Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT04636294
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2020-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Borderline COVID-19 PCR Test Result
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D014777', 'term': 'Virus Diseases'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-11-18', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of positivity conversion after receiving a COVID-19 borderline PCR result.', 'timeFrame': '3 days'}], 'secondaryOutcomes': [{'measure': 'Symptoms predicting COVID-19 positivity conversion after receiving a borderline PCR result.', 'timeFrame': '1 day'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Virus']}, 'referencesModule': {'references': [{'pmid': '33689985', 'type': 'DERIVED', 'citation': 'Boeckmans J, Cartuyvels R, Hilkens P, Bruckers L, Magerman K, Waumans L, Raymaekers M. Follow-up testing of borderline SARS-CoV-2 patients by rRT-PCR allows early diagnosis of COVID-19. Diagn Microbiol Infect Dis. 2021 Jun;100(2):115350. doi: 10.1016/j.diagmicrobio.2021.115350. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Follow-up of patients with a borderline PCR result. Data of patients that were re-tested within 96 hours after receiving a borderline COVID-19 PCR result are reviewed.\n\nThis is a retrospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Ambulant (majority)\n* Hospital personnel\n* Hospitalized patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every individual that delivers a nasopharyngeal lysate for SARS-CoV-2 RNA determination by PCR.\n\nExclusion Criteria:\n\n* Patients without a previous borderline COVID-19 PCR result within 96 hours are excluded for the follow-up study.'}, 'identificationModule': {'nctId': 'NCT04636294', 'briefTitle': 'Borderline COVID-19 PCR Test Result', 'organization': {'class': 'OTHER', 'fullName': 'Jessa Hospital'}, 'officialTitle': 'Follow-up of Patients With a Borderline COVID-19 PCR Test Result', 'orgStudyIdInfo': {'id': 'f/2020/166'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result.', 'interventionNames': ['Diagnostic Test: SARS-CoV-2 PCR']}], 'interventions': [{'name': 'SARS-CoV-2 PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'SARS-CoV-2 PCR of nasopharyngeal lysate.', 'armGroupLabels': ['COVID-19 suspected by symptoms, after high-risk contact or after a borderline PCR result.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'state': 'Limburg', 'country': 'Belgium', 'facility': 'Clinical Laboratory Jessa Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jessa Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}