Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 12:58 AM
Study NCT ID:
NCT04386551
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of COVID-19 in Saliva Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'nasopharyngeal sample and saliva sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-05-11', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of SARS-CoV-2 RNA in the saliva sample', 'timeFrame': 'day 1', 'description': 'Detection of SARS-CoV-2 RNA in the saliva sample'}, {'measure': 'Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results', 'timeFrame': 'day 1', 'description': 'Concordance between the Saliva sample and the nasonasopharyngeal sample SARS-CoV-2 RT-PCR results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sars-CoV2', 'RT-PCR', 'Saliva collection', 'nasopharyngeal sample'], 'conditions': ['Sars-CoV2', 'RT-PCR', 'Saliva Collection', 'Nasopharyngeal Sample']}, 'descriptionModule': {'briefSummary': 'Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China. The reference diagnosis is based on the search for the SARS-COV-2 genome in the nasopharyngeal sample.\n\nCarrying out this sample requires the competence of a healthcare professional and presents some inconveniences for the tested patient. Because saliva collection is simple, non-invasive, painless and inexpensive, and can be performed by poorly trained personnel, it could be an alternative to the reference nasopharyngeal sample. SARS-CoV2 detection in human saliva could be a potential diagnosis of COVID infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ambulatory patients screened for SARS Cov 19 at the CHU Amiens COViD clinic will be included in the study. A double sample will be taken from the saliva and the nasopharynx in parallel using the same sample kit. This double sampling has no direct impact on conventional patient management.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient hospitalized at the Amiens CHU in a COVID-19 unit\n* patient seen as outpatient in the area of infectious pathologies for COVID-19 infection\n\nExclusion Criteria:\n\n* Patients under 18\n* patients under guardianship or curators'}, 'identificationModule': {'nctId': 'NCT04386551', 'acronym': 'SALICOV', 'briefTitle': 'Detection of COVID-19 in Saliva Collection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of the Performance of a Saliva Sample Versus a Nasopharyngeal Sample in the Diagnosis of COVID-19 by RT-PCR', 'orgStudyIdInfo': {'id': 'PI2020_843_0045'}}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}