EUCTR2021-001520-18-NL进行中（未招募）1 期
ong term efficacy and safety of SARS-CoV-2 vaccination in Dutch patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation - The LESS CoV-2 study
RECOVAC consortium0 个研究点目标入组 24,300 人开始时间: 2021年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24,300
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
- •1.Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
- •2.Age of 18 years or older
- •3.Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
- •-eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
- •-Hemodialysis, or peritoneal dialysis
- •-Kidney Transplant recipient at least 6 weeks after transplantation
- •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 8000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4000
排除标准
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
- •Patients who opted out for research in the Santeon, RENINE and NOTR registries.
- •Patients who participate in the RECOVAC-IR study.
研究者
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