Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
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
1 other identifier
observational
450
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 2, 2020
CompletedStudy Start
First participant enrolled
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2021
CompletedMay 3, 2021
April 1, 2021
4 months
November 25, 2020
April 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
SARS-CoV-2 related volatile organic compounds (VOC)
1 hour after breath gas sampling
Secondary Outcomes (1)
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)
within 1 hour
Interventions
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.
Eligibility Criteria
Adult patients with suspected or diagnosed SARS-CoV-2 infection.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- B. Braun Melsungen AGlead
- CeGaT GmbHcollaborator
Study Sites (1)
University Hospital Gießen and Marburg (UKGM), site Marburg
Marburg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juergen Schaefer, Prof. Dr.
University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 2, 2020
Study Start
December 14, 2020
Primary Completion
April 25, 2021
Study Completion
April 25, 2021
Last Updated
May 3, 2021
Record last verified: 2021-04