NCT04407429

Brief Summary

This study examines the seroprevalence against SARS-CoV-2 in health care workers and patients at the Vienna General Hospital.

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
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

First Submitted

Initial submission to the registry

May 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2021

Completed
Last Updated

May 29, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

May 27, 2020

Last Update Submit

May 27, 2020

Conditions

Keywords

COVID-19SARS-CoV-2ImmunityAntibodiesVirusRespiratory VirusImmunoglobulins

Outcome Measures

Primary Outcomes (1)

  • Prevalence of antibody status in healthcare workers and in patients admitted for non-COVID-19 related symptoms over time

    1 year

Secondary Outcomes (2)

  • Incidence rate of sero-conversion

    1 year

  • Identification of risk markers/factors for SARS-CoV-2 infection

    1 year

Study Arms (2)

Health care workers

Physicians, Nursing staff, Midwives, Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants), administrative personnel with patient contact

Diagnostic Test: Laboratory Analyses

Patients

Patients admitted for non-COVID related symptoms to the Vienna General Hospital with available residual serum samples.

Diagnostic Test: Laboratory Analyses

Interventions

Laboratory AnalysesDIAGNOSTIC_TEST

Storage of serum for SARS-CoV-2-antibodies and biomarkers

Health care workersPatients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort A: Health care workers Cohort B: Patients admitted for non-COVID related symptoms

You may qualify if:

  • Physicians
  • Nursing staff
  • Midwives
  • Medical-technical assistants (including medical, therapeutic and diagnostic healthcare staff, and medical and nursing assistants)
  • Administrative personnel with patient contact

You may not qualify if:

  • Not employed at the Medical University of Vienna or the Vienna General Hospital
  • No signed informed consent
  • Cohort B:
  • ● Patients with available residual serum samples
  • ● Serum samples from COVID-19 triage units at the Vienna General Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (1)

  • Riesenhuber M, Nitsche C, Binder CJ, Schernhammer ES, Stamm T, Jakse F, Anwari E, Hamidi F, Haslacher H, Perkmann T, Hengstenberg C, Zelniker TA. Comparison of the prevalence of SARS-CoV-2 nucleoprotein antibodies in healthcare workers and an unselected adult and paediatric all-comer patient population: insights from a longitudinal study of healthcare workers and concurrent serial cross-sectional studies of patients at an academic medical centre in Austria. BMJ Open. 2023 Jan 18;13(1):e063760. doi: 10.1136/bmjopen-2022-063760.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

COVID-19Virus Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Christian Hengstenberg, Univ.-Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Hengstenberg, Univ.-Prof.

CONTACT

Thomas A Zelniker, DDr.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof.

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

May 27, 2020

Primary Completion

June 27, 2021

Study Completion

June 27, 2021

Last Updated

May 29, 2020

Record last verified: 2020-05

Locations