STUDY OF THE COVID-19 EPIDEMIC AND SOCIO-ECONOMIC LIVING CONDITIONS IN FRANCE

NCT05336604 | Completed DMC

• 2 other identifiers: C20-252020-A01191-38
• Study Type: observational
• Target: 134,391
• Locations: 1 country
• Sites: 1

Brief Summary

EpiCov is a population-based cohort which aims to provide national and regional estimates of seroprevalence of SARS-CoV-2 infection and analyse relations between living conditions and the dynamics of the epidemic in France. The study population is a random sample of individuals aged 15 years and older, excluding people living in residences for the elderly and living in jail. The participants are recruited from the French national tax register and is representative of the population living in France. Home self-samples on Dried Blood Spots (DBS) for IgG and neutralizing antibodies detection were offered to a random national sub-sample of 12,114 in the 1st round of the EPICOV survey (May 2020) and to all respondents in the 2nd round (November 2020), including also serological testing for all members (≥ 6 years old) of household for 20% of index participants. A third round was perfomed in June-July 2021, without serological measurements. Overall, 134,391 participants have been enrolled in first-round (May 2020). Among them, 107 759 participated to the second round (November 2020) and 85 074 in third round (June 2021). The next wave is expected in March-april 2022.

Conditions

General Population

Outcome Measures

Primary Outcomes (4)

• Changes in COVID-19 Seroprevalence over time

  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

  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

• Changes in health condition

  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

  Median of Euroimmun ELISA-S IgG, from home self-sampling on capillarous blood sampled.

  28 months

Study Arms (1)

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population-based sample based on a national random probability sample from the administrative sample frame: all individuals aged 15 years or older on January 1, 2020, living in mainland France or one of three overseas departments (Martinique, Guadeloupe and Réunion Island). Due to the poor quality of the sampling frame, poor internet access and the use of multiple languages, two other overseas departments, French Guiana and Mayotte, were excluded from the study.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Inserm U1018

Le Kremlin-Bicêtre, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Home blood self-sample on dried blood spot (DBS) to perform COVID-19 serology Serological tests was based on a home self-capillarous blood samples collected by the participants, from a finger prick dried blood spot 903 Whatman paper (DBS) kits, subsequently analyzed in a centralized virology laboratory. At the biobank, DBS cards were punched 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.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 20, 2022
• Study Start: May 2, 2020
• Primary Completion: August 9, 2021
• Study Completion: May 4, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The first round is currently available and the second rond will be available by March 2022
• 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.

Locations

FR (1)