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NCT04556318 Clinical Trial

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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04556318
Other study ID # HC-N-H-2004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 23, 2020
Est. completion date June 11, 2021

Study information
Verified date July 2021
Source B. Braun Melsungen AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 396
Est. completion date June 11, 2021
Est. primary completion date June 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
Germany Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin Berlin
Germany Technical University of Munich, Klinikum rechts der Isar Munich

Sponsors (1)
Lead Sponsor Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary SARS-CoV-2 related volatile organic compounds (VOC) 1 hour after breath gas sampling
Secondary To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings Within 3 days
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