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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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SARS-CoV-2 Infection COVID-19 Coronavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients likely to be affected by COVID-19

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.

Group Type EXPERIMENTAL

eBAM Cov Testing

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes