Detection of COVID-19 Using Breath Analysis - Validation Study (COVID-19)

May 14, 2023 updated by: Scentech Medical Technologies Ltd

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

DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A diagnostic prospective single-site study, with no anticipated risks or constraints.

Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Study Type

Interventional

Enrollment (Actual)

2558

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
      • Be'er Ya'aqov, Israel
        • Shamir Medical Center

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

6 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 6 to 75 years at the time of consent
  • Capable of understanding written and/or spoken language
  • Able to provide informed consent
  • Was not treated with Anti-viral drugs

Exclusion Criteria:

  • Age under 6 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVID-19 patients
subjects who were found as COVID-19 positive patients by swab RT-PCR
Diagnostic test: Breath Biopsy Analysis
Analysis of a single breath Biopsy
Other: Healthy controls
subjects who were found as COVID-19 Negative, by swab RT-PCR
Diagnostic test: Breath Biopsy Analysis
Analysis of a single breath Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Time Frame: Through the study completion, up to 3 months.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
Through the study completion, up to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Time Frame: Through the study completion, up to 3 months.
Correlation level between exhaled biomarkers and participants' demographic characteristics.
Through the study completion, up to 3 months.
sensitivity level of biomarkers' algorithm.
Time Frame: Through the study completion, up to 3 months.
comparison of algorithm's sensitivity level to the sensitivity of COVID-19 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

Investigators

  • Study Director: Natalie Dror, PhD, 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)

November 12, 2020

Primary Completion (Actual)

May 28, 2022

Study Completion (Actual)

January 18, 2023

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 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cov-2-SMC-2020

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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