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.
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.
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.
- Conditions
- Virus Diseases, COVID-19
- 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 group | Role | What they receive |
|---|---|---|
| General Cohort | Population 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.
Prevalence of SARS-CoV-2 antibody titres
Antibody Titres IgG and IgM
Measured: 5 weeks
Secondary outcomes (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.
- First posted15 Apr 2020
- Study start27 Apr 2020
- Primary completion27 May 2020
- Study completion27 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virus DiseasesStudies 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
- Prospective
- Enrolment
- 12,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Lung Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Otto C Burghuber, Prof.MD, Principal investigator, Ludwig Boltzmann Institute for Lung Health
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoVid-19 - Infection and Antibody Formation in the Viennese Population - Data From the Vienna Health Study LEAD
- ClinicalTrials.gov ID
- NCT04346264
- Acronym / sponsor ID
- LEAD CoVid-19
- Conditions
- Virus Diseases, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,419 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Lung HealthUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 15 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.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Cohort | – | Diagnostic Test: NO intervention planned due to the observational study design only a diagnostic testingPopulation general cohort from the Austrian LEAD Study |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- General population cohort (The Austrian LEAD Study, NCT01727518), aged 6-85 years from Vienna, Austria
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NO intervention planned due to the observational study design only a diagnostic testingOnly a diagnostic test (serum blood and antibody measurement) is planned | Diagnostic test | General Cohort |
Primary outcome
Prevalence of SARS-CoV-2 antibody titres
Time frame: 5 weeks
Antibody Titres IgG and IgM
1 secondary outcome
Prevalence of SARS-CoV-2 antibody titres after 3 Months
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 4 May 2022.
- Results publication: PubMed 32255673Breyer-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.
- Homepage of the Austrian LEAD StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Otto C Burghuber, Prof.MD principal investigator
Ludwig Boltzmann Institute for Lung Health
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 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.