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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Breath Biopsy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Soroka Medical Center
  • Kfar Saba, Israel
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COVID 19 Positive patients; Patients with COVID-19, qPCR for SARS-CoV-2 confirmed	Diagnostic test: Breath Biopsy; Breath Biopsy sampling using the ReCIVA® Breath Sampler
Other: Healthy subjects; COVID-19 Negative subjects	Diagnostic test: Breath Biopsy; Breath Biopsy sampling using the ReCIVA® Breath Sampler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Scentech Medical Technologies Ltd
• Investigators: Principal Investigator: David Shitrit, MD, Meir Medical Center, Kfar Saba, Israel

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Cov-2-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPDs are to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No