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NCT04649931 Clinical Trial

Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04649931
Other study ID # HC-N-H-2006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2020
Est. completion date April 25, 2021

Study information
Verified date April 2021
Source B. Braun Melsungen AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date April 25, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

  • Covid19
  • SARS (Severe Acute Respiratory Syndrome)
  • Severe Acute Respiratory Syndrome

Intervention

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.

Locations
Country Name City State
Germany University Hospital Gießen and Marburg (UKGM), site Marburg Marburg

Sponsors (2)
Lead Sponsor Collaborator
B. Braun Melsungen AG CeGaT GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2 related volatile organic compounds (VOC) 1 hour after breath gas sampling
Secondary To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019) within 1 hour
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