Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-01-11 @ 4:43 PM
Study NCT ID:
NCT06177002
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D007248', 'term': 'Infertility, Male'}], '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'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-12-18', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of the androgenic hormonal environment in the blood of patients and healthy controls', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'create an international (European) registry for the management of sensitive data in epidemiological terms and pathology outcomes relating to males with confirmed COVID-19 infection and age-matched healthy controls', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19', 'Testosterone Deficiency', 'Infertility, Male']}, 'descriptionModule': {'briefSummary': 'The hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection.', 'detailedDescription': 'Preliminary data suggests that male individuals are more susceptible to COVID-19 infection, at least in Western countries, and that their mortality rate is higher than female individuals. This would seem to suggest that the hormonal environment (steroid, primarily) could have a very relevant pathophysiological role in association with SARS-CoV-2. That is, testosterone could play a relevant role in leaving male subjects more exposed to infection and more prone to developing severe complications following COVID-19 infection. Another option is that COVID-19 infection could cause a condition of acute hypogonadism, following which, the exhaustion of androgenic action could act as a co-trigger of a severe or even fatal course of the disease.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male COVID-19 patients and male healthy individuals', 'genderDescription': 'Males', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient Cohort:\n\n* Male patients with an age \\> 18 hospitalized in the departments dedicated to the care of patients affected by COVID-19 at the San Raffaele Hospital and with:\n* biological samples positive for SARS-CoV-2;\n* negative test but highly suggestive clinical and radiological picture;\n* patients discharged from the emergency room with biological samples positive for SARS-CoV-2;\n* ability to read and sign the informed consent\n\nControl Cohort:\n\n* healthy donors with an age\\> 18 accessing the IRCCS OSR Blood Donor Center;\n* ability to read and sign the informed consent\n\nExclusion Criteria:\n\n* People with an age \\< 18;\n* incapacity to read and sign the informed consent'}, 'identificationModule': {'nctId': 'NCT06177002', 'acronym': 'PROTEGGIMI', 'briefTitle': 'SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'SARS-CoV-2, TESTOSTERONE AND MALE FRAGILITY (PROTEGGIMI): A MULTIDIMENSIONAL RESEARCH PROJECT', 'orgStudyIdInfo': {'id': 'PROTEGGIMI - 01/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male COVID-19 patients', 'description': 'Male patients with an age \\> 18 affected by COVID-19 with biological samples positive for SARS-CoV-2 but with negative test', 'interventionNames': ['Diagnostic Test: Collection of biological data']}, {'label': 'male healthy individuals', 'description': 'Healthy donors with an age\\> 18 accessing the IRCCS OSR Blood Donor Center', 'interventionNames': ['Diagnostic Test: Collection of biological data']}], 'interventions': [{'name': 'Collection of biological data', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biological sample will be collected from the COVID19 patients and from healthy donors', 'armGroupLabels': ['Male COVID-19 patients', 'male healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Lombardy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Salonia, MD', 'role': 'CONTACT', 'email': 'salonia.andrea@hsr.it', 'phone': '02 2643 5661'}], 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Anna Maria Ferrara', 'role': 'CONTACT', 'email': 'ferrara.annamaria@hsr.it', 'phone': '0226437795'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Andrea Salonia', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}