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Clinical Trials/EUCTR2020-004144-28-GB
EUCTR2020-004144-28-GB
Active, not recruiting
Phase 1

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

Cambridge university Hosptials NHS Foundation Trust and University of Cambridge0 sites1,500 target enrollmentOctober 15, 2020
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Cambridge university Hosptials NHS Foundation Trust and University of Cambridge
Enrollment
1500
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 15, 2020
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Cambridge university Hosptials NHS Foundation Trust and University of Cambridge

Eligibility Criteria

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
  • •Azathioprine
  • •Mycophenolate Mofetil or Mycophenolic Acid

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

Outcomes

Primary Outcomes

Not specified

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