Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
eBAM Cov Testing
DeviceEvaluation 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
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Patients likely to be affected by COVID-19Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Day 0Secondary outcomes
1
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).
Time frame
Day 02
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
Time frame
Day 03
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
Time frame
Day 44
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
Time frame
Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier Universitaire de Nīmes
Lead sponsor
University of Nimes
Collaborator
brains' laboratory sas, FRANCE
Collaborator
Source ClinicalTrials.gov