EUCTR2020-004144-28-GB进行中（未招募）1 期
PROphylaxis for paTiEnts at risk of COVID-19 infecTion - PROTECT
Cambridge university Hosptials NHS Foundation Trust and University of Cambridge0 个研究点目标入组 1,500 人开始时间: 2020年10月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •? 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
- •Methotrexate
- •Tocilizumab
- •Leflunomide
- •Prednisolone current dose > 20mg daily for 8 weeks
- •Anti-TNF (infliximab, adalimumab, etanercept)
- •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
排除标准
- •? 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
研究者
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