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临床试验/NCT04872751
NCT04872751Unknown不适用

The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study

Penang Hospital, Malaysia1 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2021年4月27日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
425
试验地点
1
主要终点
Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level

研究概览

简要总结

The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination

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

  • ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
  • 18 years old and above
  • consented to join the study

排除标准

  • patient who refused to be vaccinated
  • patient who deemed unsuitable for Covid vaccination

结局指标

主要结局

Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level

时间窗: up to one year

Study the antibody synthesis induced by vaccination, among end stage renal failure patients, and the change in its level at 1 month, at 6 months and at 1 year after complete vaccination.

次要结局

  • Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)(one month)

研究者

发起方
Penang Hospital, Malaysia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr.Ong Loke Meng

Doctor

Penang Hospital, Malaysia

研究点 (1)

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