We are helping to fund PROTECT-V, a clinical trial to find out 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 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.  

Cambridge leads the way

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 in addition to all their usual treatments. The treatment will last up to nine months. 

The news comes as the coronavirus vaccine is being rolled out across the country, but amid concerns over virus mutations and limited information about how effective the vaccine response will be in kidney patients. Participants can take part in this trial even if they have had the vaccine, which will identify whether niclosamide can protect people from the virus either on its own, or in combination with any of the vaccines available.  

Showing promise in the lab

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.  

In this study, niclosamide has been re-formulated into a nasal spray so it is 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’ delivery is likely to reduce the chances of side effects. 

Protection is crucial 

“We must do everything we can to protect kidney patients, who are at serious risk from Covid-19,” explains our chair of trustees and kidney doctor Professor Jeremy Hughes. “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. Because of this, kidney patients should have the vaccine as soon as they are offered it. We hope our trial will add an extra layer of protection for kidney patients both now and in the future.” 

“Patients should have the vaccine wherever possible,” explains 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.  

“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,” she explains. “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.”  

Benefits could be seen quickly

“If successful, this innovative trial could mean that the treatment becomes available to kidney patients more widely within months,” said Jeremy. “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. We are delighted to be working with other charities to make this crucial research a reality.” 

Led by scientists from the Cambridge University Hospitals NHS Trust and the University of Cambridge, the trial 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 are supplying the drug. 

“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 Melanie Lee, CEO of LifeArc. 

Find out more

If you are a kidney patient from Cambridge or the surrounding area and would like to find out about taking part, contact your local renal unit or clinician to see if you are eligible. 

Follow us on Facebook or Twitter to see how this trial progresses. Have a look at our information page if you want to know more about the Covid-19 vaccine and kidney disease.