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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)

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ClinicalTrials.gov Identifier: NCT04649931
Recruitment Status : Completed
First Posted : December 2, 2020
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
CeGaT GmbH
Information provided by (Responsible Party):
B. Braun Melsungen AG

Tracking Information
First Submitted Date November 25, 2020
First Posted Date December 2, 2020
Last Update Posted Date May 3, 2021
Actual Study Start Date December 14, 2020
Actual Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2020)
SARS-CoV-2 related volatile organic compounds (VOC) [ Time Frame: 1 hour after breath gas sampling ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 25, 2020)
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 (Corona Virus Disease 2019) [ Time Frame: within 1 hour ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Differences in Exhaled Breath by Using Ion Mobility Spectrometry (IMS) in Subjects Tested for SARS-CoV-2 Infection (COVID-19 Disease)
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
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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients with suspected or diagnosed SARS-CoV-2 infection.
Condition
  • SARS (Severe Acute Respiratory Syndrome)
  • Covid19
Intervention Device: Ion Mobility Spectrometry (IMS)
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 26, 2021)
450
Original Estimated Enrollment
 (submitted: November 25, 2020)
400
Actual Study Completion Date April 25, 2021
Actual Primary Completion Date April 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04649931
Other Study ID Numbers HC-N-H-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party B. Braun Melsungen AG
Study 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)
PRS Account B. Braun Melsungen AG
Verification Date April 2021