NCT05042193已完成不适用
A Prospective Cohort Study of Immunoglobulin G (IgG) Dynamics Against SARS-Co
Everly Health1 个研究点 分布在 1 个国家目标入组 1,883 人开始时间: 2021年3月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,883
- 试验地点
- 1
- 主要终点
- To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
研究概览
简要总结
The primary objective of this study is to describe the longevity of IgG against SARS-CoV-2 infection or vaccination.
详细描述
This virtual clinical study will use a prospective design, to evaluate longevity and seroprevalence of IgG against SARS-CoV-2 in approximately 800 patients as measured by Dried Blood Spots via fingerstick using the Everlywell COVID-19 Antibody Test Home Collection Kit. Participants will be followed up to 9 months at 1, 3, 6 and 9 months after enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥ 18 years
- •Willing to provide informed consent prior to participation.
- •Cohort 1 (Arm 1) - Positive test results for SARS-CoV-2 virus by an RT-PCR or Antigen test AND not received any COVID-19 vaccine or participated in any COVID-19 vaccine trial
- •Cohort 2 (Arm 2) - Received the COVID-19 vaccine
排除标准
- •Unable or unwilling to provide informed consent
- •Individuals with known conditions or treatments associated with immune impairment, such as cancer and chemotherapy
结局指标
主要结局
To describe the longevity and seroprevalence of IgG against SARS-CoV-2 in a cohort of individuals exposed to SARS-CoV-2
时间窗: Up to 9 months
次要结局
- To compare the off-kinetics of IgG positivity against SARS-CoV-2, stratified by age, sex, race, ethnicity, infection symptomaticity, initial viral load(Up to 9 months)
- To compare the off-kinetics of IgG positivity against SARS-CoV-2 by natural infection vs vaccination(Up to 9 months)
研究者
研究点 (1)
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