Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 7:54 AM
Study NCT ID:
NCT04359212
Status:
COMPLETED
Last Update Posted:
2020-09-17
First Post:
2020-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D013927', 'term': 'Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D000077425', 'term': 'Fondaparinux'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009844', 'term': 'Oligosaccharides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism', 'timeFrame': '28 days', 'description': 'the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism'}], 'secondaryOutcomes': [{'measure': 'the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism', 'timeFrame': '28 days', 'description': 'the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 pandemic', 'Thromboembolism, Venous', 'Deep Venous Thrombosis', 'Pulmonary Thrombosis'], 'conditions': ['COVID-19 Disease', 'Thromboembolism, Venous']}, 'referencesModule': {'references': [{'pmid': '35244208', 'type': 'DERIVED', 'citation': 'Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.'}, {'pmid': '33502773', 'type': 'DERIVED', 'citation': 'Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.', 'detailedDescription': 'Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients aged \\> 18 years with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease (Group 1) or to the ICU for a severe to critical disease (Group 2) will be eligible for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged \\>= 18 years\n* needing admission to a medical hospital division or to an ICU\n* with a confirmed infection for COVID-19\n\nExclusion Criteria:\n\n* aged \\< 18 years'}, 'identificationModule': {'nctId': 'NCT04359212', 'acronym': 'VTE-COVID', 'briefTitle': 'Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Quovadis Associazione'}, 'officialTitle': 'Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)', 'orgStudyIdInfo': {'id': 'VTE-COVID'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medical', 'description': 'subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease', 'interventionNames': ['Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux']}, {'label': 'Intensive', 'description': 'subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease', 'interventionNames': ['Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux']}], 'interventions': [{'name': 'thromboprophylaxis with low-molecular-weight heparin or fondaparinux', 'type': 'DRUG', 'otherNames': ['thromboprophylaxis'], 'description': 'thromboprophylaxis with low-molecular-weight heparin or fondaparinux', 'armGroupLabels': ['Intensive', 'Medical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35138', 'city': 'Padua', 'country': 'Italy', 'facility': 'Giuseppe Camporese', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Paolo Simioni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, University of Padua (I)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quovadis Associazione', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera di Padova', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}