Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-01 @ 6:53 PM
Study NCT ID:
NCT06099795
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection', 'timeFrame': 'Day 0', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'diagnostic performance of the eBAM-CoV test', 'timeFrame': 'Day 0', 'description': 'Preliminarily assess the diagnostic performance of the eBAM-CoV test by measuring the sensitivity/specificity between the eBAM-CoV method and the reference RT-PCR method (known as the "gold standard") for detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contact).'}, {'measure': 'concentration of SARS-CoV-2 viral proteins', 'timeFrame': 'Day 0', 'description': 'Correlation between the concentration of SARS-CoV-2 viral proteins assessed by the eBAM-CoV test (eBAM-Unit) and the mean number of copies of mRNA encoding a protein fraction of SARS-CoV-2 viral proteins assessed using the RT-PCR technique'}, {'measure': 'Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR', 'timeFrame': 'Day 4', 'description': 'Number of patients detected as positive by eBAM-CoV and negative by RT-PCR at Day 0 whose RT-PCR test becomes positive at Day 4'}, {'measure': 'Concordance between eBAM-CoV test and antigenic test', 'timeFrame': 'Day 0', 'description': 'Concordance between the eBAM-CoV method and the antigenic test in patients likely to be infected with COVID-19 and volunteering for a second nasopharyngeal swab'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diagnostic Test Kits'], 'conditions': ['SARS-CoV-2 Infection', 'COVID-19', 'Coronavirus']}, 'descriptionModule': {'briefSummary': '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.\n\nTo 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female patients over 18 years of age (≥)\n* Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening.\n\nExclusion Criteria:\n\n* Inability to understand the procedures to use the device\n* Patient participating in an another interventional study\n* Patient in exclusion period determined by another study\n* Patient under court protection or guardianship\n* Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.\n* Pregnant, parturient or breast-feeding patient'}, 'identificationModule': {'nctId': 'NCT06099795', 'acronym': 'eBAM_CoV', 'briefTitle': 'Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IDIL/2022/VC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients likely to be affected by COVID-19', 'description': '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.', 'interventionNames': ['Device: eBAM Cov Testing']}], 'interventions': [{'name': 'eBAM Cov Testing', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Patients likely to be affected by COVID-19']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe HALFON, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.halfon@biogroup.fr', 'phone': '+33413428120'}, {'name': 'Philippe HALFON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laboratoire Alphabio, Hôpital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '30029', 'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Paul LOUBET, MD, PhD', 'role': 'CONTACT', 'email': 'paul.loubet@chu-nimes.fr', 'phone': '+33466684149'}, {'name': 'Paul LOUBET, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de NIMES', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Valérie COMPAN, PhD', 'role': 'CONTACT', 'email': 'vcompan@brains4d.com', 'phone': '+33664915140'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Nimes', 'class': 'OTHER'}, {'name': "brains' laboratory sas, FRANCE", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}