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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04635592
Other study ID # KOAIT-1-2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 2020
Est. completion date January 31, 2021

Study information

Verified date November 2020
Source University Medical Centre Ljubljana
Contact Peter Poredos, MD, PhD
Phone +38615229455
Email peter.poredos@kclj.si
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date January 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana - active current employment at the department Exclusion Criteria: - current sick-leave

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
SARS-CoV2 nasal swab
SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies

Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (4)

Garcia-Basteiro AL, Moncunill G, Tortajada M, Vidal M, Guinovart C, Jiménez A, Santano R, Sanz S, Méndez S, Llupià A, Aguilar R, Alonso S, Barrios D, Carolis C, Cisteró P, Chóliz E, Cruz A, Fochs S, Jairoce C, Hecht J, Lamoglia M, Martínez MJ, Mitchell RA, Ortega N, Pey N, Puyol L, Ribes M, Rosell N, Sotomayor P, Torres S, Williams S, Barroso S, Vilella A, Muñoz J, Trilla A, Varela P, Mayor A, Dobaño 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. — View Citation

Gómez-Ochoa SA, Franco OH, Rojas LZ, Raguindin PF, Roa-Díaz ZM, Wyssmann BM, Guevara SLR, Echeverría LE, Glisic M, Muka T. COVID-19 in Healthcare Workers: A Living Systematic Review and Meta-analysis of Prevalence, Risk Factors, Clinical Characteristics, and Outcomes. Am J Epidemiol. 2020 Sep 1. pii: kwaa191. doi: 10.1093/aje/kwaa191. [Epub ahead of print] — View Citation

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. Review. — View Citation

Rudberg AS, Havervall S, Månberg A, Jernbom Falk A, Aguilera K, Ng H, Gabrielsson L, Salomonsson AC, Hanke L, Murrell B, McInerney G, Olofsson J, Andersson E, Hellström C, Bayati S, Bergström S, Pin E, Sjöberg R, Tegel H, Hedhammar M, Phillipson M, Nilsson P, Hober S, Thålin 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary positive nasal swab and serological test Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers 2 months
Secondary 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 8 months
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