Clinical trial NCT04635592: Serological Diagnostics of COVID-19 in Health Care Workers
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Keywords: SARS-CoV2 infection
Health care worker
Serology
Nasal swab tests
Anesthesiology and Intensive Care
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers at Department of Anesthesiology and Intensive Care at UMC Ljubljana

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* current sick-leave

Primary outcomes:
measure: positive nasal swab and serological test
timeFrame: 2 months
Secondary outcomes:
measure: Relation of positive SARS-CoV2 tests to risky contact history
timeFrame: 8 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of Anesthesiology and Intensive Care - Hear
name: Peter Poredos, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
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.
citation: 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.