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

NCT06099795 | Recruiting

• 1 other identifier: IDIL/2022/VC-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Diagnostic Test Kits

Outcome Measures

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).

  Day 0

Secondary Outcomes (4)

• diagnostic performance of the eBAM-CoV test

  Day 0

• concentration of SARS-CoV-2 viral proteins

  Day 0

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

  Day 4

• Concordance between eBAM-CoV test and antigenic test

  Day 0

Study Arms (1)

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.

Device: eBAM Cov Testing

Interventions

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

Patients likely to be affected by COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to understand the procedures to use the device
• Patient participating in an another interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• University of Nimes: collaborator
• brains' laboratory sas, FRANCE: collaborator

Study Sites (2)

Laboratoire Alphabio, Hôpital Européen Marseille

Marseille, 13003, France

NOT YET RECRUITING

CHU de NIMES

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Valérie COMPAN, PhD

CONTACT

+33664915140; vcompan@brains4d.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 25, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)