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临床试验/NCT04495764
NCT04495764已完成不适用

Registry of Sustained Immunity to COVID-19 Among ESKD Patients

Davita Clinical Research11 个研究点 分布在 1 个国家目标入组 2,315 人开始时间: 2020年7月20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
2,315
试验地点
11
主要终点
Incidence and severity of COVID-19

研究概览

简要总结

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

详细描述

This is a multi-center, prospective registry study of subjects undergoing hemodialysis for treatment of end-stage renal disease in a DaVita center.

The objective of this study is to understand whether and to what degree anti-SARS-CoV-2 antibodies mitigate the risk of subsequent SARS-CoV-2 infection and COVID disease within the ESKD population.

Following informed consent, participants will undergo baseline serologic characterization for anti-SARS-CoV-2 IgM and IgG. The study is planned to align with the present wave of COVID-19. Enrollment will continue until the total sample size of 2500 is reached or until the study sponsor determines. Should there be a subsequent wave of COVID- 19, participants will be actively surveiled for evidence of SARS-CoV-2 infection and for COVID-19 disease. The relationship between baseline serologic status and subsequent infection/disease will be determined.

This study will have 2 distinct phases.

Phase 1 (baseline characterization) start will be triggered by the sponsor and may start at different times at the active sites. Participants will be consented and enrolled and blood will be collected for anti-SARS-CoV-2 antibodies.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between ≥18 and 80 years of age, inclusive.
  • Ability to provide informed consent.
  • Currently receiving hemodialysis treatment for end-stage kidney disease at a DaVita dialysis center.

排除标准

  • 未提供

结局指标

主要结局

Incidence and severity of COVID-19

时间窗: Through study completion (5 visits), an average of 6 months

Anti-SARS-CoV-2 antibodies

时间窗: Through study completion (5 visits), 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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