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Completed

NCT Number: NCT05224622

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

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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poriya Medical Center

Poria – Neve Oved, 1528001, 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 the investigator to distinguish between COVID-19 carriers and COVID-19 non-carriers 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 18 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 18 years old
  • Under guardianship or deprived of liberty
  • Pregnant or lactating woman

Treatment and study plan

VOX

Diagnostic Test

Breath exhalation into the mouthpiece of the VOX breath diagnostic device.

Primary outcomes

  1. Presence of Volatile Organic Compounds indicating carriers of COVID-19.

    Time frame: Through the study completion, up to 3 months.

    Obtain early verification accuracy of measures for a set of VOCs biomarkers indicating carriers of Corona virus.

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.

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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
May 31, 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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