Clinical trial NCT04392388: Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis
Official title: Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis - Serology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
Keywords: SARS-CoV2
cohort
containment
serology
prevention
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2020-05-18
Enrollment: 96883
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from cohorts entitled : Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé

Brief summary: This study aims to quantify and follow the cumulative incidence of SARS-CoV-2 infection in the French population using serological tests and to assess the determinants of infection from Constances, E3N-E4N, ELFE-Epipage 2 and NutriNet-Santé cohorts.

Detailed description: The primary objective is to assess the cumulative incidence of infection in the general population using dried blood spot sampling.

The secondary objectives are:

* To identify factors associated with a positive SARS-CoV-2 infection (positive serology) and to characterize the durability of the serological response to SARS-CoV-2
* To identify associations of symptoms predictive of a SARS-CoV-2 infection
* To estimate the health care use associated with a SARS-CoV-2 infection
* To estimate the fraction of sub-clinical infections or infections not captured by the healthcare system;
* To study the acceptability of a mass anti-SARS-CoV-2 serological testing and the impact of its result, linked with social inequalities in health;
* To estimate the individual and collective impact of containment and other preventive measures on the risk of SARS-CoV-2 infection;
* To study the impact of social and territorial inequalities on seroprevalence levels.

Eligibility criteria: Inclusion Criteria:

* non applicable, already enrolled in the cohorts

Exclusion Criteria:

* non applicable

Primary outcomes:
measure: Cumulative incidence of SARS-Cov2 infection in the general population.
timeFrame: 8 months
Secondary outcomes:
measure: Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies
timeFrame: 8 months
measure: Rate of use of care (medical care, hospitalization, center 15) linked to the occurrence of symptoms suggestive of a SARS-Cov2 infection, and share attributable to the infection
timeFrame: 8 months
measure: Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants
timeFrame: 8 months
measure: Proportion of tests proposed, accepted, performed, based on social and demographic characteristics
timeFrame: 8 months
measure: Proportion and intensity of use of barrier measures (hydroalcoholic gel, mask, social distancing, description of outings / reasons, duration, frequency) and association with the level of seroprevalence
timeFrame: 8 months
measure: Strengths of associations between socio-behavioral factors and level of seroprevalence
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Inserm
Study officials:
affiliation: Inserm - Sorbonne Université
name: Fabrice Carrat, MD
role: PRINCIPAL_INVESTIGATOR
References: