Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-02 @ 8:41 AM
Study NCT ID:
NCT04518735
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1707}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'From hospital admission to day 28'}, {'measure': 'Transfer to the Intensive Care Unit (ICU)', 'timeFrame': 'From hospital admission to day 28'}], 'secondaryOutcomes': [{'measure': 'Thromboembolic complications', 'timeFrame': 'From hospital admission to day 28', 'description': 'Venous thromboembolism, ischemic stroke, myocardial infarction or periferal arterial thrombosis during hospitalization for Covid19'}, {'measure': 'Major bleeding complications', 'timeFrame': 'From hospital admission to day 28', 'description': 'Any bleeding complication grade 3 or 5 according BARC classification'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Oral anticoagulant', 'VKA', 'DOAC', 'Antiplatelet therapy', 'Heparin', 'Low molecular-weight heparin'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'CORONA is a retrospective, observational, one center study to investigate the clinical evolution (in terms of survival and thromboembolic complications) of patients on chronic treatment with anticoagulants or antiplatelet agents who are admitted to the hospital for COVID-19 compared with patients who do not receive anticoagulants or antiplatelet agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of any age and sex, suffering from Covid19 needing hospital admission more than 1 day for treatment and/or supportive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient admitted for COVID-19 at the Hospital de la Santa Creu i Sant Pau,\n* Positive COVID-19 polymerase chain reaction test\n* Length of stay more than 24 hours\n\nExclusion Criteria:\n\n* No objective diagnose for COVID-19\n* Outpatient\n* Lenght of stay less than 24hours'}, 'identificationModule': {'nctId': 'NCT04518735', 'acronym': 'CORONA', 'briefTitle': 'Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients (CORONA Study)', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Evolution of COVID-19 in Anticoagulated or Antiaggregated Patients', 'orgStudyIdInfo': {'id': 'IIBSP-COV-2020-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients on previous oral anticoagulant treatment', 'description': 'Patients receiving chronic anticoagulation with vitamin K antagonists (VKA, warfarin or acenocumarol) or with DOACs (dabigatran, rivaroxaban, apixaban or edoxaban) for any indication', 'interventionNames': ['Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19']}, {'label': 'Patients on previous antiplatelet therapy', 'description': 'Patients receiving chronic antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor, cangrelor, dipyridamol) for any indication', 'interventionNames': ['Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19']}, {'label': 'Patients without antithrombotic therapy', 'description': 'Patients receiving nor chronic oral anticoagulation neither chronic antiplatelet therapy', 'interventionNames': ['Other: Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19']}], 'interventions': [{'name': 'Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19', 'type': 'OTHER', 'description': 'Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy', 'armGroupLabels': ['Patients on previous antiplatelet therapy', 'Patients on previous oral anticoagulant treatment', 'Patients without antithrombotic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}