Slovenian National COVID-19 Prevalence Study

Study Overview
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Brief Summary
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The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that were randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution. The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously. The investigators are using a direct detection of SARS-CoV-2 RNA in nasopharyngeal samples with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay.

Detailed Description
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The investigators are conducting a national COVID-19 prevalence survey on a sample of 3,000 inhabitants that we have randomly selected from the Slovenian population. The sample is representative in age, gender, and geographical distribution. The main objective is to assess how many people in Slovenia have COVID-19 in April/May 2020 and how many were infected with SARS-CoV-2 previously. Direct detection of SARS-CoV-2 RNA in nasopharyngeal samples is performed with validated two-target PCR-based commercial assay. For a serological response to the etiological agent, IgG and IgA anti-SARS-CoV-2 antibodies are measured in plasma samples using a validated commercial assay. Principal aims of the study are to systematically and accurately assess: How many people in Slovenia are actively infected with SARS CoV-2 in April/May 2020? How many are asymptomatic and do not even know they are or were infected? How many people in Slovenia have contacted SARS-CoV-2 and already have COVID-19 until mid May 2020? The study is carried out by the Institute of Microbiology and Immunology of University of Ljubljana. The Institute is Slovenia's leading institution for microbiology and immunology research. The study is joined by a team of IT specialists, data scientists, and statisticians from the other departments of the University of Ljubljana. To speed-up and support the study, an innovative information infrastructure for data gathering and management was purposely developed and optimized for the study. The system fosters error-free data collection, automatic processing of questionnaires using artificial intelligence approaches, and provides security for sensitive clinical data. All participants will be passively followed up twice monthly and tested again for the presence of anti-SARS-CoV-2 antibodies in plasma samples six months after enrollment.

Official Title
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Slovenian National COVID-19 Prevalence Study

Conditions
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COVID-19, SARS-CoV-2

Intervention / Treatment
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* Diagnostic Test: NO intervention planned due to the observational study design - only a diagnostic testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent only. Exclusion Criteria: Declined participation, no response on study invitation, no samples collected.
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General cohort<br>General population cohort aged 0-100 years from Slovenia | Diagnostic Test: NO intervention planned due to the observational study design - only a diagnostic testing<br>* Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples | Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples | April to May 2020 | 
| Prevalence of anti-SARS-CoV-2 antibodies in blood samples | Prevalence of anti-SARS-CoV-2 antibodies in blood samples | April to November 2020 |