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Completed

NCT Number: NCT04602884

Early Detection of COVID-19 Using Breath Analysis

EARLY DETECTION OF COVID-19 USING BREATH ANALYSIS- FIRST CROSS-SECTIONAL 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–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDF COVID 19 Isolation Facility

Ashkelon, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Breath biopsy sampling using the ReCIVA Breath Sampler

Diagnostic Test

Breath biopsy sampling using the ReCIVA Breath Sampler

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

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: First Cross-Sectional Study

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Feb 7, 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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