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

February 3, 2022 updated by: Scentech Medical Technologies Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ashkelon, Israel
        • IDF COVID 19 Isolation Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the study completion, up to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the study completion, up to 3 months.
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.
Through the study completion, up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scentech Medical Technologies Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 22, 2020

Primary Completion (ACTUAL)

December 30, 2021

Study Completion (ACTUAL)

December 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)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cov-2-IDF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD is 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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