Testing a new method to detect COVID-19 using exhaled air
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
This study is testing a new breath test for COVID-19 to see if it works as well as the traditional nose swab method, especially for people showing symptoms or who have been around someone infected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT06099795 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the eBAM-CoV test, which detects SARS-CoV-2 viral proteins in exhaled air, compared to the traditional RT-PCR method that uses nasopharyngeal swabs. The eBAM-CoV test aims to provide a less invasive and more immediate assessment of viral load, particularly in symptomatic patients or those who have been in close contact with infected individuals. Researchers will analyze the concordance between the two testing methods to determine the reliability of the eBAM-CoV test for COVID-19 diagnosis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are suspected of having COVID-19, either due to symptoms or close contact with an infected person.
Not a fit: Patients who are unable to understand the testing procedures or are currently participating in another interventional study may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could offer a quicker and less invasive way to diagnose COVID-19, improving patient care and response times.
How similar studies have performed: While traditional RT-PCR testing has been widely used, the eBAM-CoV test represents a novel approach that has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Marseille and 1 other locations
- Laboratoire Alphabio, Hôpital Européen Marseille — Marseille, France (Not_yet_recruiting)
- CHU de NIMES — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Valérie COMPAN, PhD
- Email: vcompan@brains4d.com
- Phone: +33664915140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.