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NCT04602884 Clinical Trial

Early Detection of COVID-19 Using Breath Analysis

Covid19 Clinical Trial

— COVID-19  

Official title:
Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis: First Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04602884
Other study ID # Cov-2-IDF
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2020
Est. completion date December 30, 2021

Study information
Verified date February 2022
Source Scentech Medical Technologies Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL STUDY

Description:

Primary objective- to identify and evaluate a set of biomarkers that represent both the genetic expression of the virus itself (SARS-CoV-2) and the metabolic activity of the immune system's response to the virus.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Age 18 to 55 years at the time of consent - Positive results for SARS-CoV-2 - Capable of understanding written and/or spoken language - Able to provide informed consent Exclusion Criteria: - Age under 18 years old - (Anticipated) inability to complete breath sampling procedure due to e.g. hyper- or hypoventilation, respiratory failure, or claustrophobia when wearing the sampling mask - Persons under guardianship or deprived of liberty - Patients with the following diseases: Cancer, Asthma, Chronic Respiratory Disease - Pregnant women - Treated with antiviral drugs upon admission or during hospitalization - Novices and soldiers in initial training

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Breath biopsy sampling using the ReCIVA Breath Sampler
Breath biopsy sampling using the ReCIVA Breath Sampler

Locations
Country Name City State
Israel IDF COVID 19 Isolation Facility Ashkelon

Sponsors (1)
Lead Sponsor Collaborator
Scentech Medical Technologies Ltd

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between Volatile Organic Compounds pattern and COVID-19 detection status. Correlation between the set of Volatile Organic Compounds found in breath biopsy and COVID-19 detection presence in a swab test. Through the study completion, up to 3 months.
Secondary Correlation between Volatile Organic Compounds pattern and time from COVID-19 detection. Correlation between the set of Volatile Organic Compounds found in breath biopsy and time since COVID-19 detected in a swab test. Through the study completion, up to 3 months.
Secondary Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity. Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test. Through the study completion, up to 3 months.
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