial has been launched to assess potential treatments for Covid-19 (coronavirus).

The UK Government has announced that a large-scale randomised trial has been launched to assess potential treatments for Covid-19 (coronavirus).

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

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The RECOVERY trial is currently evaluating HIV drugs lopinavir/ritonavir as well as anti-inflammation steroid dexamethasone and anti-malarial hydroxychloroquine. Additional experimental drugs can be added to the study in the future.

Said to be the largest of its kind in the world, the study is being conducted by the University of Oxford at more than 130 NHS hospitals across the country.

It is designed to enrol adults hospitalised due to the Covid-19 (coronavirus) infection. So far, nearly 1,000 patients have been recruited at 132 hospitals within just 15 days and more participants are expected to register in the coming weeks.

Health and Social Care Secretary Matt Hancock said: “The UK is leading the way on research in the race to find treatments and we have now launched the largest trial in the world, pooling resources with our world-leading life science sector.

“As one of three major trials funded by the government, this marks a major milestone in our battle against coronavirus and offers renewed hope that together we can beat this.”

The UK Research and Innovation (UKRI) and the Department of Health and Social Care provided £2.1m to support the RECOVERY trial.

Safety and effectiveness data from the study is expected to be available in the coming months.

University of Oxford Nuffield Department of Medicine emerging infectious diseases and global health professor Peter Horby said: “The RECOVERY trial will provide much-needed evidence on the best care for patients with Covid-19. The more patients that are enrolled, the sooner we will know how best to treat this disease.”

Last month, researchers at the university commenced enrolment of healthy volunteers for a clinical trial of the Covid-19 vaccine candidate ChAdOx1 nCoV-19.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to implement procedures and to authorise trial applications within days of potential Covid-19 treatments.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

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
by Suvoda
Enter your details here to receive your free Case Study.

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