Cardiff University: Clinical trial investigates protection from Covid-19 within hours
A potential new therapy which may provide almost immediate protection against Covid-19 for immunocompromised people, is being tested in clinical trials.
The RAPID-PROTECTION study focuses on Evusheld, a combination of two antibodies that prevent the Covid-19 virus from infecting human cells.
People with weakened immune systems – such as patients with cancer, inflammatory conditions and organ transplants – remain at high risk of catching Covid-19, despite vaccinations and booster vaccinations. Patients with these conditions still need to undertake significant precautions, including shielding, to protect their health from the ongoing pandemic.
Evusheld has been shown in clinical trials to prevent Covid-19 infection for up to a year after a single dose of two injections, giving protection within a few hours.
Unlike vaccines, it does not depend on a healthy immune system to generate protective immunity. Although Evusheld is known to be effective against the Omicron variant, it is not yet known how long this protection lasts.
The study will be coordinated by the Centre for Trials Research at Cardiff University, in collaboration with Oxford University Hospitals NHS Foundation Trust and University of Oxford.
“Our team at the Centre for Trials Research are delighted to be working in partnership with colleagues in Oxford on this important treatment trial for the prevention of serious Covid-19 infection in immunocompromised patients,” said Dr Emma Thomas-Jones, Deputy Director of Infections, Inflammation and Immunity Trials at the University’s Centre for Trials Research.
“These patients have been shielding for over two years, and hopefully this treatment, in conjunction with the Covid-19 vaccine roll-out, will be beneficial for them. It is vital that research like this is conducted to help find new ways to protect these patients from Covid-19.”
The Medicines and Healthcare products Regulatory Agency approved the use of Evusheld in March 2022, meeting the UK regulatory standards of safety, quality and effectiveness.
Approximately 350 participants will be recruited across the UK for the study, receiving an injection of Evusheld, followed by a Covid-19 booster vaccination four weeks later. Regular blood tests over the course of a year will assess the patients’ immune protection.
Dr Mark Tuthill, Chief Investigator of the RAPID-PROTECTION study and Consultant Medical Oncologist at Oxford University Hospitals NHS Foundation Trust, said: “The RAPID-PROTECTION study will offer patients that remain vulnerable to Covid-19 despite vaccination Evusheld, a medicine that prevents Covid-19 in healthy unvaccinated people. We will test the level of immune protection that the treatment offers to vulnerable patients, and whether this protection can be improved by a repeat Covid-19 vaccination.”
The trial is open to recruitment at Oxford University Hospitals NHS Foundation Trust, The Royal Marsden Hospital, and Northampton General Hospital. The team is also aiming to open recruitment at Clatterbridge Cancer Centre and University Hospital of Wales to recruitment in Dec 2022/Jan 2023.
Volunteers must be 18 years or over and have an impaired immune system.
Participants must be willing to attend hospital for a total of seven visits throughout the study. Reasonable travel expenses will be reimbursed. This clinical trial would not be suitable for anyone pregnant or intending to become pregnant in the next year.