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Slovenian National COVID-19 Prevalence Study

Slovenian National COVID-19 Prevalence Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04376996
Acronym
SLO-COVID-19
Enrollment
3000
Registered
2020-05-06
Start date
2020-04-20
Completion date
2020-12-15
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, SARS-CoV-2

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.

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.

Interventions

DIAGNOSTIC_TESTNO 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

Sponsors

University of Ljubljana
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

Signed informed consent only.

Exclusion criteria

Declined participation, no response on study invitation, no samples collected.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of SARS-CoV-2 RNA in nasopharyngeal samplesApril to May 2020Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples
Prevalence of anti-SARS-CoV-2 antibodies in blood samplesApril to November 2020Prevalence of anti-SARS-CoV-2 antibodies in blood samples

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026