A trial to find out if kidney patients can benefit from additional protection from Covid-19, using a drug routinely used to treat tapeworm, has opened at Leicester's Hospitals.
The trial is investigating 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.
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 treatment will last up to nine months.
Led by scientists from the Cambridge University Hospitals NHS Trust and the University of Cambridge, the trial began in Addenbrooke’s Hospital, Cambridge, earlier this year and is now being expanded across the country.
Professor Jeremy Hughes, 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, data collected before the vaccine rollout began showed 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.
"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.
“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."
Professor James Burton, Honorary Consultant Nephrologist at the University Hospitals of Leicester NHS Trust, said: “We are delighted to be part of this important trial. It is vital we find a way to protect 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.
“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, indeed there are early indications that not all transplant patients respond to two doses of some Covid vaccines. While the vaccine may 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 is recruiting at least 1,500 kidney patients across the UK, who are being 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 trial news comes as the coronavirus vaccine rollout continues, but amid concerns over new virus variants. Data regarding the effectiveness and durability of vaccine response in kidney patients will be published shortly. 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 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.
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