- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379297
COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE) (CON-VINCE)
February 15, 2023 updated by: Luxembourg Institute of Health
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
1870
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Strassen, Luxembourg, 1445
- Luxembourg Institute of Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Representative panel of the Luxembourgish population
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg
Time Frame: 04.2020-05.2021
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Evaluation of the prevalence by RT-PCR and serology testing
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04.2020-05.2021
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Collection of samples for research
Time Frame: 04.2020-05.2021
|
Samples will be analysed and stored for future research
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04.2020-05.2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psycho-social evaluation
Time Frame: 04.2020-05.2021
|
Psychological and socio- economic impact of long-term containment measures on the general population
|
04.2020-05.2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rejko Krüger, Dr, Luxembourg Institute of Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2020
Primary Completion (Actual)
June 10, 2021
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 6, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNER 202004/01
- 831x6ce0d (Other Identifier: Ministry of Health)
- FNR/CON-VINCE (Other Grant/Funding Number: Luxembourg National Research Fund)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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