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Completed

NCT Number: NCT04602871

Early Detection of COVID-19 Using Breath Analysis - Feasibility Study

Early Detection of COVID-19 Using Breath Analysis -Feasibility 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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka Medical Center, Beersheba, Israel

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About this study

An interventional diagnostic prospective study study with risks and minimal constraints.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Hospitalized group:

  • Age 18 to 75 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
  • Was not treated with Anti-viral drugs
  • Not a pregnant woman

Healthy group:

  • Healthy volunteers
  • Age 18 to 75 years at the time of consent
  • No history of COVID-19
  • Capable of understanding written and/or spoken language
  • Able to provide informed consent
  • Was not treated with Anti-viral drugs
  • Not a pregnant woman

Sexes Eligible for Study: All

Exclusion criteria

Hospitalized group:

  • 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

Healthy group:

  • Age under 18 years old
  • History of COVID-19
  • Persons under guardianship or deprived of liberty
  • Subjects with the following diseases: Cancer, Asthma, Chronic Respiratory Disease

Treatment and study plan

Breath Biopsy

Diagnostic Test

Breath Biopsy sampling using the ReCIVA® Breath Sampler

Primary outcomes

  1. Correlation between Volatile Organic Compounds pattern in-breath biopsy and COVID-19 detection.

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

    Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection in a swab test.

Secondary outcomes

  1. Correlation between Volatile Organic Compounds pattern and the course of the disease

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

    Correlation between Volatile Organic Compounds found in breath biopsy chromatography and COVID-19 detection intensity in a swab test.

Sponsors and collaborators

Lead sponsor

Scentech Medical Technologies Ltd

Industry

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
May 10, 2022

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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