- Decentralised model to allow remote participation in trial among patients
- Trial design adapted to further investigate potential link between COVID-19 and hypertension
London, UK, 18 November 2020: Closed Loop Medicine (‘CLM’) a clinical stage therapeutics company developing drug + digital combination products, announces that the first patient has been recruited into its pivotal clinical trial investigating CLM’s integrated precision care solution for patients with hypertension.
The clinical trial, called Personal COVID BP, will see up to 1,000 patients recruited for a study investigating whether a combination product that links a drug to a smart phone app can enable patients to personalize and optimise their therapy regimen to treat hypertension. Importantly, the technology in the study allows patients shielding from COVID-19 to control their blood pressure remotely in a home setting environment.
The interventional arm of the study, in which up to 200 patients are involved, will see patients receive drug therapy while using an app to monitor blood pressure, as well as any potential side effects. This will help to determine whether the approach can be used to identify the optimum balance of tolerable side effects and controlled blood pressure. The ultimate aim of the study is the development of a novel combination product that will have the potential to save thousands of lives through fewer heart attacks and strokes.
As part of the study, CLM’s technology will also be used to monitor COVID-19 symptoms to allow for a better understanding of the links between COVID-19 and high blood pressure. A Nature publication[i] published in May 2020 analysed 17 million medical records to show a complex link between COVID-19 mortality and patients with high blood pressure.
The trial is part-funded by Innovate UK and is being run by the William Harvey Clinical Research Centre (WHCRC), Queen Mary University of London, part of the National Institute for Health Research (NIHR) Biomedical Research Centre at Barts (BRC).
Dr Hakim Yadi OBE, CEO & Co-Founder of CLM commented: “This represents a key milestone for the company, the first patient enrolled and dosed in our interventional clinical study. Our aim is to improve patient outcomes while supporting health systems to better manage patients with long-term conditions through remote monitoring and timely intervention. The trial design allows greater patient participation from the comfort and safety of their own home whilst also investigating the potential link between COVID-19 and hypertension. We look forward to progressing this important trial alongside our partners at Queen Mary University, and to reporting further progress over the coming months.”
Dr David Collier, the lead trial investigator from Queen Mary University of London commented: “This is an important study in that it allows patients and physicians to collect real-world data to help better inform treatment decisions and monitor patient outcomes. Some of the drugs we use are great at preventing heart attacks and strokes, but frequently cause unwanted side-effects, something this trial sets out to address. We hope that through this study we can not only demonstrate that one size does not fit all, but that by using technology in this combined way, we can personalise treatment for the individual at a population scale.”