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

July 7, 2021 updated by: B. Braun Melsungen AG

Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

396

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
      • Munich, Germany
        • Technical University of Munich, Klinikum rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SARS-CoV-2 related volatile organic compounds (VOC)
Time Frame: 1 hour after breath gas sampling
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 and diagnostic findings
Time Frame: Within 3 days
Within 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Christoph Spinner, PD Dr., Technical University of Munich, Klinikum rechts der Isar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2020

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-N-H-2004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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