PROphylaxis for paTiEnts at risk of COVID-19 infecTion - PROTECT

Phase 1

• Registration Number: EUCTR2020-004144-28-GB
• Lead Sponsor: Cambridge university Hosptials NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1500

Inclusion Criteria

? Be aged 18 years or older
? Have given written informed consent to participate
? 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)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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
? Previous confirmed COVID-19
? 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 on the investigator
? Pregnant, trying to conceive, unwilling to use contraception or breastfeeding
? Participation in another prophylactic or vaccine trial against COVID-19

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified