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

General Population Clinical Trial

— EpiCov  

Official title:

Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336604
• Other study ID #: C20-25
• Secondary ID: 2020-A01191-38
• Status: Recruiting
• Start date: May 2, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2022
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Josiane Warszawski, MD, PhD
• Phone: 01 49 59 53 05
• Email: josiane.warszawski[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134391
• Est. completion date: August 30, 2022
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• General Population

Locations

Country	Name	City	State
France	Inserm U1018	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	COVID-19 IgG antibodies median	Median of Euroimmun ELISA-S IgG, from home self-sampling on capillarous blood sampled.	28 months