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

COVID-19 Clinical Trial

— eBAM_CoV  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099795
• Other study ID #: IDIL/2022/VC-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Valérie COMPAN, PhD
• Phone: +33664915140
• Email: vcompan[@]brains4d.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• COVID-19
• SARS-CoV-2 Infection

Intervention

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

Locations

Country	Name	City	State
France	Laboratoire Alphabio, Hôpital Européen Marseille	Marseille
France	CHU de NIMES	Nîmes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	brains' laboratory sas, FRANCE, University of Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 0
Secondary	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).	Day 0
Secondary	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	Day 0
Secondary	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	Day 4
Secondary	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	Day 0