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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04602871
Recruitment Status : Completed
First Posted : October 26, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Scentech Medical Technologies Ltd

Study Description
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Brief Summary:
Early Detection of COVID-19 Using Breath Analysis -Feasibility Study.

Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Breath Biopsy Not Applicable

Detailed Description:
An interventional diagnostic prospective study study with risks and minimal constraints.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Feasibility Study
Actual Study Start Date : July 3, 2020
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Healthy subjects
COVID-19 Negative subjects
 Diagnostic Test: Breath Biopsy
Breath Biopsy sampling using the ReCIVA® Breath Sampler


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection. [ Time Frame: Through the study completion, up to 3 months. ]
    Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602871


Locations
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Israel
Soroka Medical Center
Be'er Sheva, Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Scentech Medical Technologies Ltd
Investigators
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Principal Investigator: David Shitrit, MD Meir Medical Center, Kfar Saba, Israel
More Information
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Responsible Party: Scentech Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT04602871    
Other Study ID Numbers: Cov-2-2020
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPDs are to be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases