Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-28 @ 12:56 PM
Study NCT ID:
NCT04516850
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2020-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients
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': 'Sub-project 1: nasopharyngeal swabs\n\nSub-project 2: tissue samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of receptors and activating proteases', 'timeFrame': '1 year', 'description': 'Determination of the level of expression of the mRNA genes'}, {'measure': 'Prevalencen of olymorphisms of the HSD3B1', 'timeFrame': '1 year', 'description': 'Determination of the prevalence of polymorphisms of the HSD3B1 patients with severe and mild-moderate SARS-CoV-2 infection'}, {'measure': 'Association of polymorphisms of the HSD3B1', 'timeFrame': '1 year', 'description': 'Evaluation of the association of polymorphisms of the HSD3B1 with clinico-pathological parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The study includes 2 sub-projects.\n\nSub-project 1: The aim is to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino.\n\nSub-project 2: The aim is to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino.', 'detailedDescription': 'Sub-project 1:\n\nThis is an observational retrospective study that aims to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2 entry and spreading in the local population of Ticino. The level of expression of these factors will be compared between infected and non-infected subjects. The sub-project will examine RNA samples from nasopharyngeal swabs taken from subjects tested for COVID-19.\n\nSub-project 2:\n\nThis is a haplotype- and diplotype-based case-control retrospective study that aims to investigate the association between the HSD3B1 gene variations and outcome of COVID-19 in the local population of Ticino. The gene status of HSD3B1 will be defined and compared between two groups of patients: the patients who experienced a severe SARS-CoV-2 infection (severe pulmonary insufficiency, ICU admission, eventually death) and the group with a mild-moderate COVID-19 disease without pulmonary insufficiency and oxygen need.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects tested for COVID-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Sub-project 1\n\nInclusion Criteria:\n\n* Availability of RNA extracted from nasopharyngeal swabs taken from subjects tested for COVID-19;\n* Subject is aged 18 years or over;\n* Written informed consent (for SARS-CoV-2 positive patients only; see §5 for further details).\n\nExclusion Criteria:\n\n\\- Documented refusal.\n\nSub-project 2\n\nInclusion Criteria:\n\n* Female and male hospitalized SARS-CoV-2 patients;\n* Patient is aged 18 years or over;\n* Availability of archival tissue samples collected at any time before SARS-CoV-2 infection for any clinical reason;\n* Clinico-pathological characteristics of the COVID-19 and clinical outcomes recorded in the EOC and Clinica Luganese Moncucco database;\n* Written informed consent (see §5 for further details).\n\nExclusion Criteria:\n\n\\- Documented refusal.'}, 'identificationModule': {'nctId': 'NCT04516850', 'briefTitle': 'HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Oncology Institute of Southern Switzerland'}, 'officialTitle': 'An Exploratory Analysis of the Expression of Receptors and Activating Proteases Mediating SARS-CoV-2 Entry and the Association Between HSD3B1 Gene Polymorphisms With Outcomes in SARS-CoV-2 Infected Patients', 'orgStudyIdInfo': {'id': 'COVID19-GeneExp'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients tested for COVID-19', 'description': 'The nasopharyngeal swabs taken from patients tested for Covid-19 who resulted infected and non-infected will be analyzed to evaluate the expression of receptors and activating proteases mediating SARS-CoV-2.', 'interventionNames': ['Genetic: Expression of receptors and activating proteases']}, {'label': 'Patients with mild-moderate and severe SARS-CoV-2 infection', 'description': 'Formalin-fixed paraffin will be analysed to determine the association between polymorphism of the HSD3B1 gene and outcomes in COVID-19 affected patients', 'interventionNames': ['Genetic: Polymorphism of the HSD3B1']}], 'interventions': [{'name': 'Expression of receptors and activating proteases', 'type': 'GENETIC', 'description': 'Level of expression of the mRNA of the genes encoding ACE2, TMPRSS2, TMPRSS4 and AR along with reference genes (beta-actin and EPCAM) in nasopharyngeal swabs taken from patients tested for COVID-19', 'armGroupLabels': ['Patients tested for COVID-19']}, {'name': 'Polymorphism of the HSD3B1', 'type': 'GENETIC', 'description': 'Formalin-fixed paraffin embedded tissue blocks will be amplified using polymerase chain reaction (PCR) based experiments followed by direct sequencing (Sanger sequencing)', 'armGroupLabels': ['Patients with mild-moderate and severe SARS-CoV-2 infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Oncology Institute of Southern Switzerland (IOSI)', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Clinica Luganese Moncucco', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}], 'overallOfficials': [{'name': 'Ricardo Pereira Mestre, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Oncology Institute of Southern Switzerland (IOSI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ricardo Pereira Mestre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Oncology Research (IOR)', 'class': 'UNKNOWN'}, {'name': 'Istituto Cantonale di Patologia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ricardo Pereira Mestre', 'investigatorAffiliation': 'Oncology Institute of Southern Switzerland'}}}}