Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04497402
Status:
UNKNOWN
Last Update Posted:
2022-01-13
First Post:
2020-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sex-Informed Data in the COVID-19 Pandemic.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003075', 'term': 'Coitus'}, {'id': 'D013927', 'term': 'Thrombosis'}], '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': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, blood cell pellets and faeces'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-27', 'studyFirstSubmitDate': '2020-07-31', 'studyFirstSubmitQcDate': '2020-07-31', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sex differences in platelet and immune function and COVID19 severity', 'timeFrame': '3 months', 'description': 'Sex differences in biomarkers of platelet and immune function correlate with severity of disease'}], 'secondaryOutcomes': [{'measure': 'Gut microbiome and COVID19 severity', 'timeFrame': '3 months', 'description': 'Differences in the gut microbiome correlate with severity of disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sex', 'gender', 'thrombosis', 'immunity', 'gut microbiota'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': "Sex and gender matter to health equity, especially in a pandemic. Sex (a biological attribute) and gender (a social construct) may influence an individual's susceptibility, vulnerability and exposure to infectious disease. In previous coronavirus epidemics (SARS and MERS), male sex was associated with worse outcomes. Both immune and the hemostatic response display ample sexual dimorphism.\n\nThe primary aim of the study is to determine whether sex differences in biomarkers of platelet and immune function, gut microbiome, clinical characteristics, therapy, clinical cost sensitive outcomes (i.e. in-hospital transition of care, case severity, and mortality due to COVID-19) exist in patients affected by COVID-19."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with laboratory confirmed SARS-Cov-2 infection (positive for real-time reverse-transcriptase polymerase-chain reaction assay for pharyngeal swab specimens) of any severity (from asymptomatic to severe manifestations).', 'genderDescription': 'We will apply the gender framework as defined by the Canadian Institutes for Health Research (CIHR) which includes 4 gender domains: Gender Identity; Gender Roles; Gender Relations; and Institutionalized Gender (https://cihr-irsc.gc.ca/e/50836.html). Such factors include occupation, employment, marital status, number of children, and household responsibilities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with laboratory confirmed SARS-Cov-2 infection of any severity.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Younger than 18 years of age.'}, 'identificationModule': {'nctId': 'NCT04497402', 'acronym': 'G-COV', 'briefTitle': 'Sex-Informed Data in the COVID-19 Pandemic.', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Sex-Informed Data in the COVID-19 Pandemic.', 'orgStudyIdInfo': {'id': 'SAPIENZAGENDERCOVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'female COVID19 patients', 'description': 'Females with COVID19 disease'}, {'label': 'male COVID19 patients', 'description': 'Males with COVID19 disease'}, {'label': 'female matched COVID19-free patients', 'description': 'Free from disease COVID19 Females matched.'}, {'label': 'male matched COVID19-free patients', 'description': 'Free from disease COVID19 males matched.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00166', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefania Basili, MD', 'role': 'CONTACT', 'email': 'stefania.basili@uniroma1.it', 'phone': '+390649972018'}, {'name': 'Stefania Basili, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lucia Stefanini, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valeria Raparelli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Guido Antonelli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefano Corradini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roberto Cangemi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Claudio Mastroianni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcella Visentini, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maria Ciardi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sapienza University of Rome - Policlinico Umberto I Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Stefania Basili, MD', 'role': 'CONTACT', 'email': 'stefania.basili@uniroma1.it', 'phone': '0649972018'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor of Internal Medicine', 'investigatorFullName': 'Stefania Basili', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}