Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04556318|
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : July 8, 2021
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).
|Condition or disease||Intervention/treatment|
|Covid19||Device: Ion Mobility Spectrometry (IMS)|
|Study Type :||Observational|
|Actual Enrollment :||396 participants|
|Official Title:||Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2|
|Actual Study Start Date :||September 23, 2020|
|Actual Primary Completion Date :||June 11, 2021|
|Actual Study Completion Date :||June 11, 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 and diagnostic findings [ Time Frame: Within 3 days ]
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): NCT04556318
|Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin|
|Technical University of Munich, Klinikum rechts der Isar|
|Principal Investigator:||Christoph Spinner, PD Dr.||Technical University of Munich, Klinikum rechts der Isar|