Clinical trial NCT04379297: COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)
Official title: COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Keywords: Coronavirus
COVID
Prevalence
Lead sponsor: Luxembourg Institute of Health
Sponsor class: OTHER_GOV
Collaborators: name: Luxembourg National Research Funds
name: University of Luxembourg
name: Centre Hospitalier du Luxembourg
name: TNS-Ilres
name: Laboratoires Réunis
name: BioneXt Lab
name: Ketterthill
name: Laboratoire National de santé
First posted: 2020-05-07
Enrollment: 1870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Representative panel of the Luxembourgish population

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg
timeFrame: 04.2020-05.2021
measure: Collection of samples for research
timeFrame: 04.2020-05.2021
Secondary outcomes:
measure: Psycho-social evaluation
timeFrame: 04.2020-05.2021
Other outcomes:
Locations:
city: Strassen
country: Luxembourg
facility: Luxembourg Institute of Health
Study officials:
affiliation: Luxembourg Institute of Health
name: Rejko Krüger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsurkalenko O, Bulaev D, O'Sullivan MP, Snoeck C, Ghosh S, Kolodkin A, Rommes B, Gawron P, Moreno CV, Gomes CPC, Kaysen A, Ohnmacht J, Schroder VE, Pavelka L, Meyers GR, Pauly L, Pauly C, Hanff AM, Meyrath M, Leist A, Sandt E, Aguayo GA, Perquin M, Gantenbein M, Abdelrahman T, Klucken J, Satagopam V, Hilger C, Turner J, Vaillant M, Fritz JV, Ollert M, Kruger R; CON-VINCE consortium and the ORCHESTRA working group. Creation of a pandemic memory by tracing COVID-19 infections and immunity in Luxembourg (CON-VINCE). BMC Infect Dis. 2024 Feb 9;24(1):179. doi: 10.1186/s12879-024-09055-z.
citation: Ribeiro F, Schroder VE, Kruger R, Leist AK; CON-VINCE Consortium. The evolution and social determinants of mental health during the first wave of the COVID-19 outbreak in Luxembourg. Psychiatry Res. 2021 Sep;303:114090. doi: 10.1016/j.psychres.2021.114090. Epub 2021 Jun 30.