SLO-COVID-19: Slovenian National COVID-19 Prevalence Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| General cohort General population cohort aged 0-100 years from Slovenia |
Diagnostic Test: NO intervention planned due to the observational study design - only a diagnostic testing
Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood
|
Outcome Measures
Primary Outcome Measures
- Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples [April to May 2020]
Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples
- Prevalence of anti-SARS-CoV-2 antibodies in blood samples [April to November 2020]
Prevalence of anti-SARS-CoV-2 antibodies in blood samples
Eligibility Criteria
Criteria
Inclusion Criteria:
Signed informed consent only.
Exclusion Criteria:
Declined participation, no response on study invitation, no samples collected.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Ljubljana | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University of Ljubljana
Investigators
- Principal Investigator: Mario Poljak, MD, Univesity of Ljubljana, Slovenia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ULMF2020-COVID-19