Severe Acute Respiratory Syndrome Coronavirus 2NCT04354779
Antibody Seroprevalence and Rate of Asymptomatic Infections With SARS-CoV-2 in Austrian Hospital Personnel.
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 and SARS-CoV 2, run by AUVA at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV 2, Coronavirus Infection
- What is being tested?
- a specifically designed self-administered questionnaire
- How many people
- 3,301 participants
- Where
- 1 siteAustria
- Study dates
- 11 May 2020to 28 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- employees in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA)
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen
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.
Read more
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
- Being tested
- a specifically designed self-administered questionnaire
- Keywords
- COVID-19 diagnostic testing, SARS-CoV 2, Severe Acute Respiratory Syndrome Coronavirus 2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a specifically designed self-administered questionnaireDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AUVA HCW | health care workers in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) Receives: Diagnostic Test: a specifically designed self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Active virus carriers in HCW
To determine how many are actively infected with or without showing symptoms.
Measured: 4 months
Incubation time
To determine how many employees are in their incubation period during study time.
Measured: 4 months
Secondary outcomes (2)
Background incidence rate
To evaluate the "background incidence rate" of COVID-19 to calculate the SARS-CoV-2 prevalence in a defined cohort of the Austrian population.
Measured: 4 months
Occupation associated infection risk
To calculate a specific occupation associated infection risk within the different specifications of health care workers amongst AUVA employees.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start11 May 2020
- Primary completion23 Aug 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,301 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUVA
- Sponsor type
- University, hospital or other
- Collaborators
- Paracelsus Medical University
- Responsible party
- Principal investigator, Wolfgang Schaden, AUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354779
- Sponsor's protocol ID
- AUVA SARS-CoV-2 Studie
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2020
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be encrypted and anonymised.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antikörperseroprävalenz Und Hintergrundinfektionsrate Von SARS-CoV-2 in Einem österreichischen Schlüsselkollektiv an Arbeitnehmer*Innen
- ClinicalTrials.gov ID
- NCT04354779
- Acronym / sponsor ID
- AUVA SARS-CoV-2 Studie
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,301 participants (actual)
- Lead sponsor
- AUVAUniversity, hospital or other
- Collaborators
- Paracelsus Medical University
- Study start
- 11 May 2020 (actual)
- Primary completion
- 23 Aug 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUVA HCW | – | Diagnostic Test: a specifically designed self-administered questionnairehealth care workers in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA) |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- employees in Austrian trauma hospitals and rehabilitation facilities of the Austrian Social Insurance for Occupational Risks (AUVA)
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a specifically designed self-administered questionnaireThe questionnaire consists of the following items: questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities. | Diagnostic test | AUVA HCW |
Primary outcome
Antibody status in HCW
Time frame: 4 months
To determine how many employees in Austrian trauma hospitals and rehabilitation facilities have already virus specific IgG and IgM antibodies against SARS-CoV-2.
Active virus carriers in HCW
Time frame: 4 months
To determine how many are actively infected with or without showing symptoms.
Incubation time
Time frame: 4 months
To determine how many employees are in their incubation period during study time.
2 secondary outcomes
Background incidence rate
Time frame: 4 months
Occupation associated infection risk
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Individual participant dataSharing planned: No. IPD will be encrypted and anonymised.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome Coronavirus 2 and SARS-CoV 2, run by AUVA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody status in HCW (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.