Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05074758
Status:
UNKNOWN
Last Update Posted:
2022-01-19
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of the microVAScular Dysfunction in Covid-19 ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples citrated tubes blood samples EDTA tubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-17', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prognostic value of alveolar dead space', 'timeFrame': 'Up to 28 days', 'description': 'Recording the exhaled CO2 curve (side-stream capnography method) and volume curve, as determined by the mechanical ventilator, and computing the signals with the arterial CO2 partial pressure, reflecting the partial pressure of CO2 in the alveoli participating in gas exchanges), determined on arterial blood gas (ABG) sampling.'}], 'secondaryOutcomes': [{'measure': 'Prognostic value of the alveolar dead space (measured iteratively)', 'timeFrame': '20 days', 'description': 'To establish the link between alveolar dead-space values and Day 20 mortality'}, {'measure': 'Prognostic value of the alveolar dead space (measured iteratively)', 'timeFrame': '28 days', 'description': 'To establish the link between alveolar dead-space values and Day 20 mortality and Day-28 invasive ventilator-free days.'}, {'measure': 'Level of circulating endothelial cells', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of progenitor cells', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of circulating stem cells', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of endothelial proteomics', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of D-dimers', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of Willebrand Factor', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of components of the fibrinolytic system', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of fragments of plasminogen', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Level of the components of the NETs (Neutrophil Extracellular Traps)', 'timeFrame': 'Up to 28 days', 'description': 'To describe the biological parameters of endothelial damage and prognostic value'}, {'measure': 'Survival rate', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary biological markers', 'alveolar dead-space', 'circulating endothelial cells'], 'conditions': ['ARDS, Human', 'COVID-19 Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '32676824', 'type': 'BACKGROUND', 'citation': 'Diehl JL, Peron N, Chocron R, Debuc B, Guerot E, Hauw-Berlemont C, Hermann B, Augy JL, Younan R, Novara A, Langlais J, Khider L, Gendron N, Goudot G, Fagon JF, Mirault T, Smadja DM. Respiratory mechanics and gas exchanges in the early course of COVID-19 ARDS: a hypothesis-generating study. Ann Intensive Care. 2020 Jul 16;10(1):95. doi: 10.1186/s13613-020-00716-1.'}, {'pmid': '32437596', 'type': 'BACKGROUND', 'citation': 'Ackermann M, Verleden SE, Kuehnel M, Haverich A, Welte T, Laenger F, Vanstapel A, Werlein C, Stark H, Tzankov A, Li WW, Li VW, Mentzer SJ, Jonigk D. Pulmonary Vascular Endothelialitis, Thrombosis, and Angiogenesis in Covid-19. N Engl J Med. 2020 Jul 9;383(2):120-128. doi: 10.1056/NEJMoa2015432. Epub 2020 May 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary endpoint of this research is to establish that the alveolar dead space is significantly higher in patients with COVID-19 ARDS, compared to patients with non-COVID-19 ARDS.\n\nSecondarily, the investigators want to establish the prognostic value of the alveolar-dead space (measured iteratively) in patients with COVID-19 and non-COVID-19 ARDS, to establish the respective influences of the biological parameters of endothelial damage, of the biological parameters of coagulopathy, of the parameters set on the artificial ventilator on the value of the alveolar dead space; in ARDS patients with COVID-19 and non-COVID-19 ARDS, to establish the prognostic value of the laboratory parameters of endothelial damage and coagulopathy in patients with COVID-19 and non-COVID-19 ARDS.', 'detailedDescription': 'Endothelial damage and coagulation activation at the lung microvascular level may play an important role in the physiopathology of the COVID-19 ARDS. The project aims to prospectively investigate both bedside pulmonary physiological markers and biological markers of coagulopathy and endothelial dysfunction in COVID-19 and non-COVID-19 ARDS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate or severe ARDS linked or not with covid-19', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years old\n* Invasive mechanical ventilation in place for less than 48 hours\n* Severe or moderate ARDS (defined according to the Berlin classification)\n* Virological confirmation by PCR of SARS-CoV-2 infection (ARDS COVID-19)\n* Lack of virological confirmation by PCR of SARS-CoV-2 infection (ARDS not linked to COVID-19)\n* Patient information\n\nExclusion Criteria:\n\n* Massive pulmonary embolism\n* Chronic respiratory failure under long-term oxygen therapy\n* Dying patient'}, 'identificationModule': {'nctId': 'NCT05074758', 'acronym': 'VASCOV', 'briefTitle': 'Characterization of the microVAScular Dysfunction in Covid-19 ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Characterization of the microVAScular Dysfunction in COvid-19 ARDS', 'orgStudyIdInfo': {'id': 'APHP210693'}, 'secondaryIdInfos': [{'id': '2021-A01339-32', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et des produits de santé'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-COVID-19 ARDS patients', 'description': '20 patients with acute respiratory distress syndrome (ARDS) unrelated to COVID-19', 'interventionNames': ['Diagnostic Test: alveolar dead-space quantification', 'Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations', 'Diagnostic Test: Endothelial activation / endothelial senescence']}, {'label': 'COVID-19 ARDS patients', 'description': '20 patients with acute respiratory distress syndrome (ARDS) linked to COVID-19', 'interventionNames': ['Diagnostic Test: alveolar dead-space quantification', 'Diagnostic Test: Coagulation activation and impaired fibrinolysis explorations', 'Diagnostic Test: Endothelial activation / endothelial senescence']}], 'interventions': [{'name': 'alveolar dead-space quantification', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of alveolar dead-space based on volumetric capnography', 'armGroupLabels': ['COVID-19 ARDS patients', 'non-COVID-19 ARDS patients']}, {'name': 'Coagulation activation and impaired fibrinolysis explorations', 'type': 'DIAGNOSTIC_TEST', 'description': 'blood sampling:\n\n* Fibrinolytic components\n* NETs components\n* Elastase-derived fragments of proteins of interest', 'armGroupLabels': ['COVID-19 ARDS patients', 'non-COVID-19 ARDS patients']}, {'name': 'Endothelial activation / endothelial senescence', 'type': 'DIAGNOSTIC_TEST', 'description': 'circulating endothelial cells, E-selectin, endoglin, LVEF-A, LVEFR-2, Angiopoietin -1 and -2, cKit and SDF-1 Willebrand factor (activity, antigen, multimeric analysis )', 'armGroupLabels': ['COVID-19 ARDS patients', 'non-COVID-19 ARDS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diehl Jean-Luc, PhD', 'role': 'CONTACT'}], 'facility': 'Hôpital européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Josephine Braun, PhD', 'role': 'CONTACT', 'email': 'josephine.braun@aphp.fr', 'phone': '01 44 84 17 38'}], 'overallOfficials': [{'name': 'Jean-Luc Diehl, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'AP-HP, Hôpital Européen Georges Pompidou, Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Agency, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}