SARS-CoV InfectionKORANITNCT04635592
Serological Diagnostics of COVID-19 in Health Care Workers
An observational study of SARS-CoV Infection, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV Infection
- What is being tested?
- SARS-CoV2 nasal swab
- How many people
- 300 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2020to 31 Jan 2021
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care workers at Department of Anesthesiology and Intensive Care at UMC Ljubljana
Who may be able to join
- employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana
- active current employment at the department
Who cannot join
- current sick-leave
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Ljubljana
Ljubljana, 1000
Peter Poredos, MD, PhD, +38615229455, peter.poredos@kclj.si
Marko Zlicar, MD, PhD, marko.zlicar@kclj.si
About this study
Official title: Serological Diagnostics of COVID-19 and Risk Factors for Infection Among Different Groups of Health Care Workers at Surgical Division at Tertiary Hospital
All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.
Read the detailed description
Health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana are working with COVID-19 patients in intensive care units, operating theaters, wards and emergency department. In the care of those patients different workgroups are involved: anesthesiologists, anesthesia and ICU nurses and respiratory therapeuts.There is insufficient data on the seroprevalence in different workgroups, different areas of the hospital, insufficient data on connection between SARS-CoV2 nasal swabs and antibodies and the rate of asymptomatic infections.
300 hundred HCW will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be filled.
- Conditions
- SARS-CoV Infection
- Being tested
- SARS-CoV2 nasal swab
- Keywords
- SARS-CoV2 infection, Health care worker, Serology, Nasal swab tests, Anesthesiology and Intensive Care
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV2 nasal swabDiagnostic test
SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies
What is being measured
The primary outcome is the main question the study is designed to answer.
positive nasal swab and serological test
Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers
Measured: 2 months
Secondary outcomes (1)
Relation of positive SARS-CoV2 tests to risky contact history
Relation of positive SARS-CoV2 tests to history of contacts with COVID-19 infected patients since the beginning of pandemia
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study startNov 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Poredos, University Medical Centre Ljubljana
- Investigators
- Peter Poredos, MD, PhD, Study chair, Department of Anesthesiology and Intensive Care - Hear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635592
- Sponsor's protocol ID
- KOAIT-1-2020
- Acronym
- KORANIT
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia-Basteiro AL, Moncunill G, Tortajada M, Vidal M, Guinovart C, Jimenez A, Santano R, Sanz S, Mendez S, Llupia A, Aguilar R, Alonso S, Barrios D, Carolis C, Cistero P, Choliz E, Cruz A, Fochs S, Jairoce C, Hecht J, Lamoglia M, Martinez MJ, Mitchell RA, Ortega N, Pey N, Puyol L, Ribes M, Rosell N, Sotomayor P, Torres S, Williams S, Barroso S, Vilella A, Munoz J, Trilla A, Varela P, Mayor A, Dobano C. Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital. Nat Commun. 2020 Jul 8;11(1):3500. doi: 10.1038/s41467-020-17318-x.
PubMed 32641730Rudberg AS, Havervall S, Manberg A, Jernbom Falk A, Aguilera K, Ng H, Gabrielsson L, Salomonsson AC, Hanke L, Murrell B, McInerney G, Olofsson J, Andersson E, Hellstrom C, Bayati S, Bergstrom S, Pin E, Sjoberg R, Tegel H, Hedhammar M, Phillipson M, Nilsson P, Hober S, Thalin C. SARS-CoV-2 exposure, symptoms and seroprevalence in healthcare workers in Sweden. Nat Commun. 2020 Oct 8;11(1):5064. doi: 10.1038/s41467-020-18848-0.
PubMed 33033249Oran DP, Topol EJ. Prevalence of Asymptomatic SARS-CoV-2 Infection : A Narrative Review. Ann Intern Med. 2020 Sep 1;173(5):362-367. doi: 10.7326/M20-3012. Epub 2020 Jun 3.
PubMed 32491919Gomez-Ochoa SA, Franco OH, Rojas LZ, Raguindin PF, Roa-Diaz ZM, Wyssmann BM, Guevara SLR, Echeverria LE, Glisic M, Muka T. COVID-19 in Health-Care Workers: A Living Systematic Review and Meta-Analysis of Prevalence, Risk Factors, Clinical Characteristics, and Outcomes. Am J Epidemiol. 2021 Jan 4;190(1):161-175. doi: 10.1093/aje/kwaa191.
PubMed 32870978
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological Diagnostics of COVID-19 and Risk Factors for Infection Among Different Groups of Health Care Workers at Surgical Division at Tertiary Hospital
- ClinicalTrials.gov ID
- NCT04635592
- Acronym / sponsor ID
- KORANIT / KOAIT-1-2020
- Conditions
- SARS-CoV Infection
- Keywords
- SARS-CoV2 infection, Health care worker, Serology, Nasal swab tests, Anesthesiology and Intensive Care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 19 Nov 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.
All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.
Detailed description
Health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana are working with COVID-19 patients in intensive care units, operating theaters, wards and emergency department. In the care of those patients different workgroups are involved: anesthesiologists, anesthesia and ICU nurses and respiratory therapeuts.There is insufficient data on the seroprevalence in different workgroups, different areas of the hospital, insufficient data on connection between SARS-CoV2 nasal swabs and antibodies and the rate of asymptomatic infections.
300 hundred HCW will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be filled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care workers at Department of Anesthesiology and Intensive Care at UMC Ljubljana
Key inclusion criteria (2 listed)
- employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana
- active current employment at the department
Key exclusion criteria (1 listed)
- current sick-leave
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 |
|---|---|---|
| SARS-CoV2 nasal swabSARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies | Diagnostic test | – |
Primary outcome
positive nasal swab and serological test
Time frame: 2 months
Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers
1 secondary outcome
Relation of positive SARS-CoV2 tests to risky contact history
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Background: PubMed 32641730Garcia-Basteiro AL, Moncunill G, Tortajada M, Vidal M, Guinovart C, Jimenez A, Santano R, Sanz S, Mendez S, Llupia A, Aguilar R, Alonso S, Barrios D, Carolis C, Cistero P, Choliz E, Cruz A, Fochs S, Jairoce C, Hecht J, Lamoglia M, Martinez MJ, Mitchell RA, Ortega N, Pey N, Puyol L, Ribes M, Rosell N, Sotomayor P, Torres S, Williams S, Barroso S, Vilella A, Munoz J, Trilla A, Varela P, Mayor A, Dobano C. Seroprevalence of antibodies against SARS-CoV-2 among health care workers in a large Spanish reference hospital. Nat Commun. 2020 Jul 8;11(1):3500. doi: 10.1038/s41467-020-17318-x.
- Background: PubMed 33033249Rudberg AS, Havervall S, Manberg A, Jernbom Falk A, Aguilera K, Ng H, Gabrielsson L, Salomonsson AC, Hanke L, Murrell B, McInerney G, Olofsson J, Andersson E, Hellstrom C, Bayati S, Bergstrom S, Pin E, Sjoberg R, Tegel H, Hedhammar M, Phillipson M, Nilsson P, Hober S, Thalin C. SARS-CoV-2 exposure, symptoms and seroprevalence in healthcare workers in Sweden. Nat Commun. 2020 Oct 8;11(1):5064. doi: 10.1038/s41467-020-18848-0.
- Background: PubMed 32491919Oran DP, Topol EJ. Prevalence of Asymptomatic SARS-CoV-2 Infection : A Narrative Review. Ann Intern Med. 2020 Sep 1;173(5):362-367. doi: 10.7326/M20-3012. Epub 2020 Jun 3.
- Background: PubMed 32870978Gomez-Ochoa SA, Franco OH, Rojas LZ, Raguindin PF, Roa-Diaz ZM, Wyssmann BM, Guevara SLR, Echeverria LE, Glisic M, Muka T. COVID-19 in Health-Care Workers: A Living Systematic Review and Meta-Analysis of Prevalence, Risk Factors, Clinical Characteristics, and Outcomes. Am J Epidemiol. 2021 Jan 4;190(1):161-175. doi: 10.1093/aje/kwaa191.
- 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.
Peter Poredos, MD, PhD study chair
Department of Anesthesiology and Intensive Care - Hear
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 SARS-CoV Infection, run by University Medical Centre 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 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Poredos, MD, PhD (+38615229455, peter.poredos@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive nasal swab and serological test (time frame: 2 months). 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 NCT04635592, which also lists 4 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 20 Nov 2020.