Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2026-02-23 @ 4:10 AM
Study NCT ID:
NCT04780295
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], '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': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2708}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatal or non-fatal venous thromboembolism (VTE)', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Rate of thromboembolic events encompassing pulmonary embolism (PE) and deep vein thrombosis (DVT)'}, {'measure': 'Fatal or non-fatal cardiovascular events', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Rate of cardiovascular events encompassing stroke and myocardial infarction'}, {'measure': 'All-cause death', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Rate of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Prevalence of cardiovascular risk factors', 'timeFrame': 'at baseline/enrollment', 'description': 'Baseline prevalence of cardiovascular risk factors and use of specific medications (statins, Angiotensin-converting enzyme \\[ACE\\] inhibitors)'}, {'measure': 'Length of hospitalization', 'timeFrame': 'first index hospitalization for Covid19', 'description': 'Duration of inpatient stay'}, {'measure': 'Prevalent use of in-hospital thromboprophylaxis', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Use of unfractionated heparin (UFH), low-molecular weight heparin (LMWH), or direct oral anticoagulants (DOAC) on/after admission due to Covid19'}, {'measure': 'In-hospital course of D-dimer (μg/mL)', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Course of laboratory biomarker'}, {'measure': 'In-hospital course of Troponin (ng/ml)', 'timeFrame': 'during index hospitalization for Covid19', 'description': 'Course of laboratory biomarker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'thromboembolism', 'thromboprophylaxis', 'pulmonary embolism', 'anticoagulation'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (Covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with Covid19. This will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with Covid19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Given the observational nature of this registry, no exclusion criteria will be applied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (SARS-CoV2)\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT04780295', 'acronym': 'CORE-THROMB', 'briefTitle': 'Coronavirus Disease (COvid-)19 REgistry on THROMBOSIS Complications', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'COvid-19 REgistry on THROMBOSIS Complications Associated With Hospitalization', 'orgStudyIdInfo': {'id': 'CTH C010'}, 'secondaryIdInfos': [{'id': 'DRKS00022277', 'type': 'REGISTRY', 'domain': 'DRKS (Deutsches Register klinischer Studien, engl.: German Clinical Studies Register)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13083-970', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'Unicamp (Universidade Estadual de Campinas; University of Campinas)', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '01308-050', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Sírio-Libanês', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '02012-021', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Campanha Anhembi', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Amager and Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40472', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Augusta-Krankenhaus Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '12559', 'city': 'Köpenick', 'country': 'Germany', 'facility': 'DRK Kliniken Berlin Köpenick', 'geoPoint': {'lat': 52.44254, 'lon': 13.58228}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80639', 'city': 'Munich', 'country': 'Germany', 'facility': 'Krankenhaus Neuwittelsbach', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '90419', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Paracelsus Medizinische Privatuniversität am Klinikum Nuernberg', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '14050', 'city': 'Westend', 'country': 'Germany', 'facility': 'DRK Kliniken Berlin Westend', 'geoPoint': {'lat': 52.51708, 'lon': 13.27636}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '40126', 'city': 'Bologna', 'country': 'Italy', 'facility': 'University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '22100', 'city': 'Como', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale (ASST) Lariana', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'zip': '22036', 'city': 'Erba', 'country': 'Italy', 'facility': 'Ospedale Sacra Famiglia Fatebenefratelli', 'geoPoint': {'lat': 45.8088, 'lon': 9.22609}}, {'zip': '61032', 'city': 'Fano', 'country': 'Italy', 'facility': 'Presidio Ospedaliero Santa Croce di Fano', 'geoPoint': {'lat': 43.84052, 'lon': 13.01665}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '42016', 'city': 'Guastalla', 'country': 'Italy', 'facility': 'Ospedale Civile di Guastalla - Azienda Unità Sanitaria Locale (AUSL) Reggio Emilia', 'geoPoint': {'lat': 44.91172, 'lon': 10.66186}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Ospedale Maggiore di Parma - Azienda Ospedaliero Universitaria di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '29015', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Ospedale Civile di Castel San Giovanni - Azienda Unità Sanitaria Locale (AUSL) di Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '42123', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Santa Maria Nuova Hospital - Azienda Unità Sanitaria Locale (AUSL) IRCCS di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'IRCCS Humanitas Clinical and Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': "Università degli studi dell' Insubria (University of Insubria)", 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiologia Ignacio Chavez (National Institute of Cardiology Igancio Chavez)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '29004', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Quirónsalud', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '34768', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Erdem Medical Center', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Stavros Konstantinides, MD, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Mainz, Johannes Gutenberg University Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Stavros Konstantinides, MD, Medical Director of the', 'investigatorFullName': 'Prof. Stavros Konstantinides, MD', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}