SARS-CoV-2 Infections in Children and Adolescents: Course of COVID-19, Immune Responses, Complications and Long-term Consequences in Entire Households With Members Younger Than 18 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- age-dependence of SARS-CoV-2 infection
研究概览
简要总结
Longitudinal study of 56 households with at least one member who had COVID-19 to compare the course of illness, immune responses, and long-term consequences of SARS-CoV-2 infection in HED patients with those of control subjects of the same age group. Complete households are investigated, including women who are pregnant when exposed to the virus and their newborn child(ren).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •household with one or more members registered as patient(s) in the University Hospital Erlangen
- •at least one person <18 years of age
- •at least one household member who has or had a SARS-CoV-2 infection confirmed by a positive PCR test, detection of specific antibodies against this virus, or by development of COVID-19 symptoms after being in close contact with a person known to be infected with SARS-CoV-2
- •informed consent
排除标准
- •missing informed consent of one or more household members
- •language barriers to communication that would prevent informed consent
结局指标
主要结局
age-dependence of SARS-CoV-2 infection
时间窗: 3 months from the point in time at which the first household member shows symptoms of COVID-19
registry of household members with and without symptoms of COVID-19 (entire households)
percentage of household members infected by SARS-CoV-2
时间窗: 3 months from the point in time at which the first household member shows symptoms of COVID-19
The infection rate is determined on the basis of specific PCR tests and detectibility of antibodies against SARS-CoV-2.
duration of primary COVID-19 symptoms
时间窗: 2 months from the onset of COVID-19 symptoms
The possible association between the length of time with symptoms of COVID-19 and specific immune responses, in particular the development of virus-neutralizing antibodies, is studied.
frequency of postviral fatigue
时间窗: 2-12 months from the onset of COVID-19 symptoms
Patient-reported symptoms of fatigue are registered (questionnaire).
frequency of noticeable temporary hair loss after COVID-19
时间窗: 2-12 months from the onset of COVID-19 symptoms
Patient-reported extent of hair loss is registered (questionnaire).
frequency of late-onset cardiovascular complications
时间窗: 2-12 months from the onset of COVID-19 symptoms
Patient-reported known and yet unknown long-term consequences of COVID-19 are registered and investigated further (questionnaire, specific data confirmed by clinical examination).
次要结局
未报告次要终点
研究者
Prof. Dr. Holm Schneider
Head, Center of Ectodermal Dysplasias
University Hospital Erlangen