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

• Sponsor: B. Braun Melsungen AG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04649931
• Collaborator: CeGaT GmbH (Other)
• Enrollment: 450
• Location: 1
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 103.8

Study Details

Study Description

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	Phase
SARS (Severe Acute Respiratory Syndrome); Covid19	Device: Ion Mobility Spectrometry (IMS)

Study Design

• Study Type: Observational
• Actual Enrollment: 450 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: Dec 14, 2020
• Actual Primary Completion Date: Apr 25, 2021
• Actual Study Completion Date: Apr 25, 2021

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 related volatile organic compounds (VOC) [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) [within 1 hour]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Gießen and Marburg (UKGM), site Marburg	Marburg		Germany

Sponsors and Collaborators

• B. Braun Melsungen AG
• CeGaT GmbH

Investigators

• Principal Investigator: Juergen Schaefer, Prof. Dr., University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: B. Braun Melsungen AG
• ClinicalTrials.gov Identifier: NCT04649931
• Other Study ID Numbers: HC-N-H-2006
• First Posted: Dec 2, 2020
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Severe Acute Respiratory Syndrome

Study Results

No Results Posted as of May 3, 2021