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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

96883

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants from cohorts entitled : Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé

Description

Inclusion Criteria:

  • non applicable, already enrolled in the cohorts

Exclusion Criteria:

  • non applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SAPRIS-SERO
SAPRIS-SERO enrolls participants from cohorts entitled: Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé.
to collect data from questionnaires and to collect serological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of SARS-Cov2 infection in the general population.
Time Frame: 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.
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabrice Carrat, MD, Inserm - Sorbonne Université

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

April 11, 2023

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • C20-26
  • 2020-A01195-34 (Other Identifier: ID RCB (ANSM))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD sharing is managed via the cohorts (Constances, E3N/E4N, NutriNetSante, Elfe/Epipage2) specific governing bodies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on SARS-CoV 2

Clinical Trials on Non applicable

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