Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04446169
Status:
COMPLETED
Last Update Posted:
2021-10-11
First Post:
2020-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
COVID-19 (SARS-CoV-2) in Urine and Semen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012639', 'term': 'Seeds'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2020-06-20', 'studyFirstSubmitQcDate': '2020-06-23', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SARS-CoV 2 presence in semen', 'timeFrame': 'Enrollment', 'description': 'SARS-CoV 2 RNA PCR in semen'}, {'measure': 'SARS-CoV 2 presence in urine', 'timeFrame': 'Enrollment', 'description': 'SARS-CoV 2 RNA PCR in urine'}, {'measure': 'Inflammation in Semen', 'timeFrame': 'Enrollment', 'description': 'Interleukin quantitative analysis in Semen, to assess if past inflammation due to SARS-CoV 2 Infection was present'}, {'measure': 'Semen quantitative and qualitative analysis', 'timeFrame': 'Enrollment', 'description': 'Spermiogram done following WHO guidelines and criteria'}], 'secondaryOutcomes': [{'measure': 'Erectile Function', 'timeFrame': 'Enrollment', 'description': 'International Index of Erectile Function (IIEF-5) questionnaire administration. Score range from 0 to 25. Higher scores mean good erectile function'}, {'measure': 'Sexual Habits', 'timeFrame': 'Enrollment', 'description': 'SExual Chronicle REcording Table (SECRET) questionnaire administration Questionnaire helps to assess the sexual habits of individuals'}, {'measure': 'Urinary function', 'timeFrame': 'Enrollment', 'description': 'International Prostate Symptom Score (IPSS) questionnaire administration Score range from 0 to 35. Higher scores mean worst urinary function'}, {'measure': 'Sexual and Ejaculatory Function', 'timeFrame': 'Enrollment', 'description': 'Male Sexual Health Questionnaire Short Form (MSHQ-SF) admnistration Higher scores mean better sexual and ejaculatory function'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV 2', 'Sexual Function', 'Fertility', 'Urine', 'Semen'], 'conditions': ['SARS-CoV 2', 'Sexual Function and Fertility Disorders', 'Urinary Function Disorders', 'Urine', 'Semen']}, 'descriptionModule': {'briefSummary': 'This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.\n\nIn human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.\n\nGiven the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.\n\nA saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer. The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.\n\nThe relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.', 'detailedDescription': 'This study is part of the current global emergency scenario due to infection with Coronavirus, SARS-CoV-2 as indicated by the international taxonomy. Study aim is to investigate the possibility of the presence of the virus within the seminal fluid and in the urine of infected patients, both during the acute phase and remotely. Current evidences show that Coronaviruses can be present inside the testicle and sperm in other species, such as in feline and avian models.\n\nIn human beings, current researches have mixed results regarding the presence of SARSCoV-2 in urine, as several studies with a large sample found no traces of the same with Real-Time Reverse method Transcriptase - Polymerase Chain Reaction or with method of nucleic acid amplification. By contrast, in just over 6% of 58 patients with Real Time Polymerase Chain Reaction method have found the presence of SARS-CoV-2 in the urine, even at a distance from the last negative nasopharyngeal swab.\n\nGiven the topicality of the problem, our study has the objective of specifically researching the presence and possible persistence over time of SARS-CoV-2 in seminal fluid and urine.\n\nA saliva sample will also be collected as a control. At the moment there are no studies in literature that tested this possibility. If confirmed, it would lead to find out another potential method of transmission, the sexual one, in asymptomatic patients or apparently no longer infectious with negative buffer.\n\nAccording to results obtained, follow up will be tailored to patients (assessment for COVID 19 infections and/or further analysis/folliow-up in case of abnormal findings) The rationale for our study is the evidence that in other species this type of transmission by coronaviruses is possible and that at present it has not been verified in mankind.\n\nThe relevance of the study would be both in the case of a negative result, as the first study in its generally, both in the case of a positive result, due to the possibility of introducing new prevention measures in the long run.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective cohort study on male patients with a documented previous infection for SARS-CoV2, including symptomatic and asymptomatic patients.Patients need to be eligible for the inclusion criteria and to sign the informed consent to be enrolled to the study', 'genderDescription': 'Semen analysis', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male Sex\n* Age\\>18 years\n* Will to participate to the study\n* Documented past infection for SARS-CoV2 (Nasopharyngeal swab positive for SARS-CoV2 RNA)\n* Current negative infection for SARS-CoV2 (Two negative Nasopharyngeal swab for SARS-CoV2 RNA, done following WHO guidelines)\n\nExclusion Criteria:\n\n* Age more than 80 years old\n* Anejaculation\n* Patient's will"}, 'identificationModule': {'nctId': 'NCT04446169', 'briefTitle': 'COVID-19 (SARS-CoV-2) in Urine and Semen', 'organization': {'class': 'OTHER', 'fullName': 'University of Florence'}, 'officialTitle': 'COVID-19 (SARS-CoV-2) in Urine and Semen: Qualitative and Quantitative Analyses and Evaluation of STD, Sexual Function, Fertility and Urinary Function', 'orgStudyIdInfo': {'id': '17104_oss/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SARS-CoV 2 Patients', 'description': 'Patients with previous nasopharyngeal swab positive for SARS-CoV-2, subsequently negativeized in two detections', 'interventionNames': ['Diagnostic Test: SARS-CoV 2 RNA PCR Urine', 'Diagnostic Test: SARS-CoV 2 RNA PCR Semen', 'Diagnostic Test: Semen Qualitative Analysis', 'Diagnostic Test: IIEF-5 questionnaire', 'Diagnostic Test: Male Sexual Health Questionnaire (MSHQ)', 'Diagnostic Test: IPSS questionnaire', 'Diagnostic Test: SECRET questionnaire', 'Diagnostic Test: Interleukin assessment in semen']}], 'interventions': [{'name': 'SARS-CoV 2 RNA PCR Urine', 'type': 'DIAGNOSTIC_TEST', 'description': 'Search for SARS-CoV 2 RNA in urine through PCR', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'SARS-CoV 2 RNA PCR Semen', 'type': 'DIAGNOSTIC_TEST', 'description': 'Search for SARS-CoV 2 RNA in Semen through PCR', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'Semen Qualitative Analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Search for Semen Alterations in patients with past SARS-CoV 2 infection', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'IIEF-5 questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'IIEF-5 assessment in patients with past SARS-CoV 2 infection', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'Male Sexual Health Questionnaire (MSHQ)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'IPSS questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'IPSS assessment in patients with past SARS-CoV 2 infection', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'SECRET questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'SECRET questionnaire assessment in patients with past SARS-CoV 2 infection', 'armGroupLabels': ['SARS-CoV 2 Patients']}, {'name': 'Interleukin assessment in semen', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present', 'armGroupLabels': ['SARS-CoV 2 Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50134', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'AOU Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'Mauro Gacci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Careggi University Hospital'}, {'name': 'Sergio Serni, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Florence'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florence', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Simone Morselli', 'investigatorAffiliation': 'University of Florence'}}}}