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NCT04341012 Clinical Trial

Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases

COVID19 Clinical Trial

Official title:
Development of a Breath Analysis Test for Disease Diagnosis and Prognosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04341012
Other study ID # 19-001971
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2019
Est. completion date September 3, 2021

Study information
Verified date March 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Description:

The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 3, 2021
Est. primary completion date September 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Able to provide informed consent Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Collection of breath sample
Analysis of volatile organic compounds in breath

Locations
Country Name City State
United States Mayo Clinic Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Breath volatile organic compound profiles Analysis of profiles of volatile organic compounds present in exhaled breath 1 day
Primary Utility of breath profiles for disease diagnosis or prognosis Diagnosis or prognostic utility of breath volatile organic compound profiles 14 days
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