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临床试验/NCT05128435
NCT05128435已完成不适用

Coronavirus Pediatric Serological Study

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
1
主要终点
SARS-CoV-2 antibody levels in asymptomatic patients

研究概览

简要总结

The Coronavirus Pediatric Serological Study's aim is to provide a better insight of children's immune response after SARS-CoV-2 infection.

Serological tests were conducted on blood samples taken 3 to 5 months after the children's viral infection.

The study was performed in collaboration with the Institute of Medical Immunology, were antibody levels were measured and immunoglobulin subclasses profiles were studied.

详细描述

The hospital laboratory provided us the list of children under 15 years old tested for SARS-CoV-2 in Saint-Pierre Hospital (Brussels) by PCR on nasopharyngeal swab between March 1 2020 and December 31 2020.

The medical files of all children that were tested positive for SARS-CoV-2 were reviewed and clinical information was collected.

For each positive child, the family was contacted by phone 3 months after the proven viral infection in order to ask permission to take a single blood test.

Covid19 serologies were performed in the hospital laboratory, and blood samples were then sent to the Institute of Medical Immunology, were antibody levels and immunoglobulin subclasses were studied.

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
0 Months 至 179 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Tested positive for SARS-CoV-2 by PCR on naso-pharyngeal swab performed in Saint-Pierre Hospital (Brussels) between March 1 2020 and December 31 2020

排除标准

  • 未提供

结局指标

主要结局

SARS-CoV-2 antibody levels in asymptomatic patients

时间窗: 3 to 5 months after SARS-CoV-2 infection

Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who did not show any symptoms at the time of the viral infection

SARS-CoV-2 antibody levels in hospitalized patients

时间窗: 3 to 5 months after SARS-CoV-2 infection

Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children who required an hospitalisation at the time of the viral infection

SARS-CoV-2 antibody levels in mildly symptomatic patients

时间窗: 3 to 5 months after SARS-CoV-2 infection

Measurement of SARS-CoV-2 IgG (total and subclasses), IgA (total and subclasses) and IgM levels in the sera of children presenting mild symptoms at the time of the viral infection

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa Tomasi

Doctor (pediatrician)

Centre Hospitalier Universitaire Saint Pierre

研究点 (1)

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