- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05336604
STUDY OF THE COVID-19 EPIDEMIC AND SOCIO-ECONOMIC LIVING CONDITIONS IN FRANCE (EpiCov)
Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Josiane Warszawski, MD, PhD
- Phone Number: 06 14 59 90 87 01 49 59 53 05
- Email: josiane.warszawski@inserm.fr
Study Contact Backup
- Name: Nathalie Bajos, PhD
- Phone Number: 06 66 32 30 00
- Email: nathalie.bajos@inserm.fr
Study Locations
-
-
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Le Kremlin-Bicêtre, France
- Recruiting
- Inserm U1018
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Contact:
- Josiane Warszawski, MD,PhD
- Phone Number: 330149595305
- Email: josiane.warszawski@inserm.fr
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Contact:
- Nathalie Bajos, PhD
- Email: nathalie.bajos@inserm.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- individuals aged 15 years or older
- living on January 1, 2020, in mainland France or one of three overseas departments (Martinique, Guadeloupe and Réunion Island).
Exclusion Criteria:
- individuals living in prisons at the time of the study
- people living in residential institutions for dependent elderly persons, as caregivers were not available during the epidemic period to help them with internet access or phone calls.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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General population, aged 15 years or more, living in France
Population-based ohort of general population, aged 15 years or more, living in France in May 2020, selected at random from national administrative sample frame
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in COVID-19 Seroprevalence over time
Time Frame: Inclusion, 6 months, 14 months, 28 months
|
Proportion of the individuals tested with an Euroimmun ELISA-S ratio >1.1 (ELISA S+), from home self-sampling on capillarous blood sampled. Serological tests was based on a capillarous blood samples collected by the participants themselves, at home, from a finger prick dried blood spot 903 Whatman paper (DBS) kits, which was subsequently analyzed in a centralized virology laboratory. The sample kits were delivered by express mail to each participant who had sent their samples by mail to the EpiCov biobank. At the biobank, DBS cards were punched from the spots on the Whatman paper, using a PantheraTM machine (PerkinElmer). The tubes were sent to the virology laboratory (Unité des virus Emergents, Inserm/IRD, Marseille, France), in order to detect IgG antibodies against the spike protein (Euroimmun ELISA-S), and neutralizing antibodies for non-negative ELISA-S. |
Inclusion, 6 months, 14 months, 28 months
|
Changes in living condition
Time Frame: Inclusion, 6 months, 14 months, 28 months
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Questions relating to living conditions were included: socioeconomic characteristics, size and nature of the habitation, number of people in the household, working condition, childcare, home-schooling, inter-partner relationships within the household
|
Inclusion, 6 months, 14 months, 28 months
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Changes in health condition
Time Frame: Inclusion, 6 months, 14 months, 28 months
|
Health status was described through general and specific questions regarding self-perceived health, symptoms potentially linked to COVID-19, mental health, and access to healthcare, whether or not linked to COVID-19.
|
Inclusion, 6 months, 14 months, 28 months
|
COVID-19 IgG antibodies median
Time Frame: 28 months
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Median of Euroimmun ELISA-S IgG, from home self-sampling on capillarous blood sampled.
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28 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C20-25
- 2020-A01191-38 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The EpiCov data is available for research purpose, 9 months after overall completion of one round. Access to anonymized individual data may be available before the planned period of open access : specific project has to be presented to the EpiCov exploitation committee : if accepted, it needs approval of ethics and reglementary Committee for researchers who meet the criteria for access to data.
The first round, and will be available by March 2022 concerning the second round for research purpose on CASD (https://www.casd.eu/), after submission to approval of French Ethics and Regulatory Committee procedure (Comité du Secret Statistique, CESREES and CNIL).
IPD Sharing Time Frame
IPD Sharing Access Criteria
Access for research purpose of first and second round on CASD (https://www.casd.eu/) is given after submission to approval of French Ethics and Regulatory Committee procedure (Comité du Secret Statistique, CESREES and CNIL).
Access to data for subsequent rounds may be available before the planned period of open access : specific project has to be presented to the EpiCov exploitation committee : if accepted, it needs approval of ethics and reglementary Committee for researchers who meet the criteria for access to data.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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