The PROTECT-V (PROphylaxis for paTiEnts at risk of COVID-19 infecTion) is a platform designed to test drugs that may prevent Covid-19 infection in vulnerable patients with kidney disease or who are receiving immunosuppression. Covid-19 has had a huge impact these individuals. The rapid role out of vaccination has been very welcome news, but it is unclear if these patients will mount as strong responses to the vaccine as healthy individuals.
The first agent to be tested in the PROTECT-V trial is nasal niclosamide, an agent usually used to treat intestinal worms in tablet form. Niclosamide has shown real promise in the lab, with early tests revealing niclosamide could stop SARS-CoV-2 multiplying and entering cells of the upper airways. It will be randomised, double-blind, placebo-controlled and event-driven, evaluating the use of nasal niclosamide as a prophylactic agent against COVID-19 infection. Participants will be randomised 1:1 to niclosamide or matching placebo. At least 1500 participants will be enrolled from three vulnerable patient populations: dialysis patients, kidney transplant recipients and those with vasculitis or another auto-immune kidney disease/glomerulonephritis (GN).
The trial has now been awarded Urgent Public Health Prioritisation and will roll out across the UK in the coming weeks. Patient will continue to receive all their usual treatments and Covid-19 vaccination. The trial has been designed so that other promising preventative agents can easily be added to the trial platform.
In addition to government funding, the PROTECT-V trial is also 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 nasal niclosamide and matched placebo.