COVID-19 Antibody and Reinfection Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,235
- 试验地点
- 1
- 主要终点
- Reinfection With SARS-CoV-2
研究概览
简要总结
The goal of this study is to establish a cohort of Kaiser Permanente Colorado (KPCO) members who have and have not had COVID-19 infection for serial antibody testing and PCR testing to:
- Quantify antibody titers among participants over 9 months.
- Determine the rates of asymptomatic, mild, and severe recurrent infection among participants with prior COVID-19.
- Examine association between antibody titer levels and risk of recurrent infection using a case control analysis nested in the cohort.
详细描述
In this study, the Kaiser Permanente Colorado (KPCO) Institute for Health Research (IHR) will evaluate SARS-CoV-2 IgG antibody titers over time among individuals with evidence of prior infection, and correlate antibody titers with risk of recurrent infection. The investigators will identify KPCO members who have and have not had prior infection, enroll them into a cohort study, conduct serial surveys for new COVID-19 symptoms, and facilitate serial viral and antibody testing.
All laboratory testing procedures and clinical management of participants will be conducted by KPCO operations. The research team will identify participants, obtain consent, administer surveys to assess COVID-19 symptoms, and direct patients to the appropriate testing. Health outcomes on cohort participants will be tracked with survey data on symptoms, clinical and utilization data from the KPCO electronic health record (e.g., hospitalization), and laboratory data (e.g., viral test results).
This research-operations partnership strategy will generate data to better understand the implications of positive antibody titers to this novel pathogen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Reinfection With SARS-CoV-2
时间窗: Through the completion of the study analytic period, an average of 6 months
In this case-control analysis, case patients were participants with the outcome of reinfection. The date of reinfection was the index date. Control patients were those with a primary infection but without the outcome reinfection by the index date. The case and control participants were compared with respect to a seronegative test result (exposure) after primary infection and closest in time to the index date. Because the cases and controls were selected on the basis of the outcome, the seronegative result is listed below by case and control status.
次要结局
未报告次要终点
研究者
Ingrid Binswanger
Senior Investigator
Kaiser Permanente