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NCT Number: NCT06099795

Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2

During the COVID-19 pandemic, testing primarily relied on the use of nasopharyngeal swabs to detect the SARS-CoV-2 virus, responsible for the disease. However, this technique has several limitations, including the variable quality of swabs, its invasive nature, and arbitrariness in the choice of the number of cycles. Furthermore, it does not allow for the detection of viral proteins.

To overcome these limitations, researchers developed the eBAM-CoV test, patented for the detection of viral proteins in the exhaled air of COVID-19 patients. This portable device provides an immediate assessment of the "viral load" with both quantitative and qualitative results, showing promise for early virus detection.

The researchers hypothesize that the eBAM-CoV test is likely to exhibit a satisfactory concordance with the reference RT-PCR test in the detection of COVID-19, especially among symptomatic patients or closed contacts.

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Key information

Conditions

Sars-CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NIMES, Nîmes, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult male or female patients over 18 years of age (≥)
  • Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening.

Exclusion criteria

  • Inability to understand the procedures to use the device
  • Patient participating in an another interventional study
  • Patient in exclusion period determined by another study
  • Patient under court protection or guardianship
  • Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
  • Pregnant, parturient or breast-feeding patient

Treatment and study plan

eBAM Cov Testing

Device

Evaluation of presence/absence of infection with SARS-CoV-2 assessed by eBAM-CoV on air exhaled by the patient compared with the presence/absence of infection based on RT-PCR testing of nasopharyngeal swabs

Primary outcomes

  1. Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection

    Time frame: Day 0

    Evaluate the performance of the eBAM-CoV test by measuring the concordance between the eBAM-CoV method and the reference RT-PCR method (known as the "gold standard") in detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contacts).

Secondary outcomes

  1. diagnostic performance of the eBAM-CoV test

    Time frame: Day 0

    Preliminarily assess the diagnostic performance of the eBAM-CoV test by measuring the sensitivity/specificity between the eBAM-CoV method and the reference RT-PCR method (known as the "gold standard") for detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contact).

  2. concentration of SARS-CoV-2 viral proteins

    Time frame: Day 0

    Correlation between the concentration of SARS-CoV-2 viral proteins assessed by the eBAM-CoV test (eBAM-Unit) and the mean number of copies of mRNA encoding a protein fraction of SARS-CoV-2 viral proteins assessed using the RT-PCR technique

  3. Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR

    Time frame: Day 4

    Number of patients detected as positive by eBAM-CoV and negative by RT-PCR at Day 0 whose RT-PCR test becomes positive at Day 4

  4. Concordance between eBAM-CoV test and antigenic test

    Time frame: Day 0

    Concordance between the eBAM-CoV method and the antigenic test in patients likely to be infected with COVID-19 and volunteering for a second nasopharyngeal swab

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie COMPAN, PhD

CONTACT

[email protected]

+33664915140

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • University of Nimes
  • brains' laboratory sas, FRANCE

Registry information

Official study title

Evaluation of Concordance Between an Innovative Test on Exhaled Air (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 in Symptomatic Patients or Closed Contacts

Acronym: eBAM_CoV

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
May 27, 2026

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

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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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