PROTECT-V
Background
COVID-19 is an international health emergency that impacts the lives of all. There is an urgent need for medicines that can prevent or treat this infection. Numerous clinical trials are currently underway to investigate treatment options for COVID-19, however most of these studies exclude patients with complex medical conditions or advanced renal disease. In the absence of adequate information, we suspect that if an infection occurs, patients on dialysis and immunosuppressed patients will experience more symptoms than the public. Therefore, it is imperative to test medication that may prevent COVID-19 infection specifically in these patient groups.
The PROTECT-V trial is a collaboration between Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (United Kingdom) and The George Institute for Global Health India to run parallel protocols.
Aim
To determine if nasal Niclosamide reduces the risk of confirmed symptomatic COVID-19 infection in vulnerable renal and immunosuppressed patients.
Design
PROTECT-V is a double-blind placebo-controlled trial of prophylactic Niclosamide against SARS-CoV2 infection in vulnerable populations. The trial will enrol vulnerable patients with kidney or autoimmune diseases, including patients in receipt of dialysis, kidney transplant recipients, and individuals with vasculitis and glomerular disease receiving immunosuppression. The provisional distribution between trial populations will be 1:1:1. The sample size for PROTECT-V is 1500 participants, and approximately 750 participants will be enrolled in India.
Method
Randomisation 1:1 to Niclosamide or placebo nasal spray will be carried out using a web-based randomisation system, Sealed Envelope. The median anticipated intervention period is 6 months with a maximum intervention period of 9 months. Last follow-up visit will be scheduled 4-6 weeks after last dose. The primary outcome measure, symptomatic Covid-19 infection, will be compared between the two interventional groups in the Intention to Treat population using a Cox proportional hazards model.
Participants will be contacted by the local principal investigator or research staff for the purpose of collecting data. The researcher will inquire about the intervention received and any symptoms suggesting potential side effects of Niclosamide/placebo or of COVID-19 infection once every week for the first four weeks and fortnightly from the sixth week of the trial. The PI will review any concerns raised about the side effects of Niclosamide/placebo and decide about the continuation of the trial. A final safety assessment will be conducted in person, 4-6 weeks after the final intervention.
Current Status
The trial has completed recruitment in India and UK and is currently in the data cleaning/analysis stage.
