Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-28 @ 7:34 PM
Study NCT ID:
NCT05611203
Status:
UNKNOWN
Last Update Posted:
2023-01-11
First Post:
2022-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 4503942, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-01-10T14:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-11-03', 'studyFirstSubmitQcDate': '2022-11-08', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RT-PCR results', 'timeFrame': 'Day 1', 'description': 'The detection rate of SARS-CoV-2 RNA'}], 'secondaryOutcomes': [{'measure': 'Sycle threshold (Ct)', 'timeFrame': 'Day 1', 'description': 'SARS-CoV-2 RT-PCR cycle threshold (Ct) values'}, {'measure': 'Inconclusive tests', 'timeFrame': 'Day 1', 'description': 'Number of inconclusive RT-PCR tests results'}, {'measure': 'Test discomfort', 'timeFrame': 'Day 1', 'description': 'Self reported on a 11-point NRS-scale from 0 - 10 (with 10 being the worst imaginable discomfort)'}, {'measure': 'Development of COVID-19 disease after testing', 'timeFrame': '1 month', 'description': 'Online questionare about symptoms send by email'}, {'measure': 'Test accuracy between healthcare workers', 'timeFrame': 'Day 1', 'description': 'SARS-CoV-2 detection rate for each healthcare worker'}, {'measure': 'Participants oropharynx anatomy', 'timeFrame': 'Day 1', 'description': 'Mallampati Score of participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SARS-CoV Infection', 'Coronavirus', 'Corona Virus Infection']}, 'referencesModule': {'references': [{'pmid': '38865190', 'type': 'DERIVED', 'citation': 'Hartvigsen B, Jakobsen KK, Benfield T, Gredal NT, Ersboll AK, Gronlund MW, Bundgaard H, Andersen MP, Steenhard N, von Buchwald C, Todsen T. Molecular Detection of SARS-CoV-2 From Throat Swabs Performed With or Without Specimen Collection From the Tonsils: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 12;13:e47446. doi: 10.2196/47446.'}]}, 'descriptionModule': {'briefSummary': 'Citizens who undergo testing for COVID-19 at one of two Testcenters in Copenhagen Captial Region will be invited to participate in the study. The participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing. The swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR. The diagnostic accuracy and SARS-CoV-2 viral load will be compared. The participants will be asked to complete a questionnaire regarding their symptoms.', 'detailedDescription': 'We will include citizens referred for outpatient testing for COVID-19 who will be offered to participante in the study on a volunteer basis. Participants are all volunteers, who are attending the test facilities to obtain a PCR test. Participants are required to provide oral and written informed consent to participate before entering the study. The inclusion criterion is 18 years or more of age. Exclusion criteria are neck breathers (tracheostomy/laryngectomy patients).\n\nThe participants will be randomized to either an oropharyngeal swap including the palatine tonsils OR an oropharyngeal swap without the palatine tonsils for SARS-CoV-2 testing.\n\nThe swabs will be sent to the clinical microbiology laboratory for SARS-CoV-2 detection using RT-PCR as usual. The diagnostic accuracy and SARS-CoV-2 viral load will be compared using independent t-test. The participants will be asked to complete a questionnaire regarding their symptoms and the number of sick days. All data will be documented on-site in a secure web database (REDCap).\n\nThe primary outcome will be reported as:\n\n• SARS-CoV-2 RNA by RT-PCR test result (positive, negative, inconclusive)\n\nThe secondary outcome will be reported as:\n\n* SARS-CoV-2 RT-PCR cycle threshold (Ct) value\n* Test discomfort on a 11-point NRS-scale\n* Development of COVID-19 disease after testing\n* SARS-CoV-2 detection rate for each healthcare worker\n* Mallampati Score of participants being tested'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* citizens referred for outpatient testing for COVID-19 in Valby and Hillerød COVID-19 TestCenter.\n\nExclusion Criteria:\n\n* Age under 18 years\n* neck breathers (tracheostomy/laryngectomy patients)'}, 'identificationModule': {'nctId': 'NCT05611203', 'briefTitle': 'Should Palatine Tonsils be Included in the Oropharyngeal Swab for SARS-CoV-2 Molecular Testing?', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Molecular Detection of SARS-CoV-2 From Oropharyngeal Swabs Performed With or Without Specimen Collection From the Palatine Tonsils - a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-22022937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oropharyngeal swab only including the posterior oropharyngeal wall', 'description': 'An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall only', 'interventionNames': ['Procedure: An Oropharyngeal swab']}, {'type': 'EXPERIMENTAL', 'label': 'Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils', 'description': 'An Oropharyngeal swab is performed with the collection of specimens from the posterior oropharyngeal wall and both palatine tonsils', 'interventionNames': ['Procedure: An Oropharyngeal swab']}], 'interventions': [{'name': 'An Oropharyngeal swab', 'type': 'PROCEDURE', 'description': 'An Oropharyngeal swab performed for diagnostic purposes', 'armGroupLabels': ['Oropharyngeal swab including the posterior oropharyngeal wall and both palatine tonsils', 'Oropharyngeal swab only including the posterior oropharyngeal wall']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Copenhagen', 'state': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tobias Todsen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Hillerød Covid-19 Testcenter', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2500', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Tobias Todsen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Valby', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Tobias Todsen, MD, PhD', 'role': 'CONTACT', 'email': 'tobias.todsen@regionh.dk', 'phone': '+45 35466008'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Associate Prof', 'investigatorFullName': 'Tobias Todsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}