NCT04635592

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 17, 2020

Last Update Submit

November 18, 2020

Conditions

SARS-CoV Infection

Keywords

SARS-CoV2 infectionHealth care workerSerologyNasal swab testsAnesthesiology and Intensive Care

Outcome Measures

Primary Outcomes (1)

  • positive nasal swab and serological test

    Rate of positive nasal swab and serological tests for SARS-CoV2 among health care workers

    2 months

Secondary Outcomes (1)

  • Relation of positive SARS-CoV2 tests to risky contact history

    8 months

Interventions

SARS-CoV2 nasal swabDIAGNOSTIC_TEST

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care workers at Department of Anesthesiology and Intensive Care at UMC Ljubljana

You may qualify if:

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

You may not qualify if:

  • current sick-leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (4)

  • 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.

    PMID: 32641730BACKGROUND

  • 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.

    PMID: 33033249BACKGROUND

  • 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.

    PMID: 32491919BACKGROUND

  • 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.

    PMID: 32870978BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

SARS-CoV2 nasal swabs Venous blood

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Peter Poredos, MD, PhD

    Department of Anesthesiology and Intensive Care - Hear

    STUDY CHAIR

Central Study Contacts

Peter Poredos, MD, PhD

CONTACT

+38615229455peter.poredos@kclj.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. prof.

Study Record Dates

First Submitted

November 17, 2020

First Posted

November 19, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)