London, December 26: Scientists in the UK have begun trials of innovative antibody drug treatments that they hope could provide instant protection against COVID-19. The University College London Hospitals NHS Trust (UCLH) said that the researchers in the Storm Chase study believe a Long Acting AntiBody (LAAB) known as AZD7442, developed by AstraZeneca, may offer immediate and long-term protection to people who have been recently exposed to the SARS-CoV-2 coronavirus and prevent them developing COVID-19.
The study, led by UCLH virologist Dr Catherine Houlihan, recruited the first participant in the world to the study earlier this month and has recruited 10 participants since then. COVID-19 Drug Update: Favipiravir Provides Multiple Benefits in Coronavirus Treatment, Says Glenmark Pharmaceuticals.
“We know that this antibody combination can neutralise the virus, so we hope to find that giving this treatment via injection can lead to immediate protection against the development of COVID-19 in people who have been exposed – when it would be too late to offer a vaccine,” said Houlihan.
UCLH said its new vaccine research centre is running two clinical trials testing a LAAB combination treatment to protect against COVID-19. The second Provent study is looking at the use of AZD7442 in people who may not respond to vaccination, for instance where someone has a compromised immune system or are at increased risk of COVID-19 infection due to factors such as age and existing conditions.
“We will be recruiting people who are older or in long-term care, and who have conditions such as cancer and HIV which may affect the ability of their immune system to respond to a vaccine.
“We want to reassure anyone for whom a vaccine may not work that we can offer an alternative which is just as protective,” said Dr Nicky Longley, UCLH infectious diseases consultant leading the Provent study.
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. They are designed to be injected directly into the body, unlike vaccines which “train” the immune system itself to produce antibodies.
“These two clinical trials are an important addition to testing new therapeutic approaches, as antibody treatments may offer an alternative to patient groups who cannot benefit from a vaccine, such as immunocompromised patients,” said Professor Stephen Powis, the medical director of National Health Service (NHS) England.
The LAABs 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 LAABs is also designed to reduce the risk of resistance developed by the SARS-CoV-2 virus, which causes COVID-19.
“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,” said Mene Pangalos, AztraZeneca Executive Vice-President for BioPharmaceuticals Research and Development.
“Storm Chaser is exploring the use of a combination of monoclonal antibodies given intramuscularly in those who have been exposed to SARS-CoV-2 – a setting where vaccination would not have time to work and we have no other proven therapies to date. This makes Storm Chaser an important study that may have a large impact on our ability to control this infection,” noted Professor Andrew Ustianowski, who is the chief investigator of the new studies.
UCLH said that in both Provent and Storm Chaser, researchers will assess 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 trial will include healthcare workers, students who live in group accommodation, and patients who are exposed to anyone with the SARS-CoV-2 virus as well as residents of long-term care facilities and industrial/military settings.
Both trials are taking place at the newly-created Vaccine Research Centre at UCLH, which opened this month to help accelerate the development of new vaccines and treatments during the COVID-19 pandemic.
“Both Storm Chaser and Provent are crucial to finding a solution to this pandemic,” said Professor Vincenzo Libri, who leads the UCLH Clinical Research Facility backed by the UK's National Institute for Health Research (NIHR).
“The opening of our new Vaccine Research Centre will help to propel our fight against the virus, meet our aspiration to save as many lives as possible, and ensure a return to normality,” he said.
“The recent progress on vaccines is hugely welcome, and developing these additional treatments will be vital to ensure everyone in society can be offered protection against COVID-19,” Professor Marcel Levi, UCLH Chief Executive, said.