Prevalence of Infection and Seroconversion and the Clinical Course of the Novel Coronavirus SARS-CoV-2 Infection in Children Between 0 to 18 Years of Age in Hamburg and Surroundings
试验速览
- 阶段
- 不适用
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Acute infection by SARS-CoV-2
研究概览
简要总结
The study measures infection rates and the presence of antibodies for SARS-CoV-2 (COVID-19) among in- and outpatients of all pediatric hospitals, as well as volunteers aged 0 to 18 years in Hamburg, Germany. Participants with a positive nasopharyngeal swab PCR or a positive antibody test enter the Follow-up phase of 6 months. The follow up includes a PCR and antibody testing of all household contacts at 0, 3 and 6 months, as well as laboratory testing of children to identify immunological, metabolic and genetic risk factors for infection and clinical outcome.
详细描述
The study is divided into a Screening phase and a Follow-up phase. In the Screening phase, an obligatory polymerase chain reaction (PCR) in the nasopharyngeal swab and an optional serum antibody testing are carried out for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An obligatory standardized questionnaire is used to evaluate symptoms and contacts, medical history and underlying conditions and the psychological effects of the Coronavirus disease 2019 (COVID-19) pandemic, as well as its effects on individual access to medical care. Children with a positive nasopharyngeal swab or antibody test, as well as their household contacts aged 0 to 18 years enter the Follow-up phase. During the Follow-up phase, blood and urine samples are taken from children for immunological analysis, HLA typing and untargeted metabolomics, enabling a broad analysis of the adaptive and innate immune response to SARS-CoV-2, as well as metabolic and genetic risk factors for infection and disease compared to age and sex-matched healthy controls. Furthermore, a repeated swab and antibody testing at 0, 3 and 6 months for children and adult household contacts is carried out to analyse household transmission of SARS-CoV-2 in children and adults and the persistence of antibodies.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children or Teenagers aged 0-18 years
- •Patient in one of the participating centers or volunteer in the central C19.CHILD Study Clinic
- •Informed consent from parents or guardians.
- •Informed consent from children >7 years (unless not capable)
排除标准
- •Prematurity <37 weeks of gestation
- •Informed consent of parents and guardians not possible in spoken word or otherwise
- •Informed consent not given
结局指标
主要结局
Acute infection by SARS-CoV-2
时间窗: 6 weeks
Detection of SARS-CoV-2 by PCR in the nasopharyngeal swab
次要结局
- Seroconversion for SARS-CoV-2(6 months)
- Immune phenotyping(6 months)
- HLA Typing(6 months)
- Matabolomics(6 months)
研究者
Ania C. Muntau
Medical Director
Universitätsklinikum Hamburg-Eppendorf
