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临床试验/NCT04490811
NCT04490811Unknown不适用

Seroprevalence and Immunoprotection Against SARS-CoV2 in Children Hospitalized in Paris

Hôpital Necker-Enfants Malades1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2020年4月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
800
试验地点
1
主要终点
serological test

研究概览

简要总结

The paediatric population present mild or asymptomatic form of SARS-CoV-2 infection. This study asses the frequency of patients with SARS-CoV2 Antibodies (Ab) (seroprevalence) and the neutralizing typology of those Ab (immunoprotection) in children from 7 days to 18 years of age hospitalized for no more than 4 days and whose clinical status requires blood sample regardless of the symptoms Patients are included on a given day, after information, before blood sampling performed as part of the care. 500 µL of sera, normally discarded will be kept to perform SARS-Cov2 serology.

详细描述

Background of the study:

The fraction of undiagnosed cases is a critical epidemiological characteristic that modulates the epidemic potential of SARS-CoV-2 emerging respiratory virus. These subjects most often present themselves in benign or totally asymptomatic form, although they are likely to spread the virus in the general population. The containment strategy was implemented in France to reverse the exponential epidemic growth of infection.

A crucial issue is the specific study of the paediatric population because the prevalence of symptomatic infections is low and children are mostly mild and under-diagnosed. Children could frequently be asymptomatic carriers and act as a real reservoir for the spread of the virus. In these "sub-symptomatic" carriers, the viral load may be low, and it is possible that PCR nasal tests may be defective. The serological study is therefore essential because it will inform us about the speed and effectiveness of seroconversion and therefore about the immunoprotection of this subpopulation.

The rationale for the study is that the proportion of children who have developed immunoprotection is decisive in defining measures to control the epidemic. It is essential to assess the prevalence and typology of antibody responses in this population and to follow kinetics over time.

The many emerging atypical forms and in particular the post-infectious kawasaki-like forms have a very particular immunopathological profile that provides information on the natural history of the disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
7 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • any child over 7 days and under 18 years of age who has been hospitalized for no more than 4 days and who has a blood sample regardless of the symptoms;

排除标准

  • Any child under 7 days

结局指标

主要结局

serological test

时间窗: 48 weeks

Ab against SARS-CoV-2

次要结局

  • neutralizing Ab(48 weeks)
  • Immuno phenotyping(48 weeks)

研究者

发起方
Hôpital Necker-Enfants Malades
申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabelle Sermet-Gaudelus

Professor

Hôpital Necker-Enfants Malades

研究点 (1)

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