COVID-19SLO-COVID-19NCT04376996
Slovenian National COVID-19 Prevalence Study
An observational study of COVID-19 and SARS-CoV-2, run by University of Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19, SARS-CoV-2
- How many people
- 3,000 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Apr 2020to 15 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 3,000 inhabitants randomly selected from the Slovenian general population. Sample is representative in age, gender, and geographical distribution.
Who may be able to join
- Signed informed consent only.
Who cannot join
- Declined participation, no response on study invitation, no samples collected.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- Being tested
- NO intervention planned due to the observational study design - only a diagnostic testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO intervention planned due to the observational study design - only a diagnostic testingDiagnostic test
Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood
| Study group | Role | What they receive |
|---|---|---|
| General cohort | General population cohort aged 0-100 years from Slovenia Receives: Diagnostic Test: NO intervention planned due to the observational study design - only a diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples
Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples
Measured: April to May 2020
Prevalence of anti-SARS-CoV-2 antibodies in blood samples
Prevalence of anti-SARS-CoV-2 antibodies in blood samples
Measured: April to November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start20 Apr 2020
- Primary completion15 Nov 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mario Poljak, MD, Principal investigator, Univesity of Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376996
- Sponsor's protocol ID
- ULMF2020-COVID-19
- Acronym
- SLO-COVID-19
- Status last verified
- Sep 2021
- First submitted
- 4 May 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32688068Poljak 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.
PubMed 33838303
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slovenian National COVID-19 Prevalence Study
- ClinicalTrials.gov ID
- NCT04376996
- Acronym / sponsor ID
- SLO-COVID-19 / ULMF2020-COVID-19
- Conditions
- COVID-19, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- University of LjubljanaUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General cohort | – | Diagnostic Test: NO intervention planned due to the observational study design - only a diagnostic testingGeneral population cohort aged 0-100 years from Slovenia |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 3,000 inhabitants randomly selected from the Slovenian general population. Sample is representative in age, gender, and geographical distribution.
Key inclusion criteria (1 listed)
- Signed informed consent only.
Key exclusion criteria (1 listed)
- Declined participation, no response on study invitation, no samples collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NO intervention planned due to the observational study design - only a diagnostic testingOnly a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood | Diagnostic test | General cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Results publication: PubMed 32688068Maver 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.
- Results publication: PubMed 33838303Poljak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Poljak, MD principal investigator
Univesity of Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2, run by University of Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SARS-CoV-2 RNA in nasopharyngeal samples (time frame: April to May 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376996, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.