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Completed

NCT Number: NCT04602949

Detection of COVID-19 Using Breath Analysis - Validation Study

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shamir Medical Center

Be’er Ya‘aqov, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath Biopsy Analysis

Diagnostic Test

Analysis of a single breath Biopsy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Scentech Medical Technologies Ltd

Industry

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 26, 2020
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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