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临床试验/NCT04347408
NCT04347408已完成不适用

Seroprevalence of SARS-Cov-2 Antibodies in Children - a Prospective Multicentre Cohort Study

Queen's University, Belfast4 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2020年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
4
主要终点
Immunoglobulins (G and M) to SARS-Cov2 in Plasma

研究概览

简要总结

It is unknown what proportion of healthy children have been exposed to SARS-Cov-2 and how many have antibodies. The aim of this study is to follow a cohort of healthy children over six months and measure their antibodies to SARS-CoV-2.

详细描述

Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome. The majority of coronaviruses cause disease in a specific host species but some have infected humans by cross-species transmission. This process has led to a number of severe outbreaks of human disease including severe acute respiratory syndrome (SARS) in 2003 and Middle East respiratory syndrome (MERS) in 2012.

From December 2019 a novel infection "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2) was identified in the Wuhan region of China. The infection was identified as the causal factor in a growing number of severe cases of pneumonia. This disease was subsequently named coronavirus disease 2019 (COVID-19) by World Health Organisation (WHO). SARS-CoV-2 has been shown to cause severe disease similar to the previous SARS coronavirus from 2003. Severe disease is associated with pneumonia and damage to vital organs including lung, heart, liver, and kidney.

Fortunately SARS-CoV-2 appears to cause only mild, or no, symptoms in children.

The social distancing measures in the United Kingdom include the closure of schools and the cancelling of routine paediatric clinics. These drastic, but necessary, steps are likely to have a profound effect on the well-being of children.

This study is required to determine what proportion of children have been exposed to SARS-Cov-2 and how many, if any, have neutralizing antibodies. The findings from this study could be used to inform public health decisions regarding the re-opening of schools and other services vital to the well-being of children.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Month 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not currently receiving antibiotics, not admitted to hospital within the last seven days, not receiving immunosuppressive drugs and never diagnosed with a malignancy.
  • Admitted children with paediatric multisystem inflammatory syndrome and admitted children with other serious infections.

结局指标

主要结局

Immunoglobulins (G and M) to SARS-Cov2 in Plasma

时间窗: 6 months

• Mean antibody titres (IgG/Total antibody) to SARS-CoV-2 in plasma using ROCH/ABBOTT and DIASORIN assays

次要结局

  • Brain Natriuretic Peptide(6 months)
  • Echocardiogram Ejection Fraction(6 months)
  • High-sensitivity Cardiac Troponin Test(6 months)

研究者

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

Thomas Waterfield

Chief Investigator and Academic Clinical Lecturer

Queen's University, Belfast

研究点 (4)

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