Assessment of the Serological Profile of Children and Adolescents Between 4 and 16 Years of Age Cohabiting With at Least One Family Member Who Tested Positive to COVID-19: an Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 y.o. cohabiting with at least a subject with a previous diagnosis of COVID-19.
研究概览
简要总结
Use of rapid serological tests to assess the vulnerability to SARS-CoV-2 infection of subjects aged 4-16 years old and cohabiting with at least one family member who tested positive to SARS-CoV-2
详细描述
Families with at least one child or young adult aged between 4 and 16 years old and with at least one cohabitant who tested positive to nasopharyngeal swab are contacted by phone. Those who decide to sign an informed consent after reading the study information will be included in the study. It consists of a preliminary telephone interview and a following rapid serological test for all children and young adults with the age included in the range of interest and the cohabitant who tested positive to nasopharingeal swab.
The obtained results will be collected and analysed, and the outcomes of the study will be measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and young adults aged between 4 and 16 years old with at least a Sars-Cov-2 positive cohabitant
- •Adults who previously tested positive to SARS-CoV-2 with at least a cohabitant aged between 4 and 16 y.o.
- •Subjects from the district of Sesto San Giovanni, Lombardy, Italy
排除标准
- •Children and young adults aged between 4 and 16 years old without at least a cohabitant who previously tested positive to SARS-CoV-2
- •Adults who previously tested positive to SARS-CoV-2 without at least a cohabitant aged between 4 and 16 y.o.
- •Absence of a signed informed consent
- •Subject with symptoms suggestive of COVID-19 in the last 14 days or disease in progress
结局指标
主要结局
Detection of IgG and IgM antibodies for Sars-Cov-2 in children aged between 4 and 16 y.o. cohabiting with at least a subject with a previous diagnosis of COVID-19.
时间窗: 1-30 days
Assessment of IgG and IgM using serological tests at a single time point.
次要结局
- Detection of IgG and IgM antibodies for Sars-Cov-2 in adults with a previous diagnosis of COVID-19 cohabiting with at least a child aged between 4 and 16 y.o.(1-30 days)
研究者
Marco Farronato
Principal Investigator
University of Milan