A Prospective Study of COVID-19 and Related Outcomes in School Aged Children (ABC Health Outcomes in Children)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C).
研究概览
简要总结
This is a prospective, observational study with a primary objective of determining the incidence of non-severe and severe COVID-19, including MIS-C, among eligible children who are diagnosed with COVID-19 and consent (or assent) to collection of data on risk factors using a unique direct-to-participant, direct-to-family, and direct-to-community approach. Secondary and exploratory objectives include risk factors of severe disease and quality of life (QoL).
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is ≤ 21 years of age at time of enrollment
- •Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative (Pro00107785) and has agreed to the App's Terms of Use
- •Participant has a positive COVID-19 diagnosis, defined as one or more of the following:
- •A positive COVID-19 test; or
- •Clinical diagnosis of COVID-19 based on symptoms, as documented by a medical provider, in the absence of a positive influenza test; or
- •Retrograde diagnosis based on presence of COVID-19 antibodies
排除标准
- 未提供
结局指标
主要结局
Describe the incidence of non-severe and severe COVID-19, including Multisystem Inflammatory Syndrome in Children (MIS-C).
时间窗: 90 days
Number of participants who report non-severe or severe COVID-19 disease (defined as a hospitalization event, severe neurological dysfunction, occurrence of MIS-C, or death within 90 days of infection with SARS-CoV-2), reported as a proportion (%) of the total number of participants enrolled in the study who develop non-severe and severe COVID-19 from the time of study initiation to the end of study.
次要结局
- Characterize outcomes associated with COVID-19 in children.(Up to 5 years)
- Describe characteristics of participants who attend in-person versus virtual classes.(Up to 5 years)
- Describe risk factors of non-severe and severe COVID-19.(Up to 5 years)
- Describe the duration of in-person school attendance.(Up to 5 years)