Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19)

NCT04448769 | Completed DMC

• 1 other identifier: 2020PI128
• Study Type: interventional
• Target: 2,006
• Locations: 1 country
• Sites: 1

Brief Summary

In order to inform the public decision on the containment strategy and knowledge of the intensity of the epidemic during post-containment, estimates of the share of the population infected with the SARS-CoV-2 virus responsible for COVID-19 disease at the territorial level are needed as soon as possible. The aim of the study is to estimate the prevalence of positive anti-SARS-CoV-2 serologies by detection of IgT-total antibodies (IgM/IgA/IgG) in the general population of the Grand Nancy Metropolitan area. A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected will be conducted. The target population consists of all the inhabitants of the Grand Nancy Metropolitan area, from which a sample is drawn from the electoral lists (households) in a random manner to ensure representativeness. In order to ultimately include 2000 people in the study

Conditions

Coronavirus Infection; Prevalence

Keywords

Epidemiology; General population

Outcome Measures

Primary Outcomes (1)

• Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity

  Anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area

  through study completion, an average of 4 hours

Secondary Outcomes (10)

• Proportion of asymptomatic, symptomatic cases among seropositive people

  through study completion, an average of 4 hours

• Proportion of asymptomatic cases among seropositive people

  through study completion, an average of 4 hours

• Identification of risk groups - Anti-SARS-CoV-2 IgT seropositivity by age, sex and as a function of weight status, smoking status, work activity and social status.

  through study completion, an average of 4 hours

• Proportion of seropositive subjects according to the level of social disadvantage measured by the EPICES score

  through study completion, an average of 4 hours

• Proportion of infected households

  through study completion, an average of 4 hours

Study Arms (1)

Anti-SARS-CoV-2 IgT seropositivity

OTHER

Analysis of the serology result: The ELISA method allows semi-quantitative detection of total IgT antibodies. A positive sample will be defined by a ratio ≥ 1.0.

Biological: Anti-SARS-CoV-2 IgT seropositivity

Interventions

Anti-SARS-CoV-2 IgT seropositivity BIOLOGICAL

Each inhabitant who agrees to participate will have to : * sign the consent form after receiving complete information * complete a questionnaire exploring sociodemographic (gender, age, professional activity...), medical (anthropometric measures, health problems, smoking...), potential contacts with COVID-19 and symptoms. * take a blood sample for the dermination of anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area (GNM).

Anti-SARS-CoV-2 IgT seropositivity

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Person who has received full information about the research organization and signed informed consent
• Person residing in the Grand Nancy Metropolitan area
• Person aged at least 5 years on 1 June 2020 and weighing more than 7 kg

You may not qualify if:

• Children under 5 years of age at the time of collection
• Person referred to in Articles L1121-8 of the Public Health Code. A person of full age who is subject to a legal protection measure (guardianship, curatorship, legal protection).
• Adult person unable to give consent
• \- Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• University of Lorraine: collaborator
• Métropole du Grand Nancy: collaborator

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Evelyne Schvoerer

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr

Model Details: A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 26, 2020
• Study Start: June 26, 2020
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)