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Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)

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ClinicalTrials.gov Identifier: NCT04556318
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

Tracking Information
First Submitted Date September 18, 2020
First Posted Date September 21, 2020
Last Update Posted Date July 8, 2021
Actual Study Start Date September 23, 2020
Actual Primary Completion Date June 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 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: September 18, 2020)
To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings [ Time Frame: Within 3 days ]
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 Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19)
Official Title Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2
Brief Summary

Breath analysis is the evaluation of exhaled air of humans. It aims to get information about the clinical status of a human being by monitoring its volatile organic compounds (VOCs) in exhaled air.

In this feasibility study it is intended to find specific biomarker(s) 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 Patients with signs or symptoms of any respiratory system infection or signs or symptoms indicating SARS-CoV-2 infection or radiological findings suggesting viral lung infection
Condition 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: July 7, 2021)
396
Original Estimated Enrollment
 (submitted: September 18, 2020)
100
Actual Study Completion Date June 11, 2021
Actual Primary Completion Date June 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
  • Signs or symptoms of any respiratory system infection or Signs or symptoms indicating SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
  • Breath test (Study intervention) must be performed within a 2 day time period after latest SARS-CoV-2 PCR

Exclusion Criteria:

  • History of SARS-CoV-2 outside the current respiratory episode (known from medical history)
  • Participation in another clinical 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 NCT04556318
Other Study ID Numbers HC-N-H-2004
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 Not Provided
Investigators
Principal Investigator: Christoph Spinner, PD Dr. Technical University of Munich, Klinikum rechts der Isar
PRS Account B. Braun Melsungen AG
Verification Date July 2021