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Serological Diagnostics of COVID-19 in Health Care Workers

NCT ID: NCT04635592

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2021-01-31

Brief Summary

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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

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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

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SARS-CoV Infection

Keywords

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SARS-CoV2 infection Health care worker Serology Nasal swab tests Anesthesiology and Intensive Care

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SARS-CoV2 nasal swab

SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana
* active current employment at the department

Exclusion Criteria

* current sick-leave
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Peter Poredos

Assist. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Poredos, MD, PhD

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care - Hear

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Central Contacts

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Peter Poredos, MD, PhD

Role: CONTACT

Phone: +38615229455

Email: [email protected]

Facility Contacts

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Peter Poredos, MD, PhD

Role: primary

Marko Zlicar, MD, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 32641730 (View on PubMed)

Rudberg 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.

Reference Type BACKGROUND
PMID: 33033249 (View on PubMed)

Oran 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.

Reference Type BACKGROUND
PMID: 32491919 (View on PubMed)

Gomez-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.

Reference Type BACKGROUND
PMID: 32870978 (View on PubMed)

Other Identifiers

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KOAIT-1-2020

Identifier Type: -

Identifier Source: org_study_id