PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
COVID-19 (novel coronavirus-induced disease) was declared a global pandemic by the WHO on
11th March 2020. Currently there are no drugs proven to prevent COVID-19 or to reduce the
severity of illness if given as prophylaxis. Although vaccines are now available, there
remains a need for other prophylactic agents until vaccine use becomes widespread globally
and effectiveness and durability is established, particularly in immunocompromised
individuals. Efforts are underway to repurpose established drugs with well understood drug
interactions and safety profiles.
The PROTECT-V is a platform clinical trial and aims to enrol patients at particularly high
risk of COVID-19 and its complications. the first agent to be tested is nasal nicolosamide
treatment as a prophylactic measure that either might prevent the disease from occurring or
may reduce the number of cases where the disease becomes serious or life-threatening.
PROTECT-V is a randomised, double blind, placebo controlled event driven trial.
Patients will be eligible for recruitment to the trial if they fall within one of the
following vulnerable populations: a)patients receiving dialysis, b)kidney transplant
patients, c)patients with vasculitis or glomerulonephritis.
Approximately 1500 participants will be randomised to active treatment or placebo, stratified
by PROTECT sub-population, age and participating sites. Enrolment to the trial will be via an
online platform following informed consent with a face to face screening visit. Subsequent
assessments, aside from an in person end of trial visit, will be done via email or telephone
together with utilising the routine collected health data thus reducing the burden to
participants as well as reducing their exposure to COVID-19.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborators:
Addenbrookes Charitable Trust Kidney Research UK (KRUK) LifeArc UNION therapeutics