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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)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04649931
Enrollment
450
Registered
2020-12-02
Start date
2020-12-14
Completion date
2021-04-25
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS (Severe Acute Respiratory Syndrome)

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).

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.

Sponsors

CeGaT GmbH
CollaboratorUNKNOWN
B. Braun Melsungen AG
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
SARS-CoV-2 related volatile organic compounds (VOC)1 hour after breath gas sampling

Secondary

MeasureTime frame
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019)within 1 hour

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026