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

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).

Study Overview

• Status: Completed
• Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Device: Ion Mobility Spectrometry (IMS)

• Study Type: Observational
• Enrollment (Actual): 450

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany
    • University Hospital Gießen and Marburg (UKGM), site Marburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with suspected or diagnosed SARS-CoV-2 infection.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SARS-CoV-2 related volatile organic compounds (VOC)	1 hour after breath gas sampling

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Collaborators: CeGaT GmbH
• Investigators: Principal Investigator: Juergen Schaefer, Prof. Dr., University Hospital Marburg, Zentrum für unerkannte und seltene Erkrankungen (ZusE)

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): April 25, 2021
• Study Completion (Actual): April 25, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Severe Acute Respiratory Syndrome; COVID-19
• Other Study ID Numbers: HC-N-H-2006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No