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临床试验/NCT04534608
NCT04534608Unknown不适用

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

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2020年5月11日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ania C. Muntau

Medical Director

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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