Study to Evaluate Whether Differences in Exhaled Breath Can be Identified Using Ion Mobility Spectrometry (IMS) in Subjects Tested Positive for SARS-CoV-2 Infection and Subjects Tested Negative

B. Braun Melsungen AG1 site in 1 country450 target enrollmentDecember 14, 2020

ConditionsSARS (Severe Acute Respiratory Syndrome)Covid19

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: SARS (Severe Acute Respiratory Syndrome)
Sponsor: B. Braun Melsungen AG
Enrollment: 450
Locations: 1
Primary Endpoint: SARS-CoV-2 related volatile organic compounds (VOC)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Breath gas analysis is the evaluation of exhaled breath. It aims to evaluate the volatile organic compounds (VOCs) in exhaled breath.

In this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).

Registry

clinicaltrials.gov

Start Date

December 14, 2020

End Date

April 25, 2021

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•PCR (= Polymerase Chain Reaction) testing for SARS CoV-2 will be/has been performed in a timely manner of sampling exhaled breath or PCR test for SARS-CoV-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and PCR test result is already available
•Subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands

Exclusion Criteria

•Previous (history) SARS-CoV-2 infection, independent of the current episode
•Participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis