Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT05024461
Status:
UNKNOWN
Last Update Posted:
2021-08-27
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], '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': 'D018352', 'term': 'Coronavirus Infections'}, {'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': 'ACTUAL', 'count': 1159}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-11-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-26', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of salivary test vs. nasopharyngeal test', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': '- Proportion of analyses not performed on salivary samples for the following reasons (vs. number of salivary sample analyses performed): o Insufficient quantity of biological sample, o Inability to collect the sample', 'timeFrame': '1 day'}, {'measure': 'Perception of the tests by questionnaire (proportion of positive opinions)', 'timeFrame': '1 day'}, {'measure': 'Perception of the tests by questionnaire (proportion of negative opinions)', 'timeFrame': '1 day'}, {'measure': 'Positivity and negativity of the salivary test vs. symptomatology and associated terrain', 'timeFrame': '1 day'}, {'measure': 'Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the clinical context', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity analysis between the salivary test and the nasopharyngeal test according to the time between the samples and the onset of symptoms, the time between the samples and the contact with an index case, the known immunodepression and the clinical context (diabetes, pregnancy)'}, {'measure': 'Description of the aspect of the saliva collected: mucous or fluid', 'timeFrame': '1 day', 'description': 'Description of the analytical criteria of the saliva sample'}, {'measure': 'Volume of saliva collected (mL)', 'timeFrame': '1 day', 'description': 'Description of the analytical criteria of the saliva sample: (pipette measurement, if the saliva is not fluid, pipette measurement after vortexing for 1 min)'}, {'measure': 'Description of the analytical criteria of the saliva sample:pre-analytical treatments if necessary', 'timeFrame': '1 day'}, {'measure': 'Number of Cycle threeshold for the first analysis (done at the Cayenne hospital) and the second analysis (done at the university hospital of Caen)', 'timeFrame': '1 day'}, {'measure': '- Sensitivity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)', 'timeFrame': '1 day'}, {'measure': '- Specificity of salivary test vs nasopharyngeal test with strong positives (3 genes detected)', 'timeFrame': '1 day'}, {'measure': '- Sensitivity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)', 'timeFrame': '1 day'}, {'measure': '- Specificity of salivary test vs nasopharyngeal test with weak positives (1 gene detected)', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'Multicenter observational study of diagnostic test validation (Research Involving the Human Person, type 3) In addition to the diagnosis by the reference method (nasopharyngeal swab), the patient will be asked to provide a saliva sample via a salivary spit. The clinical circumstances of the diagnosis, the age of the patient, the associated terrain (diabetes, immunodepression, pregnancy) will be noted. The nasopharyngeal and saliva samples will be analyzed in Cayenne and the remaining samples will be frozen and stored at the CRB before being sent to the University Hospital of Caen for analysis and concordance verification.\n\nThe expected benefits are:\n\nPossibility of repeating tests in the same person more easily due to the absence of pain and thus reduce the barriers to diagnosis and screening.\n\nPossibility of self-sampling, which could simply be sent to the laboratory, which would relieve the diagnostic sites that mobilize staff and require a fairly heavy organization. Avoid long waiting lines that can be an obstacle and lead to a renunciation of the diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with an indication to perform a COVID diagnostic test (symptomatology, contact case, systematic screening etc...)\n* Men and women at least 3 years old\n\nExclusion Criteria:\n\n* Refusal of the patient or his legal representative,\n* Taking treatments that reduce salivary volume (anticholinergic activity)\n* Impossibility to perform the nasopharyngeal test\n* Patient under guardianship or curatorship, persons placed under protective measures'}, 'identificationModule': {'nctId': 'NCT05024461', 'acronym': 'COVISAL', 'briefTitle': 'Comparison of Detection of SARS-CoV2 (COVID-19) Between Nasopharyngeal Swab Specimens and Those Obtained by Salivary Sputum', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Cayenne'}, 'officialTitle': 'Comparison of the Results, Feasibility and Acceptability of Molecular Detection of SARS-CoV2 Between Nasopharyngeal Swab Specimens Recovered in Virological Transport Medium and Those Obtained by Salivary Sputum', 'orgStudyIdInfo': {'id': 'COVISAL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with an indication for a COVID19 test', 'description': 'The persons included will be those who have an indication for a COVID 19 test and who present themselves at the Cayenne hospital and during the screening missions organised by the Red Cross and Médecin du Monde during the COVID 19 epidemic in the territory', 'interventionNames': ['Diagnostic Test: Salivary test for COVID19']}], 'interventions': [{'name': 'Salivary test for COVID19', 'type': 'DIAGNOSTIC_TEST', 'description': 'Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center,\n\n* Pre-analytical particularities and analytical particularities\n* Cycle threeshold\n* Demographic variables\n* Clinical variables\n* Clinical criteria\n* Questionnaire on the perception of the 2 sampling methods', 'armGroupLabels': ['Patient with an indication for a COVID19 test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97306', 'city': 'Cayenne', 'country': 'French Guiana', 'facility': 'General Hospital of Cayenne', 'geoPoint': {'lat': 4.9381, 'lon': -52.33455}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Cayenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}