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

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ClinicalTrials.gov Identifier: NCT04379297
Recruitment Status : Active, not recruiting
First Posted : May 7, 2020
Last Update Posted : June 18, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Luxembourg Institute of Health

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
COVID19

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.

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Study Type : Observational
Estimated 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 : April 10, 2020
Actual Primary Completion Date : June 11, 2021
Estimated Study Completion Date : December 31, 2021



Primary Outcome Measures :
  1. Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg [ Time Frame: 04.2020-05.2021 ]
    Evaluation of the prevalence by RT-PCR and serology testing

  2. Collection of samples for research [ Time Frame: 04.2020-05.2021 ]
    Samples will be analysed and stored for future research


Secondary Outcome Measures :
  1. Psycho-social evaluation [ Time Frame: 04.2020-05.2021 ]
    Psychological and socio- economic impact of long-term containment measures on the general population


Biospecimen Retention:   Samples With DNA
Naso-pharyngeal swab, Oro-pharyngeal swab, Blood, sputum,Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Representative panel of the Luxembourgish population
Criteria

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

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): NCT04379297


Locations
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Luxembourg
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
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Principal Investigator: Rejko Krüger, Dr Luxembourg Institute of Health
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Responsible Party: Luxembourg Institute of Health
ClinicalTrials.gov Identifier: NCT04379297    
Other Study ID Numbers: CNER 202004/01
831x6ce0d ( Other Identifier: Ministry of Health )
FNR/CON-VINCE ( Other Grant/Funding Number: Luxembourg National Research Fund )
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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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 Luxembourg Institute of Health:
Coronavirus
COVID
Prevalence