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ID
Source
Brief title
Health condition
Sars-Cov-2-antibodies
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure of the study is the result of SARS-CoV-2 antibody testing (positive or negative), based on total IgG (dichotomous value).
Secondary outcome
The IgG titre (continuous value)
Background summary
Rationale: It is highly important to generate knowledge about the nature and determinants of the spread of SARS-CoV-2 in Limburg, a region severely affected by the COVID-19 pandemic. We hope to gain more insight into why Limburg has been severely affected by looking at possible risk exposure. The results of the study will, in addition to providing insight, contribute to the more targeted deployment of COVID-19 measures in 2020.
Objective: The primary objective of the study is to examine which determinants (risk exposure, symptoms, compliance with measures) are associated with a positive SARS-CoV-2 antibody test in inhabitants of the province of Limburg.
Study design: The study is a cross-sectional study with invasive measurements (blood-sampling by venepuncture).
Study population: Adult Limburgers (18 years and older) can participate in the study. The planned number of participants is 10.000.
Main study parameters/endpoints: The primary outcome measure of the study is the result of SARS-CoV-2 antibody testing (positive or negative), based on total IgG (dichotomous value). We study the association of a range of determinants with this outcome.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is low risk.
The questionnaire is non-invasive, it costs some time to fill in (about 35-40 minutes).
The venepuncture is a minimum burden. It is being conducted by well-trained and qualified staff, under the responsibility of the GGD. The risk therefore is very small. The participants receive the result of the corona-antibody test.
Study objective
Certain determinants (risk exposure, symptoms, compliance with measures) can be identified to be associated with a positive SARS-CoV-2 antibody test in inhabitants of 18 years and older of the province of Limburg
Study design
Cross-sectional (with option to be included in future follow-up measures)
Intervention
No interventions; observational study
Inclusion criteria
18 years and older and residence in Limburg, Nethetrlands
Exclusion criteria
younger than 18 years or no residence in Limburg
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8889 |
| Other | Approved Medical Ethical Committee of the University of Maastricht : METC 20-071 |