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Early Detection of COVID-19 Using Breath Analysis (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: NCT04602884
Recruitment Status : Suspended (no additional parcipitants could be recruited at site.)
First Posted : October 26, 2020
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Scentech Medical Technologies Ltd

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

Condition or disease Intervention/treatment Phase
Covid19 Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 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: First Cross-Sectional Study
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: COVID-19 Positive patients
subjects who were found COVID-19 Positive according to swab test.
Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler
Breath biopsy sampling using the ReCIVA Breath Sampler

Healthy subjects
subjects who were found COVID-19 Negative according to swab test.
Diagnostic Test: Breath biopsy sampling using the ReCIVA Breath Sampler
Breath biopsy sampling using the ReCIVA Breath Sampler




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


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

  2. Correlation between the set of Volatile Organic Compounds found in breath biopsy and disease intensity. [ Time Frame: Through the study completion, up to 3 months. ]
    Correlation between the set of Volatile Organic Compounds found in breath biopsy and intensity of COVID-19 detected in a swab test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04602884


Locations
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Israel
IDF COVID 19 Isolation Facility
Ashkelon, Israel
Sponsors and Collaborators
Scentech Medical Technologies Ltd
Investigators
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Study Director: Natalie Dror, PhD Scentech Medical Technologies Ltd
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Responsible Party: Scentech Medical Technologies Ltd
ClinicalTrials.gov Identifier: NCT04602884    
Other Study ID Numbers: Cov-2-IDF
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 IPD is 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