UK recruits first global patient to antibody treatment study to protect against COVID-19
The world’s first participant in a new antibody treatment study to protect against COVID-19 has been recruited at the University College London Hospitals (UCLH) NHS Foundation Trust.
The trial is for people thought to have come into contact with a confirmed COVID-19 case. The AstraZeneca study called STORM CHASER, began recruiting participants at UCLH’s new Vaccine Research Centre, and is being delivered by the NIHR.
Through the use of a monoclonal antibody, the study hopes to offer immediate protection to people who have recently been exposed to the virus and prevent them developing infection.
Antibodies are protein molecules that the body produces to help fight infections. Monoclonal antibodies are artificially produced in a laboratory and designed as possible medical treatments. Monoclonal antibodies are designed to be injected directly into the body, unlike vaccines which encourage the immune system itself to produce antibodies.
The study is one of two national priority trials focused on the treatment of two investigational antibodies, known as AZD7442. The PROVENT trial, another AstraZeneca study, is looking at the use of the long-acting antibody combination in people who may not respond to vaccination, for example someone who has a compromised immune system or are at increased risk of COVID-19 infection.
The antibodies have been engineered with AstraZeneca’s proprietary half-life extension technology to increase the durability of the therapy for six to 12 months following a single administration. The combination of two antibodies is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus.
In both studies, researchers are assessing whether the treatment reduces the risk of developing COVID-19 and/or reduces the severity of infection compared to placebo.
Key participant groups in the STORM CHASER study include healthcare workers, students living in group accommodation, and patients exposed to anyone with the SARS-CoV-2 virus which causes COVID-19, as well as residents of long-term care facilities and industrial/military settings.
Both trials are taking place at UCLH’s Vaccine Research Centre, which opened in December 2020, under the patronage of the NIHR UCLH Biomedical Research Centre, to help accelerate the development of new vaccines and treatments during the COVID-19 pandemic. The centre represents an extension of the existing NIHR UCLH Clinical Research Facility (CRF).
Prof Andrew Ustianowski, Joint National Specialty Lead for Infection, National Institute of Health Research (NIHR), and Chief Investigator of the study said:
"We have had very encouraging data on COVID-19 vaccines and these are imminently being rolled-out to our populations. We have some significant improvement in our management of those with COVID-19. What we don't yet have, but need, are interventions in the post-exposure setting. STORM CHASER is exploring the use of a combination of monoclonal antibodies given intramuscularly in those who have been exposed to SARS-CoV2 - a setting where vaccination would not have time to work and we have no other proven therapies to date. Therefore this is an important study that may have a large impact on our ability to control this infection.
"Today's announcement shows once again the UK's ability to set up world-leading research into COVID-19. It is a credit not only to the research team involved, but the thousands of people at the NIHR and the NHS who have delivered COVID-19 vaccine research in ground-breaking time."
Mene Pangalos, AstraZeneca Executive Vice President, BioPharmaceuticals Research & Development, said:
“AZD7442 has the potential to be an important preventative and therapeutic medicine against Covid-19, focusing on the most vulnerable patients. This work complements our vaccine development programme.
“The STORM CHASER trial in particular is a unique approach, with enrolment initiated on site following the identification of a confirmed case to halt the spread of Covid-19 in the facility or community. We offer our appreciation and gratitude to everyone involved in these trials, from the scientists, researchers and clinicians, to the trial participants and study sites, as we all work together to help end this pandemic.”
Professor Bryan Williams, Director of Research, University College London Hospitals NHS Foundation Trust, said:
“This is a great example of the NHS at its best. As well as delivering care for patients, UCLH is also undertaking the type of world-leading and ground-breaking research we champion as a research hospital and NIHR Biomedical Research Centre.”