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

B. Braun Melsungen AG396 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

396

Conditions

Covid19

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

Technical University of Munich, Klinikum rechts der Isar

Munich, Germany

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.