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

NCT ID: NCT04547114

Last Updated: 2020-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-14

Study Completion Date

2021-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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SARS-CoV-2 Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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SARS-CoV-2- infected

Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs

Multicapillary column coupled ion mobility spectrometry

Intervention Type DIAGNOSTIC_TEST

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

Multicapillary column coupled ion mobility spectrometry

Intervention Type DIAGNOSTIC_TEST

sampling of nasal air via a foam cuffed oxygen catheter

Interventions

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Multicapillary column coupled ion mobility spectrometry

sampling of nasal air via a foam cuffed oxygen catheter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

hospital admission staff members

Exclusion Criteria

too sick to comply with study procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Klinikum Bayreuth GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Bayreuth/ Bayreuth General Hospital

Bayreuth, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Thomas Bollinger, MD

Role: primary

+49921400755810

Claus Steppert, MD

Role: backup

+499214004902

Other Identifiers

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IMS COVID-19

Identifier Type: -

Identifier Source: org_study_id

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