NCT04376996

Slovenian National COVID-19 Prevalence Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (actual)
• Sponsor: University of Ljubljana · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

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.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-20
• Primary completion: 2020-11-15
• Completion: 2020-12-15
• First posted: 2020-05-06
• Last updated: 2021-10-06

Locations

1 site across 1 country: Slovenia