UK researchers are launching a clinical trial to investigate if the drug niclosamide, usually used to treat tapeworms, can prevent COVID-19 infection in vulnerable, high-risk kidney patients and reduce the number of people who become seriously ill or die from it.
If the charity and industry-funded trial are 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 treatment 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. It will recruit at least 1,500 kidney patients, who will be randomised to receive either a placebo (or dummy) drug or UNI911 (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.
Niclosamide has been reformulated 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, a kidney doctor and chair of trustees at Kidney Research UK, one of the charities funding the trial, 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 have 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, around 64,000 people receive dialysis treatment or have had a kidney transplant – that’s enough people to fill the O2 stadium three times over.
“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.
“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.”
Dr Rona Smith, a 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.
“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.
“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.
“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 repurpose new therapeutics to support the global effort against COVID-19.
LifeArc CEO Melanie Lee said:
“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.”