Antibody Seroprevalence and Rate of Asymptomatic Infections With SARS-CoV-2 in Austrian Hospital Personnel.

NCT04354779 | Completed DMC

• 1 other identifier: AUVA SARS-CoV-2 Studie
• Study Type: observational
• Target: 3,301
• Locations: 1 country
• Sites: 1

Brief Summary

Context: On March 11, the World Health Organization (WHO) announced the current corona virus disease 2019 (COVID-19) outbreak as a pandemic. The first laboratory-confirmed case of COVID-19 in Austria was announced on February 27, 2020. Since then, the incidence of infection follows a gradual increase. Measurements taken by the Austrian government include travel restrictions, closing of national borders, social distancing, a mandatory use of facemasks in public, and closing of stores and restaurants. The underlying aim of those imposed restrictions is to contain the viral transmission and to slow spreading of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Objectives: The aims of this study are to determine i) how many employees in Austrian trauma hospitals and rehabilitation facilities have virus specific IgG and IgM antibodies against SARS-CoV-2, ii) how many are active virus carriers (symptomatic and asymptomatic), iii) how many employees are in their incubation period during the study period, and iv) to calculate the SARS-CoV-2 prevalence together with a specific occupation associated infection risk within the different specifications of health care workers. Study Design: Open uncontrolled observational cross-sectional study. Setting/Participants: A total of 4000 employees in 11 Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. Study Interventions and Measures: An antibody test for SARS-CoV-2 specific IgG and IgM antibodies, and a RT-PCR test based on oropharyngeal swab samples, as well as laboratory-based antibody tests using ELISA, will be implemented to ensure protection and preservation of health in hospital staff and are not part of the study. The tests will be conducted twice, with approximately two weeks in between testing. The results of the tests will be used for statistical analysis in this study together with a questionnaire including questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2; SARS-CoV 2; Coronavirus Infection; Covid19

Keywords

COVID-19 diagnostic testing; SARS-CoV 2; Severe Acute Respiratory Syndrome Coronavirus 2

Outcome Measures

Primary Outcomes (3)

• Antibody status in HCW

  To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.

  4 months

• Active virus carriers in HCW

  To determine how many are actively infected with or without showing symptoms.

  4 months

• Incubation time

  To determine how many employees are in their incubation period during study time.

  4 months

Secondary Outcomes (2)

• Background incidence rate

  4 months

• Occupation associated infection risk

  4 months

Study Arms (1)

AUVA HCW

health care workers in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA)

Diagnostic Test: a specifically designed self-administered questionnaire

Interventions

a specifically designed self-administered questionnaire DIAGNOSTIC_TEST

The questionnaire consists of the following items: questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.

AUVA HCW

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All employees in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) will be invited to participate in the study. In total, 4000 individuals in 12 hospitals and rehabilitation facilities in Austria will participate in the study.

You may qualify if:

• employees in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA)

Sponsors & Collaborators

• AUVA: lead
• Paracelsus Medical University: collaborator

Study Sites (1)

Allgemeine Unfallversicherungsanstalt

Vienna, 1200, Austria

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: May 11, 2020
• Primary Completion: August 23, 2020
• Study Completion: September 28, 2020
• Last Updated: September 30, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)