COVID19CON-VINCENCT04379297
COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)
An observational study of COVID19, run by Luxembourg Institute of Health at 1 site in Luxembourg.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19
- How many people
- 1,870 participants
- Where
- 1 siteLuxembourg
- Study dates
- 10 Apr 2020to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Representative panel of the Luxembourgish population
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID19
- Keywords
- Coronavirus, COVID, Prevalence
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg
Evaluation of the prevalence by RT-PCR and serology testing
Measured: 04.2020-05.2021
Collection of samples for research
Samples will be analysed and stored for future research
Measured: 04.2020-05.2021
Secondary outcomes (1)
Psycho-social evaluation
Psychological and socio- economic impact of long-term containment measures on the general population
Measured: 04.2020-05.2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start10 Apr 2020
- Primary completion10 Jun 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Luxembourg National Research Fund, University of Luxembourg, Centre Hospitalier du Luxembourg, TNS-Ilres, Laboratoires Réunis, BioneXt Lab, Ketterthill, Laboratoire National de santé
- Responsible party
- Sponsor
- Investigators
- Rejko Krüger, Dr, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379297
- Sponsor's protocol ID
- CNER 202004/01
- Other IDs
- 831x6ce0d, FNR/CON-VINCE
- Acronym
- CON-VINCE
- Status last verified
- Aug 2024
- First submitted
- 6 May 2020
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsurkalenko O, Bulaev D, O'Sullivan MP, Snoeck C, Ghosh S, Kolodkin A, Rommes B, Gawron P, Rauschenberger A, 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.
PubMed 38336649Ribeiro 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.
PubMed 34247057
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COvid-19 National Survey for Assessing VIral Spread by Nonaffected CarriErs (CON-VINCE)
- ClinicalTrials.gov ID
- NCT04379297
- Acronym / sponsor ID
- CON-VINCE / CNER 202004/01
- Conditions
- COVID19
- Keywords
- Coronavirus, COVID, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,870 participants (actual)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Luxembourg National Research Fund, University of Luxembourg, Centre Hospitalier du Luxembourg, TNS-Ilres, Laboratoires Réunis, BioneXt Lab, Ketterthill, Laboratoire National de santé
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Representative panel of the Luxembourgish population
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Collection of samples for research
Time frame: 04.2020-05.2021
Samples will be analysed and stored for future research
1 secondary outcome
Psycho-social evaluation
Time frame: 04.2020-05.2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Results publication: PubMed 38336649Tsurkalenko O, Bulaev D, O'Sullivan MP, Snoeck C, Ghosh S, Kolodkin A, Rommes B, Gawron P, Rauschenberger A, 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.
- Results publication: PubMed 34247057Ribeiro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rejko Krüger, Dr principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and dynamics of the SARS-COV 2 infection in Luxemburg (time frame: 04.2020-05.2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.