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临床试验/NCT04495907
NCT04495907已完成不适用

COVID-19 Progression in End-Stage Kidney Disease

Davita Clinical Research11 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2020年8月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
412
试验地点
11
主要终点
SARS-CoV-2 IgG

研究概览

简要总结

The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.

详细描述

COVID-19 is a novel illness caused by the SARS-CoV-2 virus. It was declared as a global pandemic on March 11, 2020 and since that time there have been outbreaks on every continent except for Antarctica. Preliminary understanding of the virus suggests that some fraction of the population does not manifest clinical disease in response to infection, others manifest a relatively benign course of illness, and still others develop a fulminant course that eventuates in the need for intensive care, mechanical ventilation, or even death. The genetic and epigenetic basis for differential susceptibility remains unknown.

Patients receiving hemodialysis provide a good opportunity to understand genetic and epigenetic susceptibility to SARS-CoV-2. By virtue of their ongoing requirements for care, such patients cannot shelter at home or maintain social distancing, but must instead report to a clinical care setting on a thrice weekly basis. Moreover, such patients often travel to and from dialysis using shared ride services, which furthers opportunity for exposure. Preliminary estimates suggest that rates of SARS-CoV-2 positivity are 2 to 5-fold higher among hemodialysis patients than in the general public. Furthermore, frequent contact with the health care system among dialysis patients makes tracking clinical course comparatively easy.

The purpose of this study is to collect genomic and clinical data among a cohort of hemodialysis patients and analyze the association between genetic markers and the development and severity of illness in response to SARS-CoV-2.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Is 18 years or older at the time of consent
  • Ability to provide informed consent.
  • Is currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.
  • Enrollment in prior genomics study (Additional criteria for type B only)

排除标准

  • 未提供

结局指标

主要结局

SARS-CoV-2 IgG

时间窗: An average of 6 months

Anti-SARS-CoV-2 IgG

时间窗: An average of 6 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

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