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Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556318
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

Study Description
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Brief Summary:

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 Design
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Study Type : Observational
Actual Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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 and diagnostic findings [ Time Frame: Within 3 days ]

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
Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection
Criteria

Inclusion Criteria:

  • SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
  • Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
  • Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

Exclusion Criteria:

  • History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
  • Participation in another clinical 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): NCT04556318


Locations
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Germany
Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Technical University of Munich, Klinikum rechts der Isar
Munich, Germany
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
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Principal Investigator: Christoph Spinner, PD Dr. Technical University of Munich, Klinikum rechts der Isar
More Information
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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT04556318    
Other Study ID Numbers: HC-N-H-2004
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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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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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases