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

SARS-CoV 2 Clinical Trial

— SAPRIS-SERO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392388
• Other study ID #: C20-26
• Secondary ID: 2020-A01195-34
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: April 11, 2023

Study information

• Verified date: February 2024
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96883
• Est. completion date: April 11, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• non applicable, already enrolled in the cohorts

Exclusion Criteria:

• non applicable

Related Conditions & MeSH terms

• SARS-CoV 2

Intervention

Biological:
• Non applicable
to collect data from questionnaires and to collect serological samples

Locations

Country	Name	City	State
France	Inserm	Paris

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

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