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Clinical Trials/NCT04547114
NCT04547114
Unknown
Not Applicable

Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects

Klinikum Bayreuth GmbH1 site in 1 country200 target enrollmentSeptember 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV-2 Infection
Sponsor
Klinikum Bayreuth GmbH
Enrollment
200
Locations
1
Primary Endpoint
correct classification of SARS-CoV-2 infected and not infected subjects
Last Updated
5 years ago

Overview

Brief Summary

Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

Detailed Description

In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects. Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures. The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.

Registry
clinicaltrials.gov
Start Date
September 14, 2020
End Date
April 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • hospital admission staff members

Exclusion Criteria

  • too sick to comply with study procedures

Outcomes

Primary Outcomes

correct classification of SARS-CoV-2 infected and not infected subjects

Time Frame: 6 months

correct classification of SARS-CoV-2 infected and not infected subjects

Study Sites (1)

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