Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)
Completed
- Conditions
- Covid19
- Registration Number
- NCT04556318
- Lead Sponsor
- B. Braun Melsungen AG
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 396
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SARS-CoV-2 related volatile organic compounds (VOC) 1 hour after breath gas sampling
- Secondary Outcome Measures
Name Time Method To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings Within 3 days
Trial Locations
- Locations (2)
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Technical University of Munich, Klinikum rechts der Isar
🇩🇪Munich, Germany