Published: 30 June 2020
The research team at Guy’s and St Thomas’ NHS Foundation Trust, led by Dr Manu Shankar-Hari, has recruited the world’s first patient to the ILIAD-7 trial sponsored by RevImmune Inc.
Recruiting a first global patient is a key performance indicator for the global life-sciences industry in clinical research delivery as it shows that the NIHR can support the rapid set-up and recruitment of studies.
The ILIAD-7 trial has been designated as Urgent Public Health priority by Chief Medical Officer in England, and is part of global efforts to find treatments for COVID-19 disease. It is looking to recruit 48 patients in the UK and a total of 200 patients across Europe and North America.
The ILIAD -7 trial is testing whether an agent medicine called human recombinant interleukin-7 [IL-7] is able to boost the immune system’s ability to fight coronavirus infection, by increasing the numbers and function of particular white blood cells (called lymphocytes). IL-7 treatment could help to improve the patients’ clinical condition by reducing the amount of the COVID-19 virus in the body and help recovery in patients admitted to hospital with COVID-19.
The underpinning science for this clinical trial is well described. IL-7 is a protein produced naturally in the body and is a necessary infection-fighting component of the body’s immune response. IL-7 is currently also being studied in clinical trials to treat sepsis and cancer and is being used to treat patients with impaired immunity.
Dr Manu Shankar–Hari, Consultant in Intensive Care Medicine at Guy’s and St Thomas’ and NIHR Clinician Scientist, said: “I am always extremely grateful at the selfless contribution of our patients at Guy’s and St Thomas’ who agree to participate in clinical trials to help us find new treatments. At the moment we do not have a proven treatment for COVID-19, so this study along with our first patients’ altruistic contribution offers hope that this treatment could help very ill patients recover from the disease. This trial specifically identifies COVID-19 patients with impaired immunity due to low lymphocyte levels and aims to restore their immune function. Thus, it targets a subset of COVID-19 patients who have a higher risk and higher chance of treatment response.”
Michel Morre and Frederique Berbille, leading this clinical development at RevImmune Inc. added: “With IL-7 currently being used to treat other diseases in patients with impaired immunity, it is a strong potential candidate for treatment of COVID-19 disease. The recruitment of the first global patient into the ILIAD-7 trial marks a key milestone in bringing us closer to testing its efficacy for the treatment of covid-19 disease. We are grateful to the team at Guy’s and St Thomas’ for their tireless efforts which led to us passing this milestone.”
The rapid start-up and smooth running of the ILIAD-7 study has been underpinned by support provided by TCRS (www.tcr-solutions.com), a UK-based Clinical Research Organisation which delivers clinical trial services globally.