Registry of Sustained Immunity to COVID-19 Among ESKD Patients
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
- 否
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
