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

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

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

Study Overview

• Status: Completed
• Conditions: Virus Diseases; COVID-19
• Intervention / Treatment: Diagnostic test: NO intervention planned due to the observational study design only a diagnostic testing

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.

• Study Type: Observational
• Enrollment (Actual): 12419

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1140
    • The LEAD Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 85 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Exclusion Criteria: pregnancy, failure due to language

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Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Only a diagnostic test (serum blood and antibody measurement) is planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of SARS-CoV-2 antibody titres	Antibody Titres IgG and IgM	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of SARS-CoV-2 antibody titres after 3 Months	Re-Calculation including incidence of the general population	4 Months

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Lung Health
• Investigators: Principal Investigator: Otto C Burghuber, Prof.MD, Ludwig Boltzmann Institute for Lung Health

Publications and helpful links

General 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.

Helpful Links

• Homepage of the Austrian LEAD Study

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 27, 2020
• Primary Completion (ACTUAL): May 27, 2020
• Study Completion (ACTUAL): May 27, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (ACTUAL): April 15, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Virus Diseases
• Other Study ID Numbers: LEAD CoVid-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No