Initial and Sustained Immunity to SARS-CoV-2 Measured by Serologic Assays on an Automated Immunoassay System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 829
- 试验地点
- 1
- 主要终点
- Detection of antibodies to SARS-CoV-2 in human serum and plasma
研究概览
简要总结
The primary objective is to assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months.
详细描述
The design strategy for this study is to validate the detection of COVID-19 antibodies in subjects at HFHS who test positive with RT-PCR for SARS-CoV-2 using fully automated test systems already in the core automated laboratory at HFH. This is a study of the immune response and kidney health of subjects who have recovered from COVID-19 infection.
There are 4 aims:
Aim 1. Assess detection of COVID-19 antibodies in subjects before discharge from HFHS who tested positive with RT-PCR for SARS-CoV-2 using fully automated immunoassays.
Aim 2. Evaluate emergence of immunity over a one-year period in subjects who tested positive with RT-PCR for SARS-CoV-2 using a fully-automated immunoassays.
Aim 3. Monitor renal function and kidney health at 6 and 12- months post diagnosis with COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients ≥18 years of age
- •Positive COVID-19 by RT-PCR SARS-CoV-2 assay
- •Patients must have a serum sample stored by pathology or within the TCRC biorepository around the date of their COVID-19 RT-PCR positive test
排除标准
- •< 18 years of age
- •negative for RT-PCR
- •no serum sample
结局指标
主要结局
Detection of antibodies to SARS-CoV-2 in human serum and plasma
时间窗: 12 months
The study will assess the ability of COVID-19 IgG and IgM assays to detect an immune response in COVID-19 patients in the Henry Ford Health System (HFHS), both during hospitalization and over the following 12 months. The study will use Beckman Coulter anti-Spike IgG assay and Roche anti-Nucleocapsid assay.
次要结局
未报告次要终点
研究者
Bernard Cook
Division Head, Chemistry-Pathology
Henry Ford Health System