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NCT06099795 | RECRUITING | SARS-CoV-2 Infection

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

Nīmes University Hospital Center

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.

Condition or disease

SARS-CoV-2 Infection

COVID-19

Coronavirus

Intervention/treatment

eBAM Cov Testing

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 250 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
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
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2

Location Details

NCT06099795

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

France,

Alphabio laboratory, Marseille European Hospital

Marseille, France, 13003

RECRUITING

France,

chu's NI MES

Nîmes, France, 30029