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

• Conditions: SARS-CoV-2 Infection

• Registration Number: NCT04547114
• Lead Sponsor: Klinikum Bayreuth GmbH

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Study Start: 2020-09-14
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

hospital admission staff members

Exclusion Criteria

too sick to comply with study procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correct classification of SARS-CoV-2 infected and not infected subjects	6 months	correct classification of SARS-CoV-2 infected and not infected subjects

Trial Locations

Locations (1)

Klinikum Bayreuth/ Bayreuth General Hospital; 🇩🇪 Bayreuth, Germany