Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,006
- 试验地点
- 2
- 主要终点
- Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity
研究概览
简要总结
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area.
A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted.
The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study
详细描述
In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. To date, these estimates are based on RT-qPCR tests carried out on individuals with symptoms of the disease, on people likely to present severe forms of COVID-19, known as 'vulnerable', or on the number of hospitalizations/deaths related to COVID-19. In order to refine these estimates, it is crucial to carry out measurements on a random sample of the population and to take biological samples for serological testing, in accordance with the recommendations of the HAS and the scientific societies.
Besides, it is important to assess the proportion of persons reporting that they have not developed symptoms of COVID-19 since the beginning of the epidemic among seropositive persons.
The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area.
A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the GNM population randomly selected.
It is a cross-sectional, not experimental study in the sense that it does not alter the exposure of participants; however, it does require a blood sample, which classifies it as minimal risk intervention research according to French law. The study is monocentric.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Person who has received full information about the research organization and signed informed consent
- •Person residing in the Grand Nancy Metropolitan area
- •Person aged at least 5 years on 1 June 2020 and weighing more than 7 kg
排除标准
- •Children under 5 years of age at the time of collection
- •Person referred to in Articles L1121-8 of the Public Health Code. A person of full age who is subject to a legal protection measure (guardianship, curatorship, legal protection).
- •Adult person unable to give consent
- •Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1.
结局指标
主要结局
Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity
时间窗: through study completion, an average of 4 hours
Anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area
次要结局
- Proportion of asymptomatic, symptomatic cases among seropositive people(through study completion, an average of 4 hours)
- Proportion of infected households(through study completion, an average of 4 hours)
- Anti-SARS-CoV-2 IgT seropositivity in the household(through study completion, an average of 4 hours)
- Proportion of asymptomatic cases among seropositive people(through study completion, an average of 4 hours)
- Identification of risk groups - Anti-SARS-CoV-2 IgT seropositivity by age, sex and as a function of weight status, smoking status, work activity and social status.(through study completion, an average of 4 hours)
- Proportion of seropositive subjects according to the level of social disadvantage measured by the EPICES score(through study completion, an average of 4 hours)
- Clinical expression patterns of infection by symptom/antibody association(through study completion, an average of 4 hours)
- Serological Response to Infection(through study completion, an average of 4 hours)
- Anti-SARS-CoV-2 IgT seropositivity(through study completion, an average of 4 hours)
- • Evaluation of serum neutralisation of persons positive for anti-SARS-CoV-2 antibodies, of the infectivity of viral strains in cell culture: percentage neutralisation compared to a viral strain not exposed to seropositive serum.(through study completion, an average of 4 hours)
研究者
Evelyne Schvoerer
Pr
Central Hospital, Nancy, France