Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT05151094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-09
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}, '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': 'ESTIMATED', 'count': 6000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Incidence of venous or arterial thrombotic events', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of arterial or venous thromboses proven by objective imaging (ultrasound, computerized tomography, magnetic resonance imaging, scintigraphy) and laboratory (troponin) methods.'}, {'measure': 'Incidence of major bleeding', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of bleeding events that can be classified by the International Society on Thrombosis and Haemostasis criteria as major bleeding.'}, {'measure': 'Incidence of bacteriemia', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of positive blood cultures that were taken based on clinical suspicion for bacterial co-infection.'}, {'measure': 'Incidence of mechanical ventilation', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of mechanical ventilation use required for deteriorating respiratory function.'}, {'measure': 'Incidence of intensive care unit admission', 'timeFrame': 'At 30-days from hospital admission', 'description': 'Incidence of intensive care unit admission required for intensive/critical level of care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Thrombosis', 'Bleeding', 'Sepsis', 'Mechanical Ventilation Complication', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': "Aim of this project is to understand clinical features, clinical outcomes and efficacy and safety profiles of different therapies by analyzing a cohort of COVID-19 patients hospitalized and treated in a tertiary-level institution, University hospital Dubrava. Patients' clinical and laboratory characteristics, drug exposure and outcomes are obtained by analysis of written and electronical medical records.", 'detailedDescription': 'University Hospital Dubrava has been completely repurposed during the COVID-19 pandemic to become high volume COVID-19 tertiary institution. Establishment of hospital registry project is necessary to properly understand disease characteristic, related outcomes and real-life treatment patterns. Registry provides a fundamental framework for future upgrading with emerging or retrogradely obtained specific data that will substantially facilitate understanding of COVID-19 in the context of other specific diseases, therapies and procedures. Large comprehensive database will provide sufficient statistical power to allow for investigation of large number of subgroups and existence of interactions between different variables. Assessment of large number of clinically important outcomes (mortality, occurrence of venous and arterial thromboses, major bleeding, bacteriemia, incidence of mechanical ventilation and intensive care unit admission) is necessary to put any investigated parameter in the proper efficacy and safety context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that were hospitalized in our institution due to the COVID-19 infection', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all hospitalized patients positive for COVID-19\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05151094', 'acronym': 'COVID-19', 'briefTitle': 'Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Dubrava'}, 'officialTitle': 'Registry of Hospitalized Patients in University Hospital Dubrava Respiratory Center', 'orgStudyIdInfo': {'id': '2021/2503-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Remdesivir exposure', 'description': 'Patients treated with remdesivir due to the COVID-19 infection', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'Observation of clinical outcomes and comparison to non-treated patients', 'armGroupLabels': ['Remdesivir exposure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'state': 'City of Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'overallOfficials': [{'name': 'Marko Lucijanic, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital Dubrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Dubrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Marko Lucijanić', 'investigatorAffiliation': 'University Hospital Dubrava'}}}}