Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-31 @ 4:44 AM
Study NCT ID:
NCT04609332
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Damage and Angiogenesis Biomarkers During COVID-19
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Syndecan-1 concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma Syndecan-1'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline ANG-2 concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma ANG-2'}, {'measure': 'Change from Baseline FGF basic concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma FGF basic'}, {'measure': 'Change from Baseline HGF concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma HGF'}, {'measure': 'Change from Baseline IL-8 concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma IL-8'}, {'measure': 'Change from Baseline PDGF-BB concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma PDGF-BB'}, {'measure': 'Change from Baseline TIMP-1 concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma TIMP-1'}, {'measure': 'Change from Baseline TIMP-2 concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma TIMP-2'}, {'measure': 'Change from Baseline TNFα concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma TNFα'}, {'measure': 'Change from Baseline VEGF concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma VEGF'}, {'measure': 'Change from Baseline Thrombomodulin concentration at 10th day', 'timeFrame': '24 Hours, 10 Days', 'description': 'Elevation of plasma Thrombomodulin'}, {'measure': 'Major cardiovascular events', 'timeFrame': '1 month, 3 months, 6 months 12 months.', 'description': 'Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Syndecan-1', 'Thrombomodulin', 'VEFG', 'ANG-2'], 'conditions': ['Covid19', 'Angiogenesis', 'Endothelial Dysfunction', 'Cardiovascular Morbidity']}, 'referencesModule': {'references': [{'pmid': '35372407', 'type': 'RESULT', 'citation': 'Maldonado F, Morales D, Diaz-Papapietro C, Valdes C, Fernandez C, Valls N, Lazo M, Espinoza C, Gonzalez R, Gutierrez R, Jara A, Romero C, Cerda O, Caceres M. Relationship Between Endothelial and Angiogenesis Biomarkers Envisage Mortality in a Prospective Cohort of COVID-19 Patients Requiring Respiratory Support. Front Med (Lausanne). 2022 Mar 16;9:826218. doi: 10.3389/fmed.2022.826218. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Severe SARS-CoV-2 disease is characterized by a progressive hypoxemic respiratory failure. Autopsies from these patients show severe endothelial damage with extensive vascular thrombosis, microangiopathy, and occlusion of alveolar capillaries and, finally, evidence of new vessel growth through intussusceptive angiogenesis.\n\nThis research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events.', 'detailedDescription': 'To study the presence of endothelial damage and angiogenic biomarkers with major cardiovascular events, the investigators will perform an observational study to evaluate plasma biomarkers concentrations in Covid-19 patients hospitalized in critical care units.\n\nAfter ethical review board approval, the investigators will select 40 patients admitted to intensive care units (ICU). After patient written consent or if the participants are unable to consent, after a relative subrogated acceptance, the investigators will collect blood samples in the first 24 hrs and on the 10th day of hospitalization.\n\nVenous blood samples are collected. After obtaining all samples, serum Syndecan-1, thrombomodulin, ANG-2, FGF basic, HGF, IL-8, PDGF-BB, TIMP-1, TIMP-2, TNFα y VEGF will be determined by a researcher blinded to the patient using commercially available Elisa kits. The concentration of each biomarker at each sample time will be compared. The investigators will observe clinical outcomes after one, 3, 6, and 12 months after the hospitalization.\n\nThe investigators found no previous data of this measurement in the COVID-19 scenario. In this observational study, the investigators select a sample size on convenience for the primary outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will include Covid 19 patients admitted to ICU with the need for oxygen and ventilatory support. Blood plasma biomarkers will be obtained on the first and 10th day of hospitalization. Information on major cardiac events will be obtained from the patient clinical file and by phone interview after hospitalization.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients older than 18 years\n2. Patient with a diagnosis of COVID-19 confirmed by PCR\n3. Patient with radiological image suggestive of COVID-19 with pending confirmation\n4. Need for ventilatory support with oxygen therapy by HFNC (High-flow nasal cannula)\n5. Need for invasive mechanical ventilation.\n\nExclusion Criteria:\n\n1. Patient with an image suggestive of COVID-19 with negative PCR\n2. Anticoagulation users before admission for any reason.'}, 'identificationModule': {'nctId': 'NCT04609332', 'briefTitle': 'Endothelial Damage and Angiogenesis Biomarkers During COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection', 'orgStudyIdInfo': {'id': 'OAIC 1164/20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endothelial damage and angiogenic biomarkers', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples for biomarkers study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380456', 'city': 'Independencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Clínico de la Universidad de Chile', 'geoPoint': {'lat': -33.41167, 'lon': -70.66647}}], 'overallOfficials': [{'name': 'Felipe Maldonado, M.D., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínico de la Universidad de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Felipe Andrés Maldonado Caniulao', 'investigatorAffiliation': 'University of Chile'}}}}