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临床试验/NCT04743947
NCT04743947招募中不适用

Observational Study on the Effects of SARS-CoV-2 Vaccination in Dialysis and Kidney Transplant Patients

Heinrich-Heine University, Duesseldorf5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
5
主要终点
SARS-CoV-2- antibody- titer

研究概览

简要总结

This is a prospective, multi-center, observational study that will enroll patients receiving dialysis (hemodialysis or peritoneal dialysis) or patients with kidney transplantation who will be vaccinated against COVID-19.

详细描述

Patients on dialysis and kidney transplant patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus type 2) have an increased risk to develop a more severe course of disease or die from COVID-19 (coronavirus disease 2019). SARS-CoV-2 vaccination can increase protection against COVID-19. Kidney transplant patients and patients requiring dialysis suffer from an acquired immune deficiency. Due to the dysfunctional immune response, the general vaccine response in dialysis patients and kidney transplant patients is in many cases insufficient.

Until now, the vaccination response in dialysis patients and kidney-transplanted patients is unpredictable. Verification of vaccine response can provide important information on how to treat and protect these patients from a COVID-19. Therefore, there is a medical need to monitor vaccine protection after SARS-CoV-2 vaccination in clinical practice. In this observational study, data of the SARS-CoV-2 vaccination response collected in clinical routine will be analyzed from these patients. Based on this observational study, the investigators aim to get first evidence whether and to what extent vaccination against COVID-19 causes a vaccine response in immunocompromised patients with kidney disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving dialysis (hemodialysis or peritoneal dialysis)
  • capable of giving consent
  • age 18 or older

排除标准

  • non-capable of giving consent

结局指标

主要结局

SARS-CoV-2- antibody- titer

时间窗: 2 years

SARS-CoV-2- antibody- titer after vaccine

次要结局

未报告次要终点

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

PD Dr. med. Johannes Stegbauer

Assistant Professor

Heinrich-Heine University, Duesseldorf

研究点 (5)

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