Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 1:53 AM
Study NCT ID:
NCT04497194
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of COVID-19 Patients at AOUI Verona
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}, 'targetDuration': '60 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Epidemiological data including demographic data, contact with COVD-19 positive patients and onset of symptoms.'}, {'measure': 'Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Underlying chronic diseases, signs/symptoms related with COVID-19 diseases an clinical presentation on admission'}, {'measure': 'Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Body temperature (°C)'}, {'measure': 'Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Blood pressure (mmHg)'}, {'measure': 'Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Pulse rate (beats per minute)'}, {'measure': 'Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Pulse rate (beats per minute)'}, {'measure': 'Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Peripheral oxygen saturation (%)'}, {'measure': 'C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'CRP (m/gL)'}, {'measure': 'Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'PCT (ng/mL'}, {'measure': 'White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'White Blood Count (WBC, cell/mm3)'}, {'measure': 'Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Neutrophils (cell/mm3)'}, {'measure': 'Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Lymphocytes (cell/mm3)'}, {'measure': 'Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Platelets (cell/mm3)'}, {'measure': 'L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'LDH (mU/ml)'}, {'measure': 'Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'CK (U/L)'}, {'measure': 'D-dimer (μg/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'D-dimer (μg/L)'}, {'measure': 'fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'fibrinogen (g/L)'}, {'measure': 'ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'ferritin (mcg/L)'}, {'measure': 'AST (U/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'AST (U/L)'}, {'measure': 'ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'ALT (U/L)'}, {'measure': 'Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Creatinine (mg/dl)'}, {'measure': 'Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'pH'}, {'measure': 'Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'pO2 (mmHg)'}, {'measure': 'Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'pCO2 (mmHg)'}, {'measure': 'Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'HCO3 (mmol/l)'}, {'measure': 'Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'SpO2 (%)'}, {'measure': 'Host-related factors associated with the pathogenesis of COVID-19', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'IL-6 (pg/mL)'}, {'measure': 'Virological factors associated with the pathogenesis of COVID-19', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'Nasal and rectal swabs, fecal samples and blood samples'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronavirus Disease 2019']}, 'descriptionModule': {'briefSummary': 'The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.', 'detailedDescription': "Anamnestic data are collected at the enrollment, while all the other clinical and epidemiological information are retrieved retrospectively from patients' medical records and electronic health records.\n\nSerological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs) are collected within 48 hours after admission and during the hospital stay, according with routine internal procedures.The biological samples are stored at the University Laboratory for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM).\n\nA dedicated database has been created and implemented to collect all the above mentioned information."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing swab;\n* All ages;\n* All genders;\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Failure to obtain the informed consent.'}, 'identificationModule': {'nctId': 'NCT04497194', 'briefTitle': 'Registry of COVID-19 Patients at AOUI Verona', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona)', 'orgStudyIdInfo': {'id': 'COVID19-VR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'not applicable (observational study)', 'type': 'OTHER', 'description': 'not applicable (observational study)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Verona', 'country': 'Italy', 'facility': 'University Hospital of Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Evelina Tacconelli', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Integrata Verona'}}}}