- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04392388
Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis (SAPRIS-SERO)
December 3, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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
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
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Paris, France
- INSERM
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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.
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to collect data from questionnaires and to collect serological samples
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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.
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8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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8 months
|
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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
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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
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8 months
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Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social determinants
Time Frame: 8 months
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Proportion of infections without reported or pauci-symptomatic symptoms and their epidemiological and social déterminants during a time frame of 8 months.
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8 months
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Proportion of tests proposed, accepted, performed, based on social and demographic characteristics
Time Frame: 8 months
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Proportion of tests proposed, accepted, performed, based on social and demographic characteristics during a time frame of 8 months.
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8 months
|
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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
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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
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8 months
|
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Strengths of associations between socio-behavioral factors and level of seroprevalence
Time Frame: 8 months
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Strengths of associations between socio-behavioral factors and level of seroprevalence during a time frame of 8 months
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8 months
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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
- Robineau O, Zins M, Touvier M, Wiernik E, Lemogne C, de Lamballerie X, Blanche H, Deleuze JF, Saba Villarroel PM, Dorival C, Nicol J, Gomes-Rima R, Correia E, Coeuret-Pellicer M, Druesne-Pecollo N, Esseddik Y, Ribet C, Goldberg M, Severi G, Carrat F; Sante, Pratiques, Relations et Inegalites Sociales en Population Generale Pendant la Crise COVID-19-Serologie (SAPRIS-SERO) Study Group. Long-lasting Symptoms After an Acute COVID-19 Infection and Factors Associated With Their Resolution. JAMA Netw Open. 2022 Nov 1;5(11):e2240985. doi: 10.1001/jamanetworkopen.2022.40985.
- Carrat F, Villarroel PMS, Lapidus N, Fourie T, Blanche H, Dorival C, Nicol J, Deleuze JF, Robineau O; SAPRIS-SERO Study Group; Touvier M, Severi G, Zins M, de Lamballerie X. Heterogeneous SARS-CoV-2 humoral response after COVID-19 vaccination and/or infection in the general population. Sci Rep. 2022 May 21;12(1):8622. doi: 10.1038/s41598-022-11787-4.
- Robineau O, Wiernik E, Lemogne C, de Lamballerie X, Ninove L, Blanche H, Deleuze JF, Ribet C, Kab S, Goldberg M, Severi G, Touvier M, Zins M, Carrat F. Persistent symptoms after the first wave of COVID-19 in relation to SARS-CoV-2 serology and experience of acute symptoms: A nested survey in a population-based cohort. Lancet Reg Health Eur. 2022 Jun;17:100363. doi: 10.1016/j.lanepe.2022.100363. Epub 2022 Apr 12.
- Carrat F, Lapidus N, Ninove L, Blanche H, Rahib D, Saba Villarroel PM, Touvier M, Severi G, Zins M, Deleuze JF, de Lamballerie X; SAPRIS-SERO study group. Age, COVID-19-like symptoms and SARS-CoV-2 seropositivity profiles after the first wave of the pandemic in France. Infection. 2022 Feb;50(1):257-262. doi: 10.1007/s15010-021-01731-5. Epub 2021 Nov 25.
- Hoze N, Paireau J, Lapidus N, Tran Kiem C, Salje H, Severi G, Touvier M, Zins M, de Lamballerie X, Levy-Bruhl D, Carrat F, Cauchemez S. Monitoring the proportion of the population infected by SARS-CoV-2 using age-stratified hospitalisation and serological data: a modelling study. Lancet Public Health. 2021 Jun;6(6):e408-e415. doi: 10.1016/S2468-2667(21)00064-5. Epub 2021 Apr 8.
- Lapidus N, Paireau J, Levy-Bruhl D, de Lamballerie X, Severi G, Touvier M, Zins M, Cauchemez S, Carrat F; SAPRIS-SERO study group. Do not neglect SARS-CoV-2 hospitalization and fatality risks in the middle-aged adult population. Infect Dis Now. 2021 Jun;51(4):380-382. doi: 10.1016/j.idnow.2020.12.007. Epub 2021 Jan 18.
- Carrat F, de Lamballerie X, Rahib D, Blanche H, Lapidus N, Artaud F, Kab S, Renuy A, Szabo de Edelenyi F, Meyer L, Lydie N, Charles MA, Ancel PY, Jusot F, Rouquette A, Priet S, Saba Villarroel PM, Fourie T, Lusivika-Nzinga C, Nicol J, Legot S, Druesne-Pecollo N, Esseddik Y, Lai C, Gagliolo JM, Deleuze JF, Bajos N, Severi G, Touvier M, Zins M; for the SAPRIS and SAPRIS-SERO study groups. Antibody status and cumulative incidence of SARS-CoV-2 infection among adults in three regions of France following the first lockdown and associated risk factors: a multicohort study. Int J Epidemiol. 2021 Nov 10;50(5):1458-1472. doi: 10.1093/ije/dyab110.
- Glemain B, Assaad C, Ghosn W, Moulaire P, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F, Ancel PY, Charles MA, Severi G, Touvier M, Zins M, Kab S, Renuy A, Le-Got S, Ribet C, Pellicer M, Wiernik E, Goldberg M, Artaud F, Gerbouin-Rerolle P, Enguix M, Laplanche C, Gomes-Rima R, Hoang L, Correia E, Barry AA, Senina N, Allegre J, Szabo de Edelenyi F, Druesne-Pecollo N, Esseddik Y, Hercberg S, Deschasaux M, Charles MA, Benhammou V, Ritmi A, Marchand L, Zaros C, Lordmi E, Candea A, de Visme S, Simeon T, Thierry X, Geay B, Dufourg MN, Milcent K, Rahib D, Lydie N, Lusivika-Nzinga C, Pannetier G, Lapidus N, Goderel I, Dorival C, Nicol J, Robineau O, Lai C, Belhadji L, Esperou H, Couffin-Cadiergues S, Gagliolo JM, Blanche H, Sebaoun JM, Beaudoin JC, Gressin L, Morel V, Ouili O, Deleuze JF, Ninove L, Priet S, Villarroel PMS, Fourie T, Mohamed Ali S, Amroun A, Seston M, Ayhan N, Pastorino B, de Lamballerie X. Revisiting the link between COVID-19 incidence and infection fatality rate during the first pandemic wave. Sci Rep. 2025 May 5;15(1):15638. doi: 10.1038/s41598-025-99078-6.
- Pignon B, Wiernik E, Ranque B, Robineau O, Carrat F, Severi G, Touvier M, Gouraud C, Ouazana Vedrines C, Pitron V, Hoertel N, Kab S, Tebeka S, Goldberg M, Zins M, Lemogne C. SARS-CoV-2 infection and the risk of depressive symptoms: a retrospective longitudinal study from the population-based CONSTANCES cohort. Psychol Med. 2024 Oct 14;54(14):1-10. doi: 10.1017/S0033291724002435. Online ahead of print.
- Glemain B, de Lamballerie X, Zins M, Severi G, Touvier M, Deleuze JF; SAPRIS-SERO study group; Lapidus N, Carrat F. Estimating SARS-CoV-2 infection probabilities with serological data and a Bayesian mixture model. Sci Rep. 2024 Apr 25;14(1):9503. doi: 10.1038/s41598-024-60060-3.
- Charles MA, Ancel PY, Simeon T, Marchand-Martin L, Zaros C, Dufourg MN, Benhamou V, Blanche H, Deleuze JF, Rahib D, Lydie N, de Lamballerie X, Carrat F. SARS-CoV-2 seroprevalence in French 9-year-old children and their parents after the first lockdown in 2020. Front Pediatr. 2023 Oct 25;11:1274113. doi: 10.3389/fped.2023.1274113. eCollection 2023.
- Ramillon J, de Lamballerie X, Robineau O, Blanche H, Severi G, Touvier M, Zins M, Carrat F; SAPRIS-SERO study group; SAPRIS study group; Lapidus N. Correction: Antibody response, associated symptoms and profile of patients presumably infected by SARS-CoV-2 with taste or smell disorders in the SAPRIS multicohort study. BMC Infect Dis. 2023 Jul 26;23(1):492. doi: 10.1186/s12879-023-08450-2. No abstract available.
- Deschasaux-Tanguy M, Szabo de Edelenyi F, Druesne-Pecollo N, Esseddik Y, Allegre J, Srour B, Galan P, Hercberg S, Severi G, Zins M, Wiernik E; SAPRIS-SERO study group; de Lamballerie X, Carrat F, Touvier M. ABO blood types and SARS-CoV-2 infection assessed using seroprevalence data in a large population-based sample: the SAPRIS-SERO multi-cohort study. Sci Rep. 2023 Mar 23;13(1):4775. doi: 10.1038/s41598-023-30714-9.
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
Keywords
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.
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