Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

Covid19 Clinical Trial

— COVID-19  

Official title:

Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602871
• Other study ID #: Cov-2-2020
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: October 2020
• Source: Scentech Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Description:

An interventional diagnostic prospective study study with risks and minimal constraints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Hospitalized group:

• Age 18 to 75 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

• Was not treated with Anti-viral drugs

• Not a pregnant woman

Healthy group:

• Healthy volunteers

• Age 18 to 75 years at the time of consent

• No history of COVID-19

• Capable of understanding written and/or spoken language

• Able to provide informed consent

• Was not treated with Anti-viral drugs

• Not a pregnant woman

Sexes Eligible for Study: All

Exclusion Criteria:

Hospitalized group:

• 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

Healthy group:

• Age under 18 years old

• History of COVID-19

• Persons under guardianship or deprived of liberty

• Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Breath Biopsy
Breath Biopsy sampling using the ReCIVA® Breath Sampler

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva
Israel	Meir Medical Center	Kfar Saba

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 in-breath biopsy and COVID-19 detection.	Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.	Through the study completion, up to 3 months.
Secondary	Correlation between Volatile Organic Compounds pattern and the course of the disease	Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.	Through the study completion, up to 3 months.