Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-01 @ 7:45 AM
Study NCT ID:
NCT04599959
Status:
COMPLETED
Last Update Posted:
2021-07-26
First Post:
2020-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.\n\nInvestigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.\n\nBI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 day.', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nTwo samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.\n\nAdditional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Swab - Processed in Mexico', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nAdditional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.\n\nParticipants whose swab samples were processed in Mexico and had non-missing results were included in this group.'}, {'id': 'OG001', 'title': 'Saliva - Processed in Mexico', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nAdditional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.\n\nParticipants whose saliva samples collected via Salivette® Cortisol were processed in Mexico and had non-missing results were included in this group.'}], 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Ambiguous', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline (the test day), up to one day.', 'description': 'Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and whose samples were processed in Mexico.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Swab+Saliva - Processed in Germany', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nTwo samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.\n\nParticipants with both swab and saliva samples and whose samples were processed in Germany and had non-missing results were included in this group.'}], 'classes': [{'title': 'True positive (sensitivity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}]}]}, {'title': 'True negative (specificity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline (the test day), up to one day.', 'description': 'Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and had both swab and saliva sample that were processed in Germany.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nTwo samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.\n\nAdditional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study compared the viral Ribonucleic acid (RNA) test sample taken for Quantitative reverse transcription polymerase chain reaction (RT-qPCR) via a nasopharyngeal swab versus saliva collected with Salivette® Cortisol in the diagnosing of SARS-CoV-2 virus infection.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.\n\nTwo samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.\n\nAdditional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43.4', 'spread': '14.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-28', 'size': 453858, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-21T04:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2020-10-22', 'resultsFirstSubmitDate': '2021-07-21', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-21', 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico', 'timeFrame': 'At baseline (the test day), up to one day.', 'description': 'Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.'}, {'measure': 'Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany', 'timeFrame': 'At baseline (the test day), up to one day.', 'description': 'Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid-19']}, 'referencesModule': {'references': [{'pmid': '37724431', 'type': 'DERIVED', 'citation': 'Moroni-Zentgraf P, Keller C, Eschenfelder CC, Walter Muller H, Sigmund R, Galeana-Cadena D, Marquez-Garcia JE, Moncada-Morales A, Zuniga JA. Salivette(R) Cortisol versus oropharyngeal swabbing for the detection of SARS-CoV-2 infection. Expert Rev Mol Diagn. 2023 Jul-Dec;23(11):1011-1014. doi: 10.1080/14737159.2023.2260308. Epub 2023 Oct 24.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Click here to connect to Boehringer Ingelheim Clinical Studies Website'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the tests is to establish saliva collection with Salivette® Cortisol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Informed consent form signed and dated before any samples have been taken.\n2. Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days.\n3. Male and/or female patients aged 18 years and over.'}, 'identificationModule': {'nctId': 'NCT04599959', 'briefTitle': 'COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'COVID-19 Tests: a Systematic Comparison of Viral RNA Test Sample Taking for RT-qPCR, in This Case With a Nasopharyngeal Swab or Saliva Collected With Salivette® Cortisol, to Diagnose SARS-CoV-2 Virus Infection', 'orgStudyIdInfo': {'id': '0352-2150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Overall (Swab/Saliva)', 'interventionNames': ['Diagnostic Test: Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol']}], 'interventions': [{'name': 'Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit', 'armGroupLabels': ['Overall (Swab/Saliva)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'México', 'country': 'Mexico', 'facility': 'Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:\n\n1. studies in products where Boehringer Ingelheim is not the license holder;\n2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;\n3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).\n\nFor more details refer to: http://trials.boehringer-ingelheim.com/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}