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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04392388
Acronym
SAPRIS-SERO
Enrollment
96883
Registered
2020-05-18
Start date
2020-05-01
Completion date
2023-04-11
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV 2

Keywords

SARS-CoV2, cohort, containment, serology, prevention

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.

Interventions

BIOLOGICALNon applicable

to collect data from questionnaires and to collect serological samples

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* non applicable, already enrolled in the cohorts

Exclusion criteria

* non applicable

Design outcomes

Primary

MeasureTime frameDescription
Cumulative incidence of SARS-Cov2 infection in the general population.8 monthsSimple 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

MeasureTime frameDescription
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 infection8 monthsRate 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
Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants8 monthsProportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social déterminants during a time frame of 8 months.
Maintenance over time of the acquisition of anti-SARS-Cov2 antibodies8 monthsDecay kinetics estimated by mixed effect model with repeated data per subject
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 seroprevalence8 monthsProportion 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
Strengths of associations between socio-behavioral factors and level of seroprevalence8 monthsStrengths of associations between socio-behavioral factors and level of seroprevalence during a time frame of 8 months
Proportion of tests proposed, accepted, performed, based on social and demographic characteristics8 monthsProportion of tests proposed, accepted, performed, based on social and demographic characteristics during a time frame of 8 months.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026