What is the PROTECT-V trial?

PROTECT-V is a trial that was set up with funding from Kidney Research UK, LifeArc, Addenbrooke’s Charitable Trust and UNION therapeutics and support from the NIHR Cambridge Biomedical Research Centre to test drugs that may prevent Covid-19 infection in people on dialysis, people who have had a kidney transplant, and people with auto-immune diseases affecting the kidneys who require treatment to suppress their immune system. 

The first drug to be tested in the trial is niclosamide, a drug that is usually used in tablet form to treat tapeworms, but early lab tests showed that it could stop the virus that causes Covid-19 from multiplying and entering cells of the upper airways. For this study, niclosamide was reformulated into a nasal spray to deliver the drug directly to the lining of the nasal cavity twice a day. 

The trial began in February 2021 at Addenbrooke’s Hospital in Cambridge and has since received urgent public health badging and been rolled out to over 40 hospitals across the UK.  

The aim is to recruit at least 1,500 kidney patients across the UK and the team recently passed the exciting milestone of recruiting over 1,000 people. Trial participants are randomised to receive either a placebo (or dummy) drug, or niclosamide as a nasal spray to be taken twice a day for up to nine months in addition to all their usual treatments. 

PROTECT-V uses an innovative clinical trial design where scientists and doctors can test one or more potential treatments in several groups of patients. Niclosamide is the first drug to be tested, but the trial design means the research team can add in other drugs if they become available or study additional vulnerable patient groups, and several new drugs will be added to the trial in the coming months. 

International expansion

In an exciting new development that will both strengthen the study and potentially accelerate the results, the niclosamide arm of the PROTECT-V trial has now expanded to India. 

In India, the study is being sponsored by the George Institute for Global Health India and being led by Professor Vivekanand Jha. The team will aim to recruit at least 750 kidney patients and the first patients have already been enrolled. 

Professor Jha said: “"Finding an alternative way to protect this vulnerable population is an important unmet need. If effective, this will open a novel and cheap way to protect these people from Covid-19 using a drug already widely available in low- and middle-income countries."  

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:

“Covid-19 is a global pandemic and therefore collaborating internationally makes complete sense.  Not only will this strategy boost and diversify recruitment, it will hopefully mean that the drug could be used more widely more rapidly should it be shown to be effective at preventing Covid-19 infection.” 

Sandra Currie, chief executive of Kidney Research UK said: “We are delighted to see that this important trial has expanded to India. This expansion will help to accelerate the results of the trial, which could reveal a low cost and simple way to protect a huge number of people all over the world.”