Clinical trial investigating if Niclosamide can prevent vulnerable patient groups developing COVID-19 disease

Research title

PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion (PROTECT-V): A basket trial of prophylactic interventions in multiple at-risk patient groups

Summary

A trial investigating the efficacy of Niclosamide as a preventative drug against COVID-19 infection in vulnerable patient groups including patients on dialysis, patients with vasculitis and transplant patients. This a basket trial design allowing for the addition of further interventions and patient groups at later time points. Where possible appointments and testing will be carried out remotely to avoid any undue risk to patients.

Research organisation

University of Cambridge

Researchers

Principal Investigators:

  • Dr Thomas Hiemstra
  • Dr Rona Smith, University of Cambridge

Co-investigators:

  • Dr Toby Humphrey, University of Cambridge
  • Prof James Wason, University of Newcastle
  • Dr Simon Bond, Cambridge Clinical Trials Unit
  • Prof Ian Wilkinson, University of Cambridge
  • Dr Fergus Caskey, University of Bristol
  • Prof James Burton, University of Leicester
  • Prof Patrick Mark, University of Glasgow
  • Prof Claire Sharpe, King’s College London
  • Prof Indranil Dasgupta, University of Warwick
  • Prof David Jayne, University of Cambridge
  • Dr Neil Basu, University of Glasgow

Potential of repurposed therapeutic for COVID-19 pandemic

In COVID-19 disease, the virus SARS-CoV-2 (the virus which causes COVID-19) enters the body and replicates in cells causing progressive respiratory symptoms and, in some cases, death.

Niclosamide is a generic drug that is commonly used to treat tapeworm and is listed as an essential medicine by the World Health Organisation and has a well-established safety profile. In the lab, Niclosamide has been shown to be a potent inhibitor of SARS-Cov-2 replication. Here it will be delivered by nasal inhalation, as the virus replicates mainly in the nasal epithelium, making nasal delivery by metered dose pump spay a promising method to deliver the drug as a prophylactic.

The trial is unique, as it aims to find a preventative treatment that is suitable and effective for vulnerable kidney patients who are normally excluded from clinical trials. This includes patients on dialysis, patients with vasculitis (an autoimmune disease-causing blood vessel inflammation that can affect the kidneys) and kidney transplant recipients. This patient group is at significant risk of complications associated with COVID-19 infection and has an increased mortality rate compared to the general population. Participants can be vaccinated against SARS-CoV-2 and still be enrolled in this trial, which will identify whether niclosamide can protect people from the virus either on its own, or in combination with the currently available vaccines.

The PROTECT-V trial is expected to last 15 months and is being led by the Cambridge University Hospitals NHS Trust and the University of Cambridge. It is funded by LifeArc, Kidney Research UK, the Addenbrooke’s Charitable Trust and is supported by the NIHR Cambridge Biomedical Research Centre. UNION Therapeutics is supplying the drug, UNI911,

At least 1,500 patients will be enrolled and will be randomised to receive either UNI911 or a placebo, along with their usual treatment. Initially, nasally delivered niclosamide will be tested in patients but other preventative treatments may be included in the trial at a later date. Where possible, there will be no face-to-face visits to reduce any undue risk, appointments will be carried out over the phone and data collected virtually. To confirm whether niclosamide is effective in preventing COVID-19 the study will measure the time to confirmed diagnosis of COVID-19 in patients as well as longer term outcomes in those that become infected.