A Registry Study of COVID-19 Serologic and Virologic Testing to Accelerate Recovery and Transition (START) - Assessment of COVID19 Penetrance in HCW and Non HCW in Kentucky
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Prevalence of COVID-19
研究概览
简要总结
The co-primary objectives of this study are to:
- Determine and compare the COVID-19 antibody positivity rate in health care workers and patients without a known COVID-19 infection
- Determine if PCR negativity for COVID-19 early in quarantine predicts negativity at Day 14 in quarantining individuals
详细描述
This is a prospective cohort study designed to identify the prevalence of IgG antibodies to SARS CoV-2 as well as to assess risk factors for IgG positivity. It will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of PCR negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a COVID exposure.
In addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for COVID infection and provide a research blood sample. Quarantining individuals will also have standard of care PCR testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period.
Collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. An annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Individuals (health-care workers and patients) undergoing standard of care assessment of SARS-CoV-2 serology testing
- •Individuals with a COVID-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care SARS-CoV-2 PCR testing.
- •Able to understand and sign the Informed Consent and Research Authorization From.
排除标准
- •Prisoners
- •Patients with psychiatric illness that would limit compliance
- •Patients with social situations that would limit compliance
结局指标
主要结局
Prevalence of COVID-19
时间窗: 2 years
Proportion of people with IgG antibodies against SARS CoV-2 using a standard of care, Clinical Laboratory Improvement Amendments (CLIA), IgG antibody test.
次要结局
- PCR Conversion in Exposed Individuals(14 days)
研究者
Jill M Kolesar
Professor
University of Kentucky