A drug trial that could prevent the most vulnerable people from catching COVID-19, particularly people for whom vaccines are less effective, began on 8 August in Birmingham.
The trial will test the effectiveness of Sotrovimab, a drug which has shown promising results for treating COVID-19, in people at high risk for disease progression. (Gupta et al (2021) New England Journal of Medicine, found an 85% relative risk reduction of progression of disease leading to hospitalisation or death, in patients treated with Sotrovimab.)
If proven to be safe and effective, Sotrovimab may be considered as a preventative treatment option for COVID-19 for patients who are immunocompromised, either due to their disease or the treatment they are receiving for their disease. This includes patients receiving chemotherapy for cancer treatment, immunosuppressive medications for autoimmune diseases or organ transplants, or patients with immunodeficiency.
These patient populations are at particularly high risk from COVID-19 and its complications, due to a reduced ability to be able to fight the virus, leading to severe infection and hospital admission.
These patient groups have also been shown to mount poorer responses to vaccines than healthy individuals, so identifying a drug that provides these vulnerable patients with protection is crucial. A preventative drug for the most at-risk in our populations could help to reduce hospital admissions, and potentially save many lives each year.
More than 1,700 vulnerable immunocompromised patients will be recruited to this arm of the trial, which will take place in hospitals across the UK. A single dose of Sotrovimab will be administered to patients through a drip in their arm, called an infusion.
Dr Davinder Dosanjh, co-lead of the trial and Deputy Clinical Director of Research at University Hospitals Birmingham (UHB), said: “This has been a great collaborative effort between the teams at the University of Cambridge, University of Birmingham, Cambridge University Hospitals NHS Foundation Trust, GSK, Vir and UHB.
“At UHB we have one of the largest cohorts of immunocompromised patients in the country who are not able to mount a protective immune response to vaccination, and so we have worked hard with our partners to design a trial which we believe will be of great benefit to them.
“The trial will help us to understand the immune response to COVID-19 in these individuals who mount sub-optimal vaccine responses, as well as investigating whether Sotrovimab provides a protective effect against infection.
“UHB will be one of the key recruiting sites, and it has been instrumental in getting this arm of the study up and running. We very much look forward to seeing the outcome of the study; it will be a great step forward in understanding how we can help the most vulnerable patients beat a virus that isn’t going away.”
Andrew McKniff, 56 years old, from Redditch, was one of the first participants in the trial. He said: “I’m here because I have rheumatoid arthritis and the drug that I take to manage the disease prevents me from creating any antibodies against COVID-19. I’ve had all of the vaccinations that I should have. However, I have no antibodies, which makes me very vulnerable.
"COVID-19 still has a large impact on my life and although the world has moved on to a certain extent, I can’t move on in the same way and I think there are lots of people who are in a similar position. It’s really important to have trials like this, and if the drug is found to be successful as a preventative treatment, it would mean that I would be able to go out the same as everybody else.”
Irene Bannister, another early patient in the trial, said: “I have been shielding since the beginning of the pandemic and I haven’t been able to go anywhere, apart from to the hospital. The only people who have been in my house have been family or people who have taken lateral flow tests before coming.
"COVID-19 has put a huge restriction on my life. I’m really hoping that this trial does work because in the long term, for people like me, it’s going to mean an increase in their quality of life and give them more flexibility to go out, do things they enjoy and socialise.”
Dr Rona Smith, Senior Research Associate at the University of Cambridge and Chief Investigator of the Prophylaxis for Patients at Risk of COVID-19 Infection (PROTECT-V) trial, said: “The launch of the Sotrovimab arm of PROTECT-V is a very exciting development. Not only does it add a second potential preventative drug to the platform, but also broadens inclusion beyond renal patient populations to any individual who has mounted a sub-optimal response to vaccination; fostering cross-specialty working to strengthen research.”
Launched in February 2021, PROTECT-V is a platform study designed to test the effectiveness of various drugs at preventing COVID-19 infection in vulnerable renal and immunocompromised patients. The first drug that has been tested in the PROTECT-V trial is intranasal Niclosamide, with 1,398 patients enrolled to the trial from more than 40 sites. The design of the PROTECT-V trial has meant that other promising preventative agents, such as Sotrovimab, can easily be added to the trial platform.
UHB has been a key partner in this new arm of the PROTECT-V trial, funded by GSK, and sponsored by University of Cambridge and Cambridge University Hospitals NHS Foundation Trust (CUH). It falls within the Covid-19 Understanding and Elimination-Trials Implementation Panel (CUE-TIP) portfolio, which includes research leading to the understanding and elimination of COVID-19. The core PROTECT-V trial infrastructure is supported by grant awards from Kidney Research UK, LifeArc and Addenbrooke’s Charitable Trust.
Hilary Fanning, Director of Research Development and Innovation at UHB, said: “UHB is delighted to support this trial. This is a great example of NHS hospitals working collaboratively with academic and industry partners to deliver a clinical trial, which has direct and immediate relevance to the patients we care for. As the NHS hospital that has provided care for more patients with COVID-19 than any other, we remain committed to contributing to the discovery of evidence-based treatments, to ensure we provide the best possible care for patients.”
The Sotrovimab arm of the trial began on Monday 8 August, with the first dose of Sotrovimab administered at Queen Elizabeth Hospital Birmingham. There are plans to roll out to at least 20 other centres across the UK in the coming weeks.