Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis

Completed

• Conditions: SARS-CoV 2
• Interventions: Biological: Non applicable

• Registration Number: NCT04392388
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Primary Completion: 2022-12-31
• Study Completion: 2023-04-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96883

Inclusion Criteria

• non applicable, already enrolled in the cohorts

Exclusion Criteria

• non applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAPRIS-SERO	Non applicable	SAPRIS-SERO enrolls participants from cohorts entitled: Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé.

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of SARS-Cov2 infection in the general population.	8 months	Simple and corrected estimate of the number of seropositive individuals/number of individuals at risk in different strata, based on weighting and calibration and taking into account the random cohort effect.

Secondary Outcome Measures

Name	Time	Method
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	8 months	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 during a time frame of 8 months
Strengths of associations between socio-behavioral factors and level of seroprevalence	8 months	Strengths of associations between socio-behavioral factors and level of seroprevalence during a time frame of 8 months
Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants	8 months	Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social déterminants during a time frame of 8 months.
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	8 months	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 during a time frame of 8 months
Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies	8 months	Decay kinetics estimated by mixed effect model with repeated data per subject
Proportion of tests proposed, accepted, performed, based on social and demographic characteristics	8 months	Proportion of tests proposed, accepted, performed, based on social and demographic characteristics during a time frame of 8 months.

Trial Locations

Locations (1)

Inserm; 🇫🇷 Paris, France