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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 : Recruiting
First Posted : December 2, 2020
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
CeGaT GmbH
Information provided by (Responsible Party):
B. Braun Melsungen AG

Study Description
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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).


Condition or disease Intervention/treatment
SARS (Severe Acute Respiratory Syndrome) Covid19 Device: Ion Mobility Spectrometry (IMS)

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. SARS-CoV-2 related volatile organic compounds (VOC) [ Time Frame: 1 hour after breath gas sampling ]

Secondary Outcome Measures :
  1. To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019) [ Time Frame: within 1 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with suspected or diagnosed SARS-CoV-2 infection.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Study Manager 00495661 ext 710 studies@bbraun.com

Locations
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Germany
University Hospital Gießen and Marburg (UKGM), site Marburg Recruiting
Marburg, Germany
Contact: Juergen Schaefer, Prof. Dr.         
Principal Investigator: Juergen Schaefer, Prof. Dr.         
Sponsors and Collaborators
B. Braun Melsungen AG
CeGaT GmbH
Investigators
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Principal Investigator: Juergen Schaefer, Prof. Dr. University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)
More Information
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT04649931    
Other Study ID Numbers: HC-N-H-2006
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases