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临床试验/NCT04615000
NCT04615000已完成不适用

SeroCovid<19: A Prospective Covid-19 Seroconversion Study in a Tertiary Pediatric Patient Cohort

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2020年10月29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
362
试验地点
1
主要终点
Seroconversion rate of children with chronic conditions followed in a tertiary centre

研究概览

简要总结

Children are relatively spared from the direct clinical impact of COVID-19. Pediatric patients with regular follow-up at tertiary pediatric centres and presenting one or more chronic conditions might be at increased risk for severe COVID-19. With a prospective seroprevalence study, we aim to study COVID-19 incidence, disease course and risk factors associated with SARS-CoV-2 infection in this specific context.

详细描述

Children and adolescents seem to be relatively spared from severe SARS-CoV-2 infection. Throughout the course of the COVID-19 pandemic, these findings were confirmed with, for example, also in Belgium only 1.8% of the confirmed infections, 1.6% of the hospitalizations in intensive care, and 0.011% of the deaths from COVID-19 attributed to children by the end of May 2020. Multiple immunological hypotheses (ACE2 expression, lymphocyte repertoire, cross immunization) have been suggested without one clear explanation to date. In addition, children seem to play a limited role in the spread of the virus and are not considered the "engine of the epidemic".

Population seroconversion studies have been initiated with the determination of antibodies to SARS-CoV-2. For Belgium, seroconversion rates were estimated at around 2.1% at the end of March, 4.3% in mid-April, 6% at the beginning of May and 6.9% at the end of May 2020, comparable to international studies. However, even with these prospective studies, it remained unclear whether the seroconversion rate in children is comparable to adults. In addition, it has not yet been demonstrated whether the mild course and limited hospitalizations in children are related to either a mild course or (in part) also to a lack of exposure to SARS-CoV-2 and therefore limited seroconversion in children.

With this study we aim to monitor both the presence of antibodies (serology) in children with chronic disease, followed in a tertiary hospital in Belgium, combined with the registration of the clinical course of COVID-19 in this population. In addition, we want to correlate the social activities with the risk of exposure to the virus and subsequent seroconversion. Blood samples for serology are performed at a 3- to 6-month interval, linked to an already planned blood sample for diagnostic reasons. This data will allow to gain more insight into the actual rate of infection and the symptoms caused by COVID-19 in children with a chronic disease, on the one hand, and, on the other hand, how the social behavior, limited by the lockdown measures or after its progressive relaxation, affects seroconversion in these pediatric populations. These data may or may not confirm current hypotheses about infection rate and clinic severity and will also influence current and future policies such as closing schools and defining at-risk populations.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children <18 years of age
  • a clearly defined chronic condition requiring follow-up at the tertiary pediatric hospital of the Ghent University Hospital
  • routine blood sampling planned per 3 to 6 months

排除标准

  • no clear diagnosis or reason for follow-up at the Ghent University Hospital
  • no routine blood sampling planned
  • unable to understand or provide informed consent

结局指标

主要结局

Seroconversion rate of children with chronic conditions followed in a tertiary centre

时间窗: 12-18 months

Prospective follow-up of the COVID-19 seroconversion rate (serum IgG) of children with chronic conditions followed in a tertiary centre

次要结局

  • Epidemiological and social determinants of SARS-CoV-2 infection risk in children with chronic conditions(12-18 months)
  • Clinical manifestations of COVID-19 in children with chronic conditions(12-18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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