Slovenian National COVID-19 Prevalence Study

COVID-19 Clinical Trial

— SLO-COVID-19  

Official title:

Slovenian National COVID-19 Prevalence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376996
• Other study ID #: ULMF2020-COVID-19
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: September 2021
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 15, 2020
• Est. primary completion date: November 15, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Signed informed consent only.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

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

Locations

Country	Name	City	State
Slovenia	University of Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

Maver Vodicar P, Oštrbenk Valencak A, Zupan B, Avšic Županc T, Kurdija S, Korva M, Petrovec M, Demšar J, Knap N, Štrumbelj E, Vehovar V, Poljak M. Low prevalence of active COVID-19 in Slovenia: a nationwide population study of a probability-based sample. — View Citation

Poljak M, Oštrbenk Valencak A, Štrumbelj E, Maver Vodicar P, Vehovar V, Resman Rus K, Korva M, Knap N, Seme K, Petrovec M, Zupan B, Demšar J, Kurdija S, Avšic Županc T. Seroprevalence of severe acute respiratory syndrome coronavirus 2 in Slovenia: results — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples	Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples	April to May 2020
Primary	Prevalence of anti-SARS-CoV-2 antibodies in blood samples	Prevalence of anti-SARS-CoV-2 antibodies in blood samples	April to November 2020