Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
Completed
- Conditions
- SARS (Severe Acute Respiratory Syndrome)Covid19
- Registration Number
- NCT04649931
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.
In this feasibility study it is intended to find specific peaks/pattern 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
- 450
Inclusion Criteria
- PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
- Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands
Exclusion Criteria
- Previous (history) SARS-CoV-2 infection, independent of the current episode
- Participation in a therapeutic 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 (Corona Virus Disease 2019) within 1 hour
Trial Locations
- Locations (1)
University Hospital Gießen and Marburg (UKGM), site Marburg
🇩🇪Marburg, Germany