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Virus DiseasesNCT04346264

CoVid-19 - Infection and Antibody Formation in the Viennese Population

An observational study of Virus Diseases and COVID-19, run by Ludwig Boltzmann Institute for Lung Health at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Summary of the study Study population: A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD) Potential output and analysis: Extent of age-specific infection and antibody formation Cumulative incidence of infection Rate of asymptomatic infection… Read more about this study

Who is it for?
Ages 6 to 85 years
Conditions the study is for
Virus Diseases, COVID-19
How many people
12,419 participants
Where
1 siteAustria
Study dates
27 Apr 2020to 27 May 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 6 to 85 years
  • All sexes
  • Child, Adult, Older adult

Study population: General population cohort (The Austrian LEAD Study, NCT01727518), aged 6-85 years from Vienna, Austria

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • The LEAD Study Center

    Vienna, 1140

Other trials in Austria

About this study

Official title: CoVid-19 - Infection and Antibody Formation in the Viennese Population - Data From the Vienna Health Study LEAD

Summary of the study

Study population:

Read more

A representative sample of the Viennese population stratified by age and gender (data from the Vienna Health Study LEAD)

Potential output and analysis:

  • Extent of age-specific infection and antibody formation
  • Cumulative incidence of infection
  • Rate of asymptomatic infection
  • Relationship with socioeconomics, lifestyle and risk factors (comorbidities)

Study design:

Prospective, longitudinal, stratified by age and gender

Duration of study:

Initial testing as soon as possible and repeat based on monitoring of the pandemic curve (probably after 2-3 months)

Information to be obtained from participants:

  • serum samples for information on SARS-CoV2 infection and antibody formation
  • data on clinical symptoms
Read the detailed description

Both international (WHO; (1) and national are calling for increased testing for the SARS-CoV-2 virus; at present it is completely unclear how many people will actually become infected with the Covid-19 virus or have formed antibodies against it during the pandemic. The greatest uncertainty of all calculation models on hospitalisation rates, morbidity and mortality of the pandemic is the unknown number of unreported cases of citizens infected or having been infected with Covid-19.

Currently the direct detection of the SARS-CoV-2 virus from the mouth/nose/throat swab using PCR is established worldwide with high sensitivity and specificity. This direct method is expensive and not always available in sufficient quantities. Furthermore, the results are strongly influenced by the quality of the smear collection.

The detection of antibodies against the SARS-CoV-2 virus is an alternative method for determining whether a person has been infected with SARS-CoV-2 and has developed an immune response to the virus. Recently several companies have been offering such kits for sale. According to national experts, these kits have not yet been sufficiently clinically validated, which is why valid data on their sensitivity and specificity are not yet available. However, on the validation of these tests are being worked hard all over the world, so that it can be assumed (the experts also agree on this) that data on the sensitivity and specificity of the antibody tests will be available in the foreseeable future.

Probably the only reasonable and feasible method of testing the actual rate of Covid-19 infection in a given population is to detect infection (either directly or indirectly by means of antibody testing) from a sample that is as representative as possible for this population.

The selected subjects of the LEAD study, the core project of the Ludwig Boltzmann Institute for Lung Health at Otto Wagner Hospital (the hospital association is an official partner of the institute), represent an exemplary representative sample of the general population in Vienna (i.e. the sample corresponds to the Viennese population in terms of age, gender, smoking habits, place of residence, etc.). In the LEAD study, more than 11,000 subjects (aged 6-80) mainly from Vienna were subjected to a "Health examination survey" (2).

Due to the conditions described above, blood should be drawn from the subjects of the LEAD study at two points in time (as early as possible and after two to three months) and blood sera should be frozen to determine antibodies against SARS-CoV-2 and tested with a test of high sensitivity and specificity. According to the WHO this procedure (longitudinal cohort study with serial sampling of the same individuals (in the same geographic area) each time) is recommended in that provides the most comprehensive information on extent of infection.

By testing for SARS-CoV-2 antibodies twice in the subjects of the LEAD study (random sample), an accurate and representative estimate of the actual positive Covid-19 cases in the Viennese population and the rate of spread during the pandemic could be extrapolated for Vienna in the foreseeable future. Since more than 1,500 individual parameters were measured in the participants of the LEAD study, conclusions on socioeconomics, lifestyle factors and possible risk profiles (e.g. co-morbidity, smoking behaviour, etc.) can be drawn from those who tested positive (but also negative). In addition, a query regarding symptoms should be carried out at both dates in order to obtain information on the percentage of asymptomatic infections with SARS-CoV-2.

Being tested
NO intervention planned due to the observational study design only a diagnostic testing
Medical subject headings
Virus Diseases, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NO intervention planned due to the observational study design only a diagnostic testingDiagnostic test

    Only a diagnostic test (serum blood and antibody measurement) is planned

Study groups in NCT04346264
Study groupRoleWhat they receive
General CohortPopulation general cohort from the Austrian LEAD Study
Receives: Diagnostic Test: NO intervention planned due to the observational study design only a diagnostic testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of SARS-CoV-2 antibody titres

    Antibody Titres IgG and IgM

    Measured: 5 weeks

Secondary outcomes (1)
  1. Prevalence of SARS-CoV-2 antibody titres after 3 Months

    Re-Calculation including incidence of the general population

    Measured: 4 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start27 Apr 2020
  3. Primary completion27 May 2020
  4. Study completion27 May 2020

Resources

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
Prospective
Enrolment
12,419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04346264
Sponsor's protocol ID
LEAD CoVid-19
Status last verified
May 2022
First submitted
13 Apr 2020
Last updated
4 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Breyer-Kohansal R, Faner R, Breyer MK, Ofenheimer A, Schrott A, Studnicka M, Wouters EFM, Burghuber OC, Hartl S, Agusti A. Factors Associated with Low Lung Function in Different Age Bins in the General Population. Am J Respir Crit Care Med. 2020 Jul 15;202(2):292-296. doi: 10.1164/rccm.202001-0172LE. No abstract available.

    PubMed 32255673

Questions about this trial

What is this clinical trial studying?

An observational study of Virus Diseases and COVID-19, run by Ludwig Boltzmann Institute for Lung Health 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 0 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 4 May 2022. 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?

Prevalence of SARS-CoV-2 antibody titres (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04346264, which also lists 1 linked publication.

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 4 May 2022.

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