EUCTR2021-000988-68-SE进行中（未招募）1 期
Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 . - RenalCoV
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 性别
- All
入选标准
- •- Adult 18-65 years old.
- •- Chronic renal failure stadium 4 or 5 with or without dialysis.
- •- The study patient has given her/his consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Previous renal transplantation
- •- Concomitant medication with immune-modulating agent
- •- Current or previous known covid-19 infection at inclusion (i.e previous PCR positive for SARS-CoV-2 or previous detection of SARS-CoV-s antibodies).
- •Antibodies detected during screening for this study is not an exclusion criterion.
- •- Information in the Health declaration for covid-19 vaccination (17) which suggests that vaccination is inappropriate.
- •- Vaccinated or planned vaccination with other vaccine within the next 14 days that can not be rescheduled.
- •- Pregnancy
- •- Hypersensitivity for any substance in the vaccine
- •- Mental impairment, reluctance to participate or language difficulties which entail difficulties to understand the implication of the study
- •- Individual who is not considered appropriate for study participation due to any other reason.
研究者
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