PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: Addenbrookes Charitable Trust; Kidney Research UK (KRUK); LifeArc; UNION therapeutics
• Treatments: Niclosamide

Criteria

Inclusion Criteria:

• Be aged 18 years or older

• Have given written informed consent

• Be a member of one of the following vulnerable patients populations

• Dialysis - including in centre haemodialysis, home haemodialysis and peritoneal dialysis

• Kidney transplant receiving at least one of the immunosuppressive medications listed below

• Vasculitis (according to Chapel Hill Consensus Conference 2012 definitions) receiving at least one of the immunosuppressive medications listed below

• Glomerulonephritis* receiving at least one of the immunosuppressive medications listed below Ciclosporin Tacrolimus Azathioprine Mycophenolate Mofetil or Mycophenolic Acid Belatacept Methotrexate Tocilizumab Abatacept Leflunomide Prednisolone (current dose) > 20mg daily for 8 weeks Anti-TNF (infliximab, adalimumab, etanercept) Belimumab Cyclophosphamide (within the last 6 months) Rituximab (in the last 12 months) Alemtuzumab (in the last 12 months)

Exclusion Criteria:

• Inability to provide informed consent or to comply with trial procedures

• COVID-19 at time of enrolment - either positive SARS CoV-2 swab (PCR) or symptoms highly suggestive of COVID-19 infection

• Known chronic liver disease or hepatic dysfunction as evidenced by ALT or AST > 3x upper limit of the normal range

• Allergy to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipients used

• Significant structural nasal disease in the opinion of the investigator

• Pregnant, trying to conceive, unwilling to use contraception or breastfeeding

• Participation in another interventional prophylactic or vaccine trial* against COVID-19

• Patients remain eligible for enrolment if they have received SARS-COV-2 vaccination as part of routine care.