NCT04346264

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,419

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2020

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

1 month

First QC Date

April 13, 2020

Last Update Submit

May 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of SARS-CoV-2 antibody titres

    Antibody Titres IgG and IgM

    5 weeks

Secondary Outcomes (1)

  • Prevalence of SARS-CoV-2 antibody titres after 3 Months

    4 Months

Study Arms (1)

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

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

General Cohort

Eligibility Criteria

Age6 Years - 85 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The LEAD Study Center

Vienna, 1140, Austria

Location

Related Publications (1)

  • 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.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Virus DiseasesCOVID-19

Condition Hierarchy (Ancestors)

InfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Otto C Burghuber, Prof.MD

    Ludwig Boltzmann Institute for Lung Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

April 27, 2020

Primary Completion

May 27, 2020

Study Completion

May 27, 2020

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations