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Completed

NCT Number: NCT04392388

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

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.

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Key information

Conditions

SARS-CoV 2

Sex eligibility

All sexes

Study type

Observational

Primary location

Inserm

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • non applicable, already enrolled in the cohorts

Exclusion criteria

  • non applicable

Treatment and study plan

Non applicable

Biological

to collect data from questionnaires and to collect serological samples

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: SAPRIS-SERO

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 18, 2020
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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