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

COVID19 Clinical Trial

— CON-VINCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379297
• Other study ID #: CNER 202004/01
• Secondary ID: 831x6ce0dFNR/CON
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: Luxembourg Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1870
• Est. completion date: September 30, 2022
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19

Locations

Country	Name	City	State
Luxembourg	Luxembourg Institute of Health	Strassen

Sponsors (9)

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

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg	Evaluation of the prevalence by RT-PCR and serology testing	04.2020-05.2021
Primary	Collection of samples for research	Samples will be analysed and stored for future research	04.2020-05.2021
Secondary	Psycho-social evaluation	Psychological and socio- economic impact of long-term containment measures on the general population	04.2020-05.2021