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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448769
Recruitment Status : Recruiting
First Posted : June 26, 2020
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
University of Lorraine
Métropole du Grand Nancy
Information provided by (Responsible Party):
Evelyne Schvoerer, Central Hospital, Nancy, France

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


Condition or disease Intervention/treatment Phase
Coronavirus Infection Prevalence Biological: Anti-SARS-CoV-2 IgT seropositivity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A study of seroprevalence and symptom collection, or absence of symptoms, on a cluster (household) sample of the Grand Nancy Metropolitan population randomly selected.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area
Actual Study Start Date : June 26, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

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Arm Intervention/treatment
Anti-SARS-CoV-2 IgT seropositivity
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

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).




Primary Outcome Measures :
  1. Anti-SARS-CoV-2 IgT (IgM/IgA/IgG) seropositivity [ Time Frame: through study completion, an average of 4 hours ]
    Anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area


Secondary Outcome Measures :
  1. Proportion of asymptomatic, symptomatic cases among seropositive people [ Time Frame: through study completion, an average of 4 hours ]
    To estimate the proportion of occurrence of an episode of clinical symptoms since the beginning of the epidemic among seropositive people using self report questionnaires.

  2. Proportion of asymptomatic cases among seropositive people [ Time Frame: through study completion, an average of 4 hours ]
    To estimate the proportion of asymptomatic cases (asymptomatic fraction) by the proportion of seropositive individuals who did not show any sign or symptom of COVID-19 since the beginning of the epidemic in France (mid-February).

  3. 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. [ Time Frame: through study completion, an average of 4 hours ]
    To understand susceptibility factors to infection by comparing infected and uninfected persons on the basis of age, sex, weight status, smoking status, occupation and education.

  4. Proportion of seropositive subjects according to the level of social disadvantage measured by the EPICES score [ Time Frame: through study completion, an average of 4 hours ]
    Determining the prevalence of seropositive people according to the level of social disadvantage

  5. Proportion of infected households [ Time Frame: through study completion, an average of 4 hours ]
    To estimate the prevalence of infected households

  6. Anti-SARS-CoV-2 IgT seropositivity in the household [ Time Frame: through study completion, an average of 4 hours ]
    To provide knowledge on intra-household dissemination

  7. Clinical expression patterns of infection by symptom/antibody association [ Time Frame: through study completion, an average of 4 hours ]
    To develop symptom association profiles in seropositive subjects

  8. Serological Response to Infection [ Time Frame: through study completion, an average of 4 hours ]
    To study the serum distribution of seropositive people, particularly in each symptom typology group.

  9. Anti-SARS-CoV-2 IgT seropositivity [ Time Frame: through study completion, an average of 4 hours ]
    To use the results of the SARS-CoV-2 seroprevalence testing campaign and questionnaires to refine our knowledge of the current and future situation and make better projections with better calibrated mathematical models of SIR infectious diseases.

  10. • Evaluation of serum neutralisation of persons positive for anti-SARS-CoV-2 antibodies, of the infectivity of viral strains in cell culture: percentage neutralisation compared to a viral strain not exposed to seropositive serum. [ Time Frame: through study completion, an average of 4 hours ]
    10. To evaluate the in vitro neutralisation capacity of the viral infectivity of the antibodies detected.



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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.


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): NCT04448769


Contacts
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Contact: Karine LEGRAND +33383859354 k.legrand@chru-nancy.fr
Contact: Marjorie STARCK +33385155273 m.starck@chru-nancy.fr

Locations
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France
Chru Nancy Recruiting
Vandœuvre-lès-Nancy, France, 54500
Contact: Evelyne SCHVOERER       e.schvoerer@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
University of Lorraine
Métropole du Grand Nancy
Investigators
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Principal Investigator: Evelyne Schvoerer CHRU Nancy
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Responsible Party: Evelyne Schvoerer, Pr, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04448769    
Other Study ID Numbers: 2020PI128
First Posted: June 26, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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 Evelyne Schvoerer, Central Hospital, Nancy, France:
Epidemiology
General population
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases