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

May 22, 2026 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nîmes, France, 30029
        • Recruiting
        • CHU de Nîmes
        • Contact:
        • Principal Investigator:
          • Paul LOUBET, MD, PhD
      • Nîmes, France
        • Not yet recruiting
        • Université de Nîmes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients likely to be affected by COVID-19
The study population consists of adult people who are likely to be affected by COVID-19 (symptomatic or close contacts) consulting for RT-PCR screening.
Device: eBAM Cov Testing
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 0
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
Day 0
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
Day 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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Collaborators

University of Nimes
brains' laboratory sas, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDIL/2022/VC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe