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NCT04547114 Clinical Trial

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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04547114
Other study ID # IMS COVID-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 14, 2020
Est. completion date April 30, 2021

Study information
Verified date September 2020
Source Klinikum Bayreuth GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date April 30, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

hospital admission staff members

Exclusion Criteria:

too sick to comply with study procedures

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Multicapillary column coupled ion mobility spectrometry
sampling of nasal air via a foam cuffed oxygen catheter

Locations
Country Name City State
Germany Klinikum Bayreuth/ Bayreuth General Hospital Bayreuth

Sponsors (1)
Lead Sponsor Collaborator
Klinikum Bayreuth GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary correct classification of SARS-CoV-2 infected and not infected subjects correct classification of SARS-CoV-2 infected and not infected subjects 6 months
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