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21st September 2021

Welsh high-risk kidney patients part of new COVID study

Kidney patients across Wales, including those with kidney transplants, are taking part in a national clinical trial to investigate the effectiveness of a nasal spray to prevent COVID-19.

The PROTECT-V trial has already enrolled more than 300 clinically vulnerable patients with advanced kidney diseases across the UK. The trial will test whether niclosamide, used to treat tapeworm infection, prevents COVID-19 in vulnerable patients. The drug, which has been re-formulated into a nasal spray, will be used twice a day.

In the trial, participants will have a 1 in 2 chance of receiving the drug or placebo. They will be monitored for the development of COVID-19, and the difference between the two groups assessed.

The PROTECT-V trial is expected to last 15 months and is being led by Cambridge University Hospitals NHS Trust and the University of Cambridge. 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 treatment. It is currently open to recruitment in 24 sites across the UK, including hospitals in Betsi Cadwaladr University Health Board and Cardiff and Vale University Health Board in Wales.

Consultant Nephrologist at Cardiff and Vale University Health Board and Specialty Lead for Kidney Disorders at Health and Care Research Wales, Dr Siân Griffin, said: “Patients treated with immunosuppression, transplant recipients and those on dialysis are uniquely vulnerable to COVID-19, and may remain so, despite vaccination.

“Most dialysis patients need to attend for treatment three times a week – which makes it very difficult for them to shield. Booster vaccinations will be very important and are expected to give additional protection, but new treatments to prevent infection are urgently needed.

“Hopefully this trial will show the way forward. We’ve just started recruiting participants and will continue for the next few months. If any patients would like to take part, please speak to your Kidney Consultant.”

Dr Abdulfattah Alejmi at Betsi Cadwaladr University Health Board said: “We’re so proud to be part of this trial looking into additional treatments for dialysis and renal transplant patients, as well as those who take immune suppression medications, as they have an increased risk of becoming seriously ill from the virus.

“I look forward to see more of our patients joining this trial, as I think any possible protection against this virus outweighs the potential risk of COVID-19.”

One of the participants in the PROTECT-V trial is former nurse from Margam, Helen Williams, who had a transplant in 2012 after her husband donated his kidney as part of the pooled donation scheme.

The 55-year-old, who had been shielding since the pandemic, is extremely vulnerable as her transplant and medication has resulted in a highly suppressed immune system.

Helen talks about her involvement in the study, she said: “The pandemic has been especially hard for my family. My husband is a consultant anaesthetist who covered the ICU at Princess of Wales Hospital and he had to move out to protect me and my daughter who also suffers from the same genetic polycystic kidney disease.

“I’m delighted to be offered the opportunity to take part in this study. It’s something I can do for the hundreds of thousands of people who are still shielding and haven’t been able to return to any sort of normality.

“I’m so proud to be a participant, this research is so important and will hopefully add another layer of armour we desperately need.

“It’s so simple, I take the nasal spray twice a day and then speak to the team at Cardiff once a week to check any symptoms. I feel really safe as this drug isn’t new. The spray doesn’t affect the medication I’m on already and we will hopefully be able to see the results pretty soon.

“If we didn’t have studies like this one, I would be cooped up in my living room for the foreseeable future – so I’m happy to play my part in any way I can.”

Dr Nicola Williams, Director of Support and Delivery at Health and Care Research Wales said: “If successful, this nasal spray could be available to those with kidney and autoimmune diseases within months.

“Wales has played a huge part in the COVID-19 research response to help reduce the transmission and severity of this virus and we’re proud to again have multiple sites available for Welsh people to play their part.”