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Completed

NCT Number: NCT04649931

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

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).

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Key information

Conditions

SARS (Severe Acute Respiratory Syndrome) COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Gießen and Marburg (UKGM), site Marburg

Marburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ion Mobility Spectrometry (IMS)

Device

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.

Primary outcomes

  1. SARS-CoV-2 related volatile organic compounds (VOC)

    Time frame: 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)

    Time frame: within 1 hour

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Collaborators

  • CeGaT GmbH

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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