DCI COVID-19 Surveillance Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of COVID-19 reinfection
研究概览
简要总结
This is a prospective longitudinal census study conducted at a single center (DCI Inc., Henry Avenue, Philadelphia). The purpose of this study is to gain information about COVID-19 infection and antibody response in an in-center dialysis population. The investigators hypothesize that screening and surveillance for COVID-19 positive test (viral infection) and antibodies response to infection (potential immunity) in a dialysis center population within a high-prevalence region can provide foundational information to guide approaches toward prevention of COVID-19 related illness in a susceptible population. Participants will be given a questionnaire initially and monthly over the study period to find out whether they have had COVID-19 infection, hospitalization, or symptoms. A nasopharyngeal swab test for COVID-19 infection and a blood sample for COVID-19 antibody will be collected monthly for the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive in-center chronic dialysis (>3 months) at DCI Henry Avenue
- •Patients who are able to consent for study
排除标准
- •Patients receiving transient hemodialysis at DCI or receiving hemodialysis for Acute Renal Failure
- •Patients who are unable to consent
- •Patients who are receiving other forms of dialysis therapy (e.g. home hemodialysis, peritoneal dialysis)
- •Patients whose life expectancy is <12 months
- •Patients who are planning to leave the dialysis center within 12 months
结局指标
主要结局
Incidence of COVID-19 reinfection
时间窗: monthly through study completion (average of 18 months)
COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel
Incidence of COVID-19 infection in the cohort
时间窗: monthly through study completion (average of 18 months)
COVID-19 infection assessed using the Hologic Aptima SARS-CoV-2 Assay and/or the Luminex NxTAG SARS-CoV-2 Extended Panel
Link the presence of COVID-19 infection to COVID-19 antibody formation (seroconversion) from qualitative testing
时间窗: monthly through study completion (average of 18 months)
Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
Presence of antibodies in cases of reinfection
时间窗: monthly through study completion (average of 18 months)
Antibody formation assessed using the Beckman Coulter Access SARS-CoV-2 IgG Antibody Test
次要结局
未报告次要终点