Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
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|ClinicalTrials.gov Identifier: NCT04649931|
Recruitment Status : Completed
First Posted : December 2, 2020
Last Update Posted : May 3, 2021
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).
|Condition or disease||Intervention/treatment|
|SARS (Severe Acute Respiratory Syndrome) Covid19||Device: Ion Mobility Spectrometry (IMS)|
|Study Type :||Observational|
|Actual Enrollment :||450 participants|
|Official Title:||Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative|
|Actual Study Start Date :||December 14, 2020|
|Actual Primary Completion Date :||April 25, 2021|
|Actual Study Completion Date :||April 25, 2021|
- Device: Ion Mobility Spectrometry (IMS)
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.
- SARS-CoV-2 related volatile organic compounds (VOC) [ Time Frame: 1 hour after breath gas sampling ]
- To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019) [ Time Frame: within 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649931
|University Hospital Gießen and Marburg (UKGM), site Marburg|
|Principal Investigator:||Juergen Schaefer, Prof. Dr.||University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)|