Kidney patients are at serious risk from Covid-19. One in five kidney patients receiving dialysis in hospital or who have a kidney transplant, who tested positive for the virus, died within four weeks.1
People on dialysis, who’ve had a kidney transplant or have an auto-immune condition affecting the kidneys can take part in the trial, beginning in Cambridge with a plan to roll out across the UK.
Kidney Research UK is working with other partners to protect kidney patients who are usually excluded from Covid-19 trials.
If the charity and industry funded trial is successful, it may pave the way for a new treatment to prevent or alleviate the impact of Covid-19 in people on dialysis, people who have had a kidney transplant, and people with auto-immune diseases affecting the kidneys such as vasculitis, who require treatment to suppress their immune system. The trial will last up to nine months.
Led by scientists from the Cambridge University Hospitals NHS Trust and the University of Cambridge, the trial will start in Cambridge with a plan to expand to other UK healthcare centres.
Kidney patients recruited will be randomised to receive either a placebo (or dummy) drug, or UNI91103 (niclosamide as a nasal spray), both provided by the manufacturer UNION therapeutics, in addition to all their usual treatments.
The news comes as the coronavirus vaccine is being rolled out across the country but amid concerns over virus mutations and limited data regarding the effectiveness and durability of vaccine response in kidney patients. Participants can receive the vaccine and still take part in this trial, which will identify whether niclosamide can protect people from the virus either on its own, or in combination with any of the vaccines currently available.
The drug, niclosamide, has been re-formulated into a nasal spray so it can be delivered directly to the lining of the nasal cavity, like a hayfever spray. In the trial, people will take one puff up each nostril twice a day, as this is the part of the body where the virus can take hold. This ‘local’ drug delivery is likely to reduce the chances of people experiencing any side effects.
Usually used to treat intestinal worms and taken as a tablet, niclosamide has shown real promise in the lab. Early tests revealed niclosamide could stop SARS-CoV-2 multiplying and entering cells of the upper airways.
Professor Jeremy Hughes, kidney doctor and chair of trustees at Kidney Research UK, one of the charities funding the trial (pictured), said: “We must do everything we can to protect kidney patients, who are at serious risk from Covid-19. Sadly, one in five kidney patients receiving dialysis in hospital or who have a kidney transplant and tested positive for the virus died within four weeks.
“Many of those on dialysis are having to put themselves at risk and attend their renal unit for life-saving dialysis treatment several times each week. And those who have had a kidney transplant must continue taking their immunosuppressant drugs, despite these making them more susceptible to infection. In the UK alone, round 64,000 people receive dialysis treatment or have had a kidney transplant2 – that’s enough people to fill the O2 stadium three times over.”
He continues: “The vaccine roll-out can’t come fast enough - kidney patients should have the vaccine, as soon as they are offered it. We hope this trial will add an extra layer of protection for kidney patients in the future. It could even reveal a way to prevent Covid-19 in other vulnerable people.”
He explains: “This trial shows why funding research into kidney disease is so important right now. Committing funds to this trial was a challenge for Kidney Research UK. Like so many other charities, our income this year has been badly impacted, and has dropped by 50% but the PROTECT-V trial, and the patients it aims to help, could not wait. We are delighted to be partnering with others to make this crucial research a reality. Kidney patients need our work to continue, now more than ever.”
Vulnerable kidney patients are more likely to fall seriously ill or die from the virus than those without any health complications, as Ben Baylis, secretary and player at Wisbech Town Walking Football Club is well aware. His father died of kidney disease when Ben was nine. Ben is two-years post-transplant and only feels safe because he lives in a rural location.
“Covid is not going away any time soon and if it gives protection and much needed peace of mind then this research will be vital for people,” he said.
“I’m aware I am lucky. I am retired, living in a house with a lovely big garden in a remote location, so in lockdown I could garden, walk the dogs, run around the garden to keep fit. I don’t have the financial pressures of a younger man with small children, concerned not just for health but also finances. I am also aware that if I was a high-shielder living in a city, I would not have been so relaxed.”
Dr Rona Smith, senior research associate at the University of Cambridge and honorary consultant nephrologist at Addenbrooke’s Hospital, who is leading the UK study, said: “It is vital that we find a way to protect patients on haemodialysis and other high-risk kidney patients from catching SARS-CoV-2 and developing Covid-19. If they get it, they are more likely to fall seriously ill or die, and we need to find a way to change that.”
She continues: “A number of existing trials are searching for an effective Covid-19 preventative treatment, but patients with impaired kidney function are largely excluded, despite being so vulnerable to the disease. Patients should have the vaccine wherever possible, which will give them a level of protection against the virus.”
She explains: “But we believe testing niclosamide is particularly important for people who are immunosuppressed and have kidney disease, because their immune responses to vaccines can sometimes be less effective. While the vaccine will offer a level of protection, niclosamide may provide further protection against Covid-19 that doesn’t rely on the immune system mounting a response.”
She adds: “If successful, our innovative trial could mean that the treatment becomes available to kidney patients more widely within months. It would mean they could receive their regular life-saving dialysis or take their immunosuppressant drugs without additional worry. And if it’s successful it could even be rolled out more widely – and benefit more vulnerable people.”
The trial, led by the Cambridge University Hospitals NHS Trust and the University of Cambridge, involves researchers and patients from across the UK. It is funded by LifeArc, Kidney Research UK, the Addenbrooke’s Charitable Trust and UNION therapeutics and is supported by the NIHR Cambridge Biomedical Research Centre. UNION therapeutics is supplying the drug.
LifeArc has made £10 million available to develop new therapeutics to support the global effort against Covid-19. “Repurposing already available drugs or those in the late stage of development offers the fastest route to bring benefit to patients at this critical time,” said LifeArc CEO, Melanie Lee.
Kidney patients who would like to take part in the PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion (PROTECT-V) trial should speak to their nephrologist in their local centre to find out if they are participating in the trial and if they are eligible to take part.
References
1) Source: UK Renal Registry, data from March-November 2020
2) Source: UK Renal Registry