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

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).

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ion Mobility Spectrometry (IMS)

Device

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.

Primary outcomes

SARS-CoV-2 related volatile organic compounds (VOC)

Time frame: 1 hour after breath gas sampling

Secondary outcomes

To compare the SARS-CoV-2 specific VOC with the clinical symptoms of COVID-19 and diagnostic findings

Time frame: Within 3 days

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Sep 21, 2020
Registry last updated: Jul 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed