Supporting the kidney disease community: new results from PROTECT-V
Results from the PROTECT-V study presented at the European Renal Association in Milan on 16 June 2023 showed the study treatment, nasal niclosamide, does not offer protection against Covid-19 infection in at-risk kidney patients. Although these results are disappointing, there are many positive aspects to this study and we are delighted to have supported PROTECT-V.
Protecting kidney patients from Covid-19
Despite the success of vaccinations against Covid-19, many patients with kidney disease remain vulnerable to infection. Additional approaches, over and above vaccination, are needed to provide protection for these individuals, who are often not well-represented in clinical studies or healthcare planning.
Aisling McMahon, executive director of research and policy at Kidney Research UK added, “The rapid development of Covid-19 vaccines was a fantastic collaborative achievement across the scientific community, but not all patients benefitted equally. We recognised the need to support highly vulnerable kidney patients early in the Covid-19 pandemic and are proud to have worked with Dr Rona Smith’s team, and our other study partners, to undertake this ground-breaking clinical study.”
PROTECT-V (PROphylaxis for paTIEnts at risk of COVID-19 infecTion) is a clinical trial platform designed to assess whether different treatments can offer protection against Covid-19 infection. Supported by Kidney Research UK, LifeArc, Addenbrooke’s Charitable Trust and UNION therapeutics, alongside the NIHR Cambridge Biomedical Research Centre, the first part of the study aimed to find out whether a drug called nicolsamide, which is usually used to treat tapeworm infections but showed promise against viruses in the laboratory, could prevent Covid-19 infection in vulnerable kidney patients when given as a nasal spray.
Kidney patients aged greater than 18 years undergoing dialysis or receiving treatments that reduce their immune response (often known as ‘immunosuppressants’) were able to join the PROTECT-V niclosamide study at 36 centres across the UK and India. 1653 patients enrolled in PROTECT-V and were randomly assigned to the different treatment groups for up to 36 weeks, with both the patient and research team unaware of which group they were in. The nasal sprays were self-administered by patients twice each day. Participants were tested for Covid-19 if they had symptoms and medical data were collected by study sites and via linkage with routinely collected data sources, such as UKHSA (UK Health Security Agency (formerly Public Health England))
Results from PROTECT-V
The data from PROTECT-V showed that the nicolsamide nasal spray did not offer protection against Covid-19 infection, when compared to placebo, and patients also found that they spray was difficult to tolerate.
Dr Rona Smith commented “Clinical studies, such as PROTECT-V, are a crucial way of finding out whether positive results in early laboratory models translate into real-world benefits.
"Although we found that nasal niclosamide did not protect kidney patients from Covid-19 infection, one major benefit of the platform approach is that we can continue to investigate other options for this at-risk population using the PROTECT-V platform and I would like to thank all the patients and staff who make this important work possible.”
Learnings for the future
PROTECT-V was the largest global study to date looking at using a re-purposed agent to safeguard patients from Covid-19 infection, and has shown that with careful planning vulnerable kidney patients, with complex medical conditions, can be included in large-scale medical research.
Dr Smith commented, “By including patients who are often excluded from research, and by demonstrating the feasibility of collaboration between international hospitals of different sizes, charities and a pharmaceutical company, we hope that PROTECT-V will lead the way for many more studies in this at-risk group. We are currently investigating other medications using the PROTECT-V platform and hope for positive results next year.”
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