Slovenian National COVID-19 Prevalence Study

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed informed consent only.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples

Time frame: April to May 2020

Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples
Prevalence of anti-SARS-CoV-2 antibodies in blood samples

Time frame: April to November 2020

Prevalence of anti-SARS-CoV-2 antibodies in blood samples

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Acronym: SLO-COVID-19

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: May 6, 2020
Registry last updated: Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed