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COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)

Sponsor
Luxembourg Institute of Health (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04379297
Collaborator
Luxembourg National Research Funds (Other), University of Luxembourg/ Luxembourg Centre for Systems Biomedicine (Other), Centre Hospitalier du Luxembourg (Other), TNS-Ilres (Other), Laboratoires Réunis (Other), BioneXt Lab (Other), Ketterthill (Other), Laboratoire National de santé (Other)
1,800
Enrollment
1
Location
29.7
Anticipated Duration (Months)
60.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CON-VINCE (COvid-19 National survey for assessing VIral spread by Non-affected CarriErs) is a national, monocentric, and longitudinal study aiming to evaluate the spread dynamics of the COVID-19 disease within the Luxembourgish population. Participants who are clinically asymptomatic or present with only mild symptoms will be followed up longitudinally, regularly tested for SARS-CoV-2 by RT-PCR, antibody status, and subjected to an epidemiological, clinical and biological phenotyping to better understand the nature, dynamics of infectivity and spread of the virus in the population. CON-VINCE will also track the psychological and socio-economic impact of long-term containment measures on the general population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To capture the dynamics and impact of the virus spread in the Luxembourgish population, data and sample collection is done every two weeks for two months (4 times in total) with a final follow-up one year after the participant's inclusion in the study. Participants complete questionnaires before each sample collection. The baseline questionnaire captures demographic data, medical history, behavioral and psychological data, and socio-economic status. Participants provided information on medical history, history of allergies, smoking, and chronic medication taken regularly. COVID-19-related data and environmental conditions of the household were obtained.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)
    Actual Study Start Date :
    Apr 10, 2020
    Actual Primary Completion Date :
    Jun 11, 2021
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg [04.2020-05.2021]

      Evaluation of the prevalence by RT-PCR and serology testing

    2. Collection of samples for research [04.2020-05.2021]

      Samples will be analysed and stored for future research

    Secondary Outcome Measures

    1. Psycho-social evaluation [04.2020-05.2021]

      Psychological and socio- economic impact of long-term containment measures on the general population

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects aged 18 and older of both genders, with a full capacity of consent.

    • SARS-CoV-2-positive individuals with an asymptomatic or oligosymptomatic infection (mild or oligosymptomatic disease course is defined as absence of fever and respiratory distress or cough not attributable to other known chronic disease).

    • OR SARS-CoV-2-negative individuals at the time of inclusion.

    • OR post-infectious SARS-CoV-2-negative individuals with acquired immunity to SARS-CoV-2 and a mild disease course.

    Exclusion Criteria:

    • Evolution of the COVID-19 disease requiring a hospital admission before inclusion in the study

    • Presence of fever and respiratory distress/cough at the time of inclusion not attributable to other known chronic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Luxembourg Institute of Health Strassen Luxembourg 1445

    Sponsors and Collaborators

    • Luxembourg Institute of Health
    • Luxembourg National Research Funds
    • University of Luxembourg/ Luxembourg Centre for Systems Biomedicine
    • Centre Hospitalier du Luxembourg
    • TNS-Ilres
    • Laboratoires Réunis
    • BioneXt Lab
    • Ketterthill
    • Laboratoire National de santé

    Investigators

    • Principal Investigator: Rejko Krüger, Dr, Luxembourg Institute of Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Luxembourg Institute of Health
    ClinicalTrials.gov Identifier:
    NCT04379297
    Other Study ID Numbers:
    • CNER 202004/01
    • 831x6ce0d
    • FNR/CON-VINCE
    First Posted:
    May 7, 2020
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Luxembourg Institute of Health
    Coronavirus
    COVID
    Prevalence
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Mar 23, 2022