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临床试验/NCT04392388
NCT04392388已完成不适用

Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis - Serology

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 96,883 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96,883
试验地点
1
主要终点
Cumulative incidence of SARS-Cov2 infection in the general population.

研究概览

简要总结

This study aims to quantify and follow the cumulative incidence of SARS-CoV-2 infection in the French population using serological tests and to assess the determinants of infection from Constances, E3N-E4N, ELFE-Epipage 2 and NutriNet-Santé cohorts.

详细描述

The primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling.

The secondary objectives are:

  • To identify factors associated with a positive SARS-CoV-2 infection (positive serology) and to characterize the durability of the serological response to SARS-CoV-2
  • To identify associations of symptoms predictive of a SARS-CoV-2 infection
  • To estimate the health care use associated with a SARS-CoV-2 infection
  • To estimate the fraction of sub-clinical infections or infections not captured by the healthcare system;
  • To study the acceptability of a mass anti-SARS-CoV-2 serological testing and the impact of its result, linked with social inequalities in health;
  • To estimate the individual and collective impact of containment and other preventive measures on the risk of SARS-CoV-2 infection;
  • To study the impact of social and territorial inequalities on seroprevalence levels.

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

入选标准

  • non applicable, already enrolled in the cohorts

排除标准

  • non applicable

研究组 & 干预措施

SAPRIS-SERO

SAPRIS-SERO enrolls participants from cohorts entitled: Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé.

干预措施: Non applicable (Biological)

结局指标

主要结局

Cumulative incidence of SARS-Cov2 infection in the general population.

时间窗: 8 months

Simple and corrected estimate of the number of seropositive individuals/number of individuals at risk in different strata, based on weighting and calibration and taking into account the random cohort effect.

次要结局

  • Rate of use of care (medical care, hospitalization, center 15) linked to the occurrence of symptoms suggestive of a SARS-Cov2 infection, and share attributable to the infection(8 months)
  • Strengths of associations between socio-behavioral factors and level of seroprevalence(8 months)
  • Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants(8 months)
  • Proportion and intensity of use of barrier measures (hydroalcoholic gel, mask, social distancing, description of outings / reasons, duration, frequency) and association with the level of seroprevalence(8 months)
  • Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies(8 months)
  • Proportion of tests proposed, accepted, performed, based on social and demographic characteristics(8 months)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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