Study of Socio-demographic Factors, Behaviors and Practices Associated With Infection With SARS-CoV-2 Responsible for COVID-19

NCT04607941 | Completed

• 2 other identifiers: 2020-0472020-A02560-39
• Study Type: observational
• Target: 766,818
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Covid19

Keywords

Covid19; behavior; epidemiology; questionnaires

Outcome Measures

Primary Outcomes (1)

• 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

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

  1 year

Secondary Outcomes (9)

• 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 family environment by SARS-CoV-2 reported by participants in the online questionnaire

  1 year

• Proportion of cases infected in professional 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 phone interview

  1 year

Study Arms (3)

Cases

Subjects diagnosed as positive for SARS-CoV-2 infection

Other: Questionnaires; Other: Phone interviews

Close Subjects

Subjects living within the same household as cases: * close cases if tested positive for SARS-CoV-2 following contact tracing recommendations * close controls if tested negative for SARS-CoV-2 following contact tracing recommendations

Other: Questionnaires; Other: Phone interviews

Control Subjects

Controls selected within the population to allow for an age, gender and location of residence-matched analysis with cases

Other: Questionnaires; Other: Phone interviews

Interventions

Questionnaires OTHER

Self-administered questionnaires

Cases; Close Subjects; Control Subjects

Phone interviews OTHER

A small amount of subjects will be selected at random for phone interviews.

Cases; Close Subjects; Control Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Index cases: People with positive SARS-CoV-2 test identified by the National Health Insurance (CNAM) in the nationwide database SIDEP (COVID-19 diagnosis information system), which is a system that collects data from tests performed in all testing facilities in France. Only people who have given their e-mail address to the CNAM will be contacted. Close subjects: Invited by index cases with whom they live. "Distant" controls: Selected by Ipsos' panel on age, gender and location of residence criteria (to allow for matched case-control analysis) and Health Care Workers.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut Pasteur: lead
• National Health Insurance Fund: collaborator
• IPSOS: collaborator
• Institut de Recherche en Santé Publique, France: collaborator
• Université de Nantes: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• iPLesp: collaborator

Study Sites (2)

Caisse Nationale d'Assurance Maladie

Paris, France

Location

IPSOS

Paris, France

Location

Related Publications (6)

• Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller J. Are psychological attitudes towards vaccination an expression of personality? A cross-sectional study on COVID-19 vaccination in France. BMC Public Health. 2025 Jan 17;25(1):209. doi: 10.1186/s12889-025-21364-9.

  PMID: 39825254 DERIVED

• Galmiche S, Charmet T, Rakover A, Cheny O, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 infection in professional settings, shops, shared transport, and leisure activities in France, 2020-2022. BMC Public Health. 2024 Sep 4;24(1):2411. doi: 10.1186/s12889-024-19651-y.

  PMID: 39232732 DERIVED

• Lievre G, Sicsic J, Galmiche S, Charmet T, Fontanet A, Mueller JE. Are the 7C psychological antecedents associated with COVID-19 vaccine behaviours beyond intentions? A cross-sectional study on at-least-one-dose and up-to-date vaccination status, and uptake speed among adults in France. Vaccine. 2024 May 22;42(14):3288-3299. doi: 10.1016/j.vaccine.2024.04.024. Epub 2024 Apr 19.

  PMID: 38643038 DERIVED

• Rakover A, Galmiche S, Charmet T, Cheny O, Omar F, David C, Martin S, Mailles A, Fontanet A. Source of SARS-CoV-2 infection: results from a series of 584,846 cases in France from October 2020 to August 2022. BMC Public Health. 2024 Jan 30;24(1):325. doi: 10.1186/s12889-024-17772-y.

  PMID: 38287286 DERIVED

• Galmiche S, Charmet T, Rakover A, Schaeffer L, Cheny O, von Platen C, Omar F, David C, Mailles A, Carrat F, Fontanet A. Risk of SARS-CoV-2 Infection Among Households With Children in France, 2020-2022. JAMA Netw Open. 2023 Sep 5;6(9):e2334084. doi: 10.1001/jamanetworkopen.2023.34084.

  PMID: 37713194 DERIVED

• Galmiche S, Charmet T, Madec Y, Rakover A, Schaeffer L, Cheny O, Omar F, Martin S, Mailles A, Carrat F, Fontanet A. Reduction of SARS-CoV-2 intra-household child-to-parent transmission associated with ventilation: results from a case-control study. BMC Public Health. 2023 Jun 26;23(1):1240. doi: 10.1186/s12889-023-16144-2.

  PMID: 37365557 DERIVED

MeSH Terms

Conditions

COVID-19; Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arnaud Fontanet, Pr

  Institut Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 29, 2020
• Study Start: October 27, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: April 6, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)