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

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ClinicalTrials.gov Identifier: NCT04392388
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.

Condition or disease Intervention/treatment
SARS-CoV 2 Biological: Non applicable

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.

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Study Type : Observational
Estimated Enrollment : 110000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health, Perception, Practices, Relations and Social Inequalities in the General Population During the Covid-19 Crisis - Serology
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
serology samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants from cohorts entitled : Constances, E3N-E4N, ELFE, Epipage 2 and NutriNet-Santé
Criteria

Inclusion Criteria:

  • non applicable, already enrolled in the cohorts

Exclusion Criteria:

  • non applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392388


Contacts
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Contact: Fabrice Carrat +33 (0)1 44 73 84 44 fabrice.carrat@inserm.fr

Locations
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France
Inserm Recruiting
Paris, France
Contact: Fabrice Carrat         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Fabrice Carrat, MD Inserm - Sorbonne Université
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04392388    
Other Study ID Numbers: C20-26
2020-A01195-34 ( Other Identifier: ID RCB (ANSM) )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD sharing is managed via the cohorts (Constances, E3N/E4N, NutriNetSante, Elfe/Epipage2) specific governing bodies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
SARS-CoV2
cohort
containment
serology
prevention