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

B. Braun Melsungen AG2 sites in 1 country396 target enrollmentSeptember 23, 2020

ConditionsCovid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: B. Braun Melsungen AG
Enrollment: 396
Locations: 2
Primary Endpoint: SARS-CoV-2 related volatile organic compounds (VOC)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 23, 2020

End Date

June 11, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

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