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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448769
Recruitment Status : Completed
First Posted : June 26, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborators:
University of Lorraine
Métropole du Grand Nancy
Information provided by (Responsible Party):
Evelyne Schvoerer, Central Hospital, Nancy, France

Tracking Information
First Submitted Date  ICMJE June 23, 2020
First Posted Date  ICMJE June 26, 2020
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE June 26, 2020
Actual Primary Completion Date July 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2020)
  • 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.
  • 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).
  • 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.
  • 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
  • Proportion of infected households [ Time Frame: through study completion, an average of 4 hours ]
    To estimate the prevalence of infected households
  • 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
  • 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
  • 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.
  • 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.
  • • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19)
Official Title  ICMJE Epidemiological Study of Seroprevalence Against the SARS-CoV-2 Virus (COVID-19) in the Population of the Grand Nancy Metropolitan Area
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

Detailed Description

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. To date, these estimates are based on RT-qPCR tests carried out on individuals with symptoms of the disease, on people likely to present severe forms of COVID-19, known as 'vulnerable', or on the number of hospitalizations/deaths related to COVID-19. In order to refine these estimates, it is crucial to carry out measurements on a random sample of the population and to take biological samples for serological testing, in accordance with the recommendations of the HAS and the scientific societies.

Besides, it is important to assess the proportion of persons reporting that they have not developed symptoms of COVID-19 since the beginning of the epidemic among seropositive persons.

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 GNM population randomly selected.

It is a cross-sectional, not experimental study in the sense that it does not alter the exposure of participants; however, it does require a blood sample, which classifies it as minimal risk intervention research according to French law. The study is monocentric.

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.

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:

    • in one of the identified locations of the GNM after making an appointment with the dedicated secretariat.
    • at their homes for those vulnerable to Covid-19. The total duration of participation of a subject will be ½ day (collection of consent + filling in the questionnaire and blood sampling)

Data are collected from :

  • the electoral lists: surname, first names, gender, address allowing identification of the IRIS zone
  • self-report questionnaires (adapted to the age : an adult questionnaire, a child questionnaire completed by the parents and an adolescent questionnaire) : socio-demographic characteristics of the respondent : age, sex, professional activity, socio-professional category, level of education ; EPICES questionnaire (adult), FAS questionnaire (child) ; medical characteristics of the respondent : weight, height, smoking status, influenza vaccination, health problems, pregnancy; potential contacts with COVID-19: perception of having been infected by the coronavirus, close relatives having been infected; potential symptoms: exploration of symptoms felt since mid-February.
  • serological test results: Anti-SARS-CoV-2 IgT seropositivity

The statistical analysis concerns all participants who respond to the questionnaire (even if blood sample could not be collected); it does not include any intermediate results and there is no statistical criterion for stopping the research.

The following analyses will be carried out :

  • Proportions: All proportions (including seroprevalence) will have confidence intervals calculated with the approximation by the normal distribution when the observed proportion and the size of the study group allow it, otherwise by the exact calculation of the binomial distribution.
  • Risk groups: Standardized prevalences for age and sex and their confidence intervals will be given for each group of each risk factor (smoking status, weight status, level of insecurity). Significance (p-value) will be calculated by a chi-square test if the size of the subgroups allows it, a Fisher test otherwise. A relationship will be significant if p<0.05
  • 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.
  • Intra-household transmission: The share of infections due to intra-household transmission will be estimated using a Bayesian model.

    • - Symptom expression groups: In seropositive participants, an exploratory study will be conducted to determine whether there are typologies of symptom expression .

This type of survey should make it possible to estimate the penetration of the virus in a very geographically targeted population (GNM area) over a short period of time and to evaluate the role of households in the transmission of SARS-CoV-2.

This measurement, based on a random sample, could make it possible to consolidate estimates obtained from molecular biology data (qRT-PCR) or the number of hospitalizations and/or deaths.

In addition, in vitro neutralization tests will allow an initial assessment of the ability of the detected antibodies to protect against SARS-CoV-2.

Combined with other similar studies (COVAL Paris, Epicov, ...) it will make it possible to measure the heterogeneity of virus penetration at the national level and to consolidate symptom association profiles.

All of the results (detection of cases of infection, particularly those that have not experienced symptoms, estimation of the number of people protected against a new infection (neutralisation results)) will in turn feed into mathematical models of the SEIR type (Susceptible, Exposed, Infected, Recovered).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Coronavirus Infection
  • Prevalence
Intervention  ICMJE 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).
Study Arms  ICMJE 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.
Intervention: Biological: Anti-SARS-CoV-2 IgT seropositivity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2020)
2006
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2020)
2000
Actual Study Completion Date  ICMJE July 24, 2020
Actual Primary Completion Date July 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04448769
Other Study ID Numbers  ICMJE 2020PI128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Evelyne Schvoerer, Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE
  • University of Lorraine
  • Métropole du Grand Nancy
Investigators  ICMJE
Principal Investigator: Evelyne Schvoerer CHRU Nancy
PRS Account Central Hospital, Nancy, France
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP