Covid19
Conditions
Brief summary
Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air. In this feasibility study it is intended to find specific biomarker(s) in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
Interventions
Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.
Sponsors
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* SARS-CoV-2-Polymerase chain reaction (PCR) test result is available * Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection * Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR
Exclusion criteria
* History of SARS-CoV-2 outside the current respiratory episode (known from medical history) * Participation in another clinical study prior to breath analysis which could influence the result of the breath analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 related volatile organic compounds (VOC) | 1 hour after breath gas sampling |
Secondary
| Measure | Time frame |
|---|---|
| To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings | Within 3 days |
Countries
Germany
Outcome results
None listed