Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-29 @ 3:34 AM
Study NCT ID:
NCT04780334
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2021-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000087123', 'term': 'COVID-19 Nucleic Acid Testing'}], 'ancestors': [{'id': 'D000086742', 'term': 'COVID-19 Testing'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'nasopharyngeal swab and saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of CorDial-S based on the first nasopharyngeal swab taken on patient admission, compared to the final positive or negative diagnosis of COVID-19 by the medical team', 'timeFrame': 'at patient admission (Baseline)'}], 'secondaryOutcomes': [{'measure': "Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on nasopharyngeal swabs taken at patient admission.", 'timeFrame': 'at patient admission (Baseline)'}, {'measure': 'Sensitivity and specificity of CorDial-S based on the first saliva sample taken at patient admission compared to the final positive or negative diagnosis of COVID-19 by the medical team.', 'timeFrame': 'at patient admission (Baseline)'}, {'measure': "Cohen's Kappa Coefficient for concordance for the diagnosis of CoV-2-SARS between PCR and CorDial-S based on saliva samples taken at patient admission.", 'timeFrame': 'at patient admission (Baseline)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection', 'Covid19']}, 'descriptionModule': {'briefSummary': 'The main objective of this CorDial-S proof-of-concept study is to evaluate the ability to detect COVID-19 infection in nasopharyngeal swabs with CorDial-S and compare it to the PCR technique currently in use. Saliva analysis will be the subject of secondary analysis.\n\nThe CorDial-S medical device could allow the specimens to be analyzed using a small portable device and the results to be returned in minutes to the medical team and the patient, and communicated in real time with a telemedicine and remote monitoring system to the health authorities to allow the necessary protective, containment and therapeutic management measures to be put in place if necessary.\n\nThe benefits would be\n\n1. greater sensitivity\n2. a great speed because 8tests could be performed at the same time with a result in a few minutes\n3. a very high specificity at least equivalent to PCR.\n\nThis new diagnostic strategy could become extremely valuable in the fight against COVID-19, especially in the case of very long-term persistence and incomplete vaccination of the French and foreign population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to a Reference Health Establishment for suspicion of SARS-CoV-2', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female or child without age limit\n* Admitted to a Reference Health Establishment (RHS) in an emergency unit, hospitalization or intensive care unit for suspicion of SARS-CoV-2 infection regardless of clinical presentation and degree of severity.\n* Patient to be diagnosed by PCR test on nasopharyngeal swab.\n* Social insured\n\nExclusion Criteria:\n\n* Refusal of the person to participate (collection of information, second use of his sample, collection of saliva by spitting)\n* Pregnant and breastfeeding women\n* Protected Majors'}, 'identificationModule': {'nctId': 'NCT04780334', 'acronym': 'COR-DIAL-S', 'briefTitle': 'Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Rapid Detection of COVID-19 by Portable and Connected Biosensor : Biological Proof of Concept', 'orgStudyIdInfo': {'id': '2021_0063'}, 'secondaryIdInfos': [{'id': '2021-A00387-34', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive diagnosis of SARS-CoV-2', 'description': '100 patients with a positive diagnosis of SARS-CoV-2', 'interventionNames': ['Diagnostic Test: COVID-19 RT-PCR', 'Diagnostic Test: Biosensor']}, {'label': 'Negative diagnosis of SARS-CoV-2', 'description': '100 patients with a negative diagnosis of SARS-CoV-2 defined by the gold standard by the medical team', 'interventionNames': ['Diagnostic Test: COVID-19 RT-PCR', 'Diagnostic Test: Biosensor']}], 'interventions': [{'name': 'COVID-19 RT-PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasopharyngeal swabs for COVID-19 RT-PCR', 'armGroupLabels': ['Negative diagnosis of SARS-CoV-2', 'Positive diagnosis of SARS-CoV-2']}, {'name': 'Biosensor', 'type': 'DIAGNOSTIC_TEST', 'description': 'Portable and Connected Biosensor viral', 'armGroupLabels': ['Negative diagnosis of SARS-CoV-2', 'Positive diagnosis of SARS-CoV-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Roger Salengro, CHU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Enagnon Kazali ALIDJINOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}