Clinical trial NCT05336604: STUDY OF THE COVID-19 EPIDEMIC AND SOCIO-ECONOMIC LIVING CONDITIONS IN FRANCE
Official title: Epidémiologie et Conditions de Vide liées au Covid-19 STUDY OF THE COVID-19 (SARS-CoV-2) EPIDEMIC AND SOCIO-ECONOMIC LIVING
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Population
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, France
First posted: 2022-04-20
Enrollment: 134391
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in COVID-19 Seroprevalence over time
timeFrame: Inclusion, 6 months, 14 months, 28 months
measure: Changes in living condition
timeFrame: Inclusion, 6 months, 14 months, 28 months
measure: Changes in health condition
timeFrame: Inclusion, 6 months, 14 months, 28 months
measure: COVID-19 IgG antibodies median
timeFrame: 28 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Inserm U1018
Study officials:
References: