Serological Diagnostics of COVID-19 in Health Care Workers

SARS-CoV Infection Clinical Trial

— KORANIT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04635592
• Other study ID #: KOAIT-1-2020
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronavirus Infections
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

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