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CompletedNCT04346264Updated May 4, 2022

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

An observational study in Virus Diseases and COVID-19, sponsored by Ludwig Boltzmann Institute for Lung Health. Completed at 1 site in Austria. Open to participants aged 6 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-05-04.

Sponsored by Ludwig Boltzmann Institute for Lung Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,419
Ages
6 Years to 85 Years
Sex
All
01

Study 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
  • 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.

02

Conditions studied

  • Virus Diseases
  • COVID-19
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 12,419 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ludwig Boltzmann Institute for Lung Health is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 85 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Eligibility criteria

Inclusion Criteria: all participants of the Austrian LEAD study will be invited (www.leadstudy.at) -

Exclusion Criteria: pregnancy, failure due to language

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,419 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • General Cohort

    Population general cohort from the Austrian LEAD Study

    Diagnostic Test: NO intervention planned due to the observational study design only a diagnostic testing

Interventions

  • Diagnostic testNO intervention planned due to the observational study design only a diagnostic testing

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

06

What researchers measure

Primary outcomes

  1. Prevalence of SARS-CoV-2 antibody titres

    Antibody Titres IgG and IgM

    Time frame: 5 weeks

Secondary outcomes

  1. Prevalence of SARS-CoV-2 antibody titres after 3 Months

    Re-Calculation including incidence of the general population

    Time frame: 4 Months

07

Study locations

1 site
  • The LEAD Study Center
    Vienna, 1140, Austria
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04346264
Lead sponsor
Ludwig Boltzmann Institute for Lung Health
Responsible party
Sponsor
First posted
Apr 15, 2020
Start date
Apr 27, 2020
Primary completion
May 27, 2020
Completion
May 27, 2020
Last update
May 4, 2022

Study contacts

Otto C Burghuber, Prof.MD
principal investigator · Ludwig Boltzmann Institute for Lung Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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