Registry of Sustained Immunity to COVID-19 Among ESKD Patients (RePAiR)
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.
研究概览
地位
详细说明
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.
Phase 2: Start will be triggered by the sponsor in the fall of 2020 and each geographic study location may be triggered to start at separate times. Study participants will be followed prospectively for incidence and severity of COVID-19. Study visits will commence upon sponsor trigger and will occur once monthly for 4 months.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Victorville、California、美国、92394
- DCR Victorville
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Connecticut
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Bridgeport、Connecticut、美国、06606
- DCR Connecticut
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Minnesota
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Minneapolis、Minnesota、美国、55404
- DCR Twin Cities
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Nevada
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Las Vegas、Nevada、美国、89128
- DCR Las Vegas
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New York
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Bronx、New York、美国、10461
- DCR Bronx
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Ohio
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Canton、Ohio、美国、44718
- DCR Canton
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Texas
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El Paso、Texas、美国、79925
- DCR El Paso
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Lewisville、Texas、美国、75057
- DCR Lewisville
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San Antonio、Texas、美国、78230
- DCR San Antonio
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San Antonio、Texas、美国、78215
- DCR San Antonio
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Virginia
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Norfolk、Virginia、美国、23502
- DCR Norfolk
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- DCR Milwaukee
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
- 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.
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Anti-SARS-CoV-2 antibodies
大体时间：Through study completion (5 visits), an average of 6 months
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Through study completion (5 visits), an average of 6 months
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Incidence and severity of COVID-19
大体时间：Through study completion (5 visits), an average of 6 months
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Through study completion (5 visits), an average of 6 months
|
合作者和调查者
调查人员
- 首席研究员：Francesca Tentori, MD、DaVita Clinical Research
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.