Slovenian National COVID-19 Prevalence Study

NCT04376996 | Completed

• 1 other identifier: ULMF2020-COVID-19
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

NO intervention planned due to the observational study design - only a diagnostic testing DIAGNOSTIC_TEST

Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood

General cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3,000 inhabitants randomly selected from the Slovenian general population. Sample is representative in age, gender, and geographical distribution.

You may qualify if:

• Signed informed consent only.

You may not qualify if:

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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University of Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

• Maver Vodicar P, Ostrbenk Valencak A, Zupan B, Avsic Zupanc T, Kurdija S, Korva M, Petrovec M, Demsar J, Knap N, Strumbelj E, Vehovar V, Poljak M. Low prevalence of active COVID-19 in Slovenia: a nationwide population study of a probability-based sample. Clin Microbiol Infect. 2020 Nov;26(11):1514-1519. doi: 10.1016/j.cmi.2020.07.013. Epub 2020 Jul 18.

  PMID: 32688068 RESULT

• Poljak M, Ostrbenk Valencak A, Strumbelj E, Maver Vodicar P, Vehovar V, Resman Rus K, Korva M, Knap N, Seme K, Petrovec M, Zupan B, Demsar J, Kurdija S, Avsic Zupanc T. Seroprevalence of severe acute respiratory syndrome coronavirus 2 in Slovenia: results of two rounds of a nationwide population study on a probability-based sample, challenges and lessons learned. Clin Microbiol Infect. 2021 Jul;27(7):1039.e1-1039.e7. doi: 10.1016/j.cmi.2021.03.009. Epub 2021 Apr 7.

  PMID: 33838303 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and nasopharyngeal swab collected in Copan UTM media

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mario Poljak, MD

  Univesity of Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 6, 2020
• Study Start: April 20, 2020
• Primary Completion: November 15, 2020
• Study Completion: December 15, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)