Prospective, Seroepidemiological, Non-invasive Cohort Study in Tübingen Children Age-stratified by Nursery and School Attendance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,380
- 试验地点
- 1
- 主要终点
- Incidence of SARS-CoV-2 infection in infants, children and adolescents
研究概览
简要总结
This is a prospective, longitudinal study to determine the incidence of SARS-COV-2 infection in children and adolescents by measuring specific antibodies in non-invasive saliva sampled in kindergartens and schools in a defined city area. The study includes an additional arm to validate the ELISA for anti-SARS-COV-2 reactive antibody measurements in saliva compared against blood collected in adult volunteers in a bimonthly follow-up period for 12 months.
详细描述
The world is confronting Coronavirus Disease-2019 (COVID-19) pandemic caused by SARS-CoV-2 virus, which is causing many deaths and burden on intensive care facilities. Data regarding epidemiologic characteristics in children and young adults is limited, especially in the context of educational settings. Due to mild symptoms or even asymptomatic cases in children, the rate of SARS-CoV-2 infected children is underestimated. Therefore, the present study aims to determine the incidence of SARS-CoV-2 infection in children at 3 timepoints during 12 months expressed as seroconversion measured in non-invasive saliva sampling in Tübingen, a defined study area. Children and adolescents (N = 1850) in the age of 1 to 17 years will be recruited via child-care, kindergarten and primary and secondary schools and followed-up for 12 months: shortly after release of lock-down measures in summer 2020, before winter and after the winter. An adult cohort (adult comparator group) is sampled at the same time points for incidence comparisons. To validate the ELISA for SARS-CoV-2 antibody measurements in saliva compared to blood, and to understand the half-life of SARS-CoV-2 antibodies in respective body fluids, peripheral blood and in saliva will be sampled every 2 months in an additional adult group (adult validation group).
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
- 1 Year 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children from 1 months to 18 years
- •Written informed consent of the parent/legal guardian (study population is minor)
- •Written assent when children are ≥ 12 years
- •Enrolled in a kita, kindergarden, primary, or secondary school located in Tübingen
- •Adult population:
- •Individuals >18 years who recovered from a confirmed SARS-CoV-2 infection.
- •Or individuals > 18 years with an unknown status of previous SARS-CoV-2 infection
排除标准
- •Unwilling to give consent
结局指标
主要结局
Incidence of SARS-CoV-2 infection in infants, children and adolescents
时间窗: 12 months
Identification of children that have been infected over different periods of time (summer, before winter and after winter) based on saliva samples
次要结局
- Incidence of SARS-CoV-2(12 months)
