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临床试验/NCT04607941
NCT04607941已完成不适用

Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 766,818 人开始时间: 2020年10月27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
766,818
试验地点
2
主要终点
Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire

研究概览

简要总结

The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.

It is a case-control study including :

  • cases identified by the nationwide system of positive SARS-CoV-2 tests (COVID-19 diagnosis information system, SIDEP) (currently limited to qRT-PCR) and invited to participate by the National Health Insurance (CNAM) which hosts the data from the nationwide test system;
  • controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories), gender and geographic area (departement);
  • cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.

Data will be collected via a self-administered online questionnaire. Some of the participants will be called for a complementary telephone questionnaire to measure reliability of online retrieved data and explore more specific aspects of SARS-CoV-2 transmission.

详细描述

The objective of the study is to identify socio-demographic factors, behaviors and practices associated with infection with SARS-CoV-2 to help determine where and how patients mostly get infected with SARS-CoV-2.

The study will focus on sociodemographic data (age, gender, location of residence, socio-economic level, etc.), behaviors and practices (adherence to hand-washing, mask-wearing, work habits, meetings, etc.), the places they visit (public transportation, bars, restaurants, sport facilities, etc.).

It is a case-control study including :

  • cases identified by the nationwide system of positive SARS-CoV-2 tests (SIDEP) (currently limited to RT-PCR) and invited to participate by CNAM, which hosts the data from the nationwide test system, through a nationwide email campaign sent once a week; cases will be asked if they can tell where they most probably were infected, leading to a detailed description of the circumstances of the contamination, including whether the suspected contamination took place within the household or not.
  • controls included via Ipsos, a polling institute with access to personal data from a panel from which they will include controls matched on age (divided into 10-year categories up to 68 years old included as expected adherence to an online questionnaire quickly drops beyond that age), gender and geographic area (departement); invitations will be sent every week via email to adapt the profile of recruited controls to the age, gender and geographic profiles of the cases that participated in the previous week;
  • cases will be offered to invite a person they live with to participate in the study offering another case-control analysis inside a household. Cases will be recommended not to invite the person that they suspect was responsible for their contamination, if a intra-household contamination is suspected. They will indicate the email address of that person to allow sending of an invitation via email. These participants will be required to report the result of the test as recommended by contact tracing guidelines to determine whether they are cases or controls.

Analysis will also include descriptive analysis:

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

入选标准

  • All participants:
  • Aged 18 years or more
  • Agreeing to participate in the study
  • Index cases:
  • Cases identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system)
  • Positive SARS-CoV-2 RT-PCR on nasopharyngeal or throat swab (or another sample which state of the art considers that it indicates an active infection if positive)
  • "Distant" controls:
  • Selected by Ipsos among Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis)
  • Health Care Workers
  • Close subjects:
  • People who live in the same household as a case and who have been invited to participate by that case
  • People who have had a RT-PCR test on nasopharyngeal or throat swab (or another sample which state of the art considers it indicates an active infection if positive) following diagnosis of the index case (following contact tracing recommendations), classified as:
  • close cases if test is positive
  • close controls if test is negative

排除标准

  • For all participants:
  • People under judicial protection measures ("sauvegarde de justice", "curatelle", "curatelle renforcée", "tutelle", ie various forms of curatorship under French law)
  • For related cases, related controls and "distant" controls:
  • People with a history of SARS-CoV-2 infection confirmed by RT-PCR or positive testing of anti-SARS-CoV-2 antibodies with serology (for related cases: before the current episode)

结局指标

主要结局

Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the online questionnaire

时间窗: 1 year

Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places through case-control analyses.

次要结局

  • Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the phone interview(1 year)
  • Odds-ratios of SARS-CoV-2 infection on socio-demographic factors, behaviors and practices and visited places reported by the participants in the phone interview(1 year)
  • Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the online questionnaire(1 year)
  • Level of adherence to mask-wearing reported in the phone interview(1 year)
  • Level of adherence to hand-washing in the phone interview(1 year)
  • Proportion of cases infected in family environment by SARS-CoV-2 reported by participants in the phone interview(1 year)
  • Proportion of cases infected in professional environment by SARS-CoV-2 reported by participants in the online questionnaire(1 year)
  • Level of adherence to mask-wearing reported in the online questionnaire(1 year)
  • Level of adherence to hand-washing in the online questionnaire(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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