SARS-CoV-2 InfectioneBAM_CoVNCT06099795
Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
A study testing eBAM Cov Testing in people with SARS-CoV-2 Infection and COVID-19, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, COVID-19, Coronavirus
- What is being tested?
- eBAM Cov Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de NIMES
Nîmes, 30029
Paul LOUBET, MD, PhD, +33466684149, paul.loubet@chu-nimes.fr
Paul LOUBET, MD, PhD
- Not yet recruiting
Université de Nîmes
Nîmes
Fanny GRAU COPPIETERS, Dr, 33 ext. 04.66.36.46.46, fanny.grau@unimes.fr
About this study
Official 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
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.
- Conditions
- SARS-CoV-2 Infection, COVID-19, Coronavirus
- Being tested
- eBAM Cov Testing
- Keywords
- Diagnostic Test Kits
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eBAM Cov TestingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Patients likely to be affected by COVID-19 | Experimental | 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. Receives: Device: eBAM Cov Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection
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).
Measured: Day 0
Secondary outcomes (4)
diagnostic performance of the eBAM-CoV test
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).
Measured: Day 0
concentration of SARS-CoV-2 viral proteins
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
Measured: Day 0
Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR
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
Measured: Day 4
Concordance between eBAM-CoV test and antigenic test
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jan 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nimes, brains' laboratory sas, FRANCE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099795
- Sponsor's protocol ID
- IDIL/2022/VC-01
- Acronym
- eBAM_CoV
- Status last verified
- May 2026
- First submitted
- 18 Oct 2023
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06099795
- Acronym / sponsor ID
- eBAM_CoV / IDIL/2022/VC-01
- Conditions
- SARS-CoV-2 Infection, COVID-19, Coronavirus
- Keywords
- Diagnostic Test Kits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- University of Nimes, brains' laboratory sas, FRANCE
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients likely to be affected by COVID-19 | Experimental | Device: eBAM Cov TestingThe study population consists of adult people who are likely to be affected by COVID-19 (symptomatic or close contacts) consulting for RT-PCR screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eBAM Cov TestingEvaluation 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 | Device | Patients likely to be affected by COVID-19 |
Primary outcome
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).
4 secondary outcomes
diagnostic performance of the eBAM-CoV test
Time frame: Day 0
concentration of SARS-CoV-2 viral proteins
Time frame: Day 0
Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR
Time frame: Day 4
Concordance between eBAM-CoV test and antigenic test
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eBAM Cov Testing in people with SARS-CoV-2 Infection and COVID-19, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie COMPAN, PhD (+33664915140, vcompan@brains4d.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.