Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT04775134
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Lung tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reverse transcriptase-PCR', 'timeFrame': 'Single time point.', 'description': 'Detection of SARS-CoV-2 RNA in lung tissue homogenate with primers targeting both genomic and subgenomic RNA'}, {'measure': 'Fluorescence immunohistochemistry (IHC)', 'timeFrame': 'Single time point.', 'description': 'Determining the histological presence of SARS-CoV-2 viral proteins in lung tissue with commercially available antibodies against the SARS-CoV-2 spike and nucleocapsid proteins'}, {'measure': 'Single molecule fluorescence in situ hybridization (smFISH)', 'timeFrame': 'Single time point.', 'description': 'Determining the presence of SARS-COV-2 viral RNA in lung tissue with commercially available probes targeting both sense and anti-sense viral RNA'}], 'secondaryOutcomes': [{'measure': 'Viral culture', 'timeFrame': 'Single time point.', 'description': 'Determining viability of SARS-CoV-2 in case of a low revere transcriptase-PCR cycling threshold'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to confirm or rule out the residual presence and viability of SARS- CoV-2 in the respiratory tract and lung parenchyma of patients previously infected with SARS-CoV-2.\n\nPresence and viability of SARS-CoV-2 in lung tissue will be assessed with reverse transcriptase-polymerase chain reaction (PCR) and viral culture. The histological location of residual SARS-CoV-2 will be determined with fluorescence immunohistochemistry and single molecule fluorescence in situ hybridization, targeting viral proteins and RNA respectively.', 'detailedDescription': 'The investigators will collect residuary lung tissue after medically indicated pulmonary resections at the Thoracic Surgery Department of University Hospitals Leuven. More specifically the investigators will collect lung tissue from patients that had earlier PCR proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies.\n\nFurthermore, for negative control of the methodology the investigators will also collect lung tissue from patients that have no signs for earlier SARS-CoV-2 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring a medically indicated pulmonary resection.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient requires medically indicated pulmonary resection\n* Informed consent\n\nExclusion Criteria:\n\n* Active SARS-CoV-2 infection/COVID-19\n* No informed consent'}, 'identificationModule': {'nctId': 'NCT04775134', 'acronym': 'REASSURE', 'briefTitle': 'Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma (After SARS-CoV-2 Infection or COVID-19)', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Residual SARS-CoV-2 Presence in the Respiratory Tract and Lung Parenchyma', 'orgStudyIdInfo': {'id': 'S64988'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies', 'description': 'Patients that require a medically indicated pulmonary resection.', 'interventionNames': ['Diagnostic Test: Lung biopsy']}, {'label': 'Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies', 'description': 'Patients that require a medically indicated pulmonary resection.', 'interventionNames': ['Diagnostic Test: Lung biopsy']}], 'interventions': [{'name': 'Lung biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biopsy of residuary material from a medically indicated pulmonary resection', 'armGroupLabels': ['Subjects WITHOUT earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies', 'Subjects with earlier PCR-proven COVID-19 and/or serum anti-SARS-CoV-2 antibodies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Laurens J Ceulemans, MD, PhD', 'role': 'CONTACT', 'email': 'laurens.ceulemans@uzleuven.be', 'phone': '+ 32 16 34 34 25'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Laurens J Ceulemans, MD, PhD', 'role': 'CONTACT', 'email': 'laurens.ceulemans@uzleuven.be', 'phone': '+ 32 16 34 34 25'}], 'overallOfficials': [{'name': 'Laurens J Ceulemans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}