- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04547114
Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Bayreuth, Germany, 95445
- Recruiting
- Klinikum Bayreuth/ Bayreuth General Hospital
-
Contact:
- Thomas Bollinger, MD
- Phone Number: +49921400755810
- Email: thomas.bollinger@klinikum-bayreuth.de
-
Contact:
- Claus Steppert, MD
- Phone Number: +499214004902
- Email: claus.steppert@klinikum-bayreuth.de
-
Principal Investigator:
- Thomas Bollinger, MD
-
Principal Investigator:
- Claus Steppert, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
hospital admission staff members
Exclusion Criteria:
too sick to comply with study procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SARS-CoV-2- infected
Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs
|
sampling of nasal air via a foam cuffed oxygen catheter
|
non infected
Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs
|
sampling of nasal air via a foam cuffed oxygen catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMS COVID-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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