NCT06099795 Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
| NCT ID | NCT06099795 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | SARS-CoV-2 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-01-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06099795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SARS-CoV-2 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06099795 currently recruiting?
Yes, NCT06099795 is actively recruiting participants. Contact the research team at vcompan@brains4d.com for enrollment information.
Where is the NCT06099795 trial being conducted?
This trial is being conducted at Nîmes, France, Nîmes, France.
Who is sponsoring the NCT06099795 clinical trial?
NCT06099795 is sponsored by Centre Hospitalier Universitaire de Nīmes. The trial plans to enroll 250 participants.