Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-26 @ 6:51 PM
Study NCT ID:
NCT04930757
Status:
UNKNOWN
Last Update Posted:
2021-06-18
First Post:
2021-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2021-05-14', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quantification of the systemic inflammatory response upon admission to the ICU.', 'timeFrame': 'Within 4 hours following the patient admission in Intensive Care Units (ICU).', 'description': 'Circulating levels of proinflammatory cytokines (IL-1bêta, IL-6, IL-8, TNFalpha, TGFbêta, IFNgamma, IL-17, IL-21, IL-22, IL-23, and IL-10) will be measured by Luminex and the levels of soluble adhesion molecules and in particular of soluble JAM-C and soluble mediators will be measured by ELISA'}], 'primaryOutcomes': [{'measure': 'Percentage of circulating neutrophils in reverse migration', 'timeFrame': 'Within 4 hours following the patient admission in Intensive Care Units (ICU).', 'description': 'Percentage of circulating neutrophils in reverse migration determined on a sample taken during the admission of COVID 19 patients to Intensive Care Units by flow cytometry: the samples will be incubated for 45 minutes with anti-human CXCR1, CD11c, CD11b, and CD62L antibodies. Erythrocytes will be lysed and fixed leukocytes will be analyzed by flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Analysis of neutrophils and platelets', 'timeFrame': 'Within 4 hours following the patient admission in Intensive Care Units (ICU).', 'description': 'The analysis of neutrophils and platelets, and of the inflammatory environment will be carried out on a sample taken on admission of patients to Intensive Care Units\n\n1. Phenotypic and functional analysis of neutrophils\n\n * Measurement of the oxidative explosion\n * Measurement of neutrophil apoptosis\n * Measurement of intravascular NETosis\n2. Analysis of platelet aggregation and activation\n\n * Quantification of the fraction of immature platelets (IPF)\n * Contribution of platelets to clot stiffness\n * ELISA assay of soluble platelet activation markers\n * Measurement of D-Dimers, von Willebrand factor, thrombin-antithrombin complex (TAT), α2-Plasmin-Plasmin-inhibitor'}, {'measure': 'SAPS II score', 'timeFrame': 'From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).', 'description': 'Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU.\n\nThe severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought.'}, {'measure': 'SOFA score', 'timeFrame': 'From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).', 'description': 'Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU.\n\nThe severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought.'}, {'measure': 'Mortality rate', 'timeFrame': '2 months', 'description': 'The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid19', 'Neutrophils', 'Platelet aggregation activation', 'Clinical scores', 'SAPS II ("simplified acute physiology")', 'SOFA ("Sequential Organ Failure Assessment")', 'Global respiratory and non-respiratory scores'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.', 'detailedDescription': 'This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.\n\nDesign:\n\nA multicentric (3 sites) clinical trial\n\nSample size :\n\n200 patients\n\nPopulation concerned:\n\nPatients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.\n\nDuration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top.\n\nNo interim analysis is planned. Analysis will be performed at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France)\n* With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab\n* informed and not opposed to participation in research\n* included within 4 hours following the paatient's admission\n\nExclusion Criteria:\n\n* Patients under guardianship / curatorship\n* Patients under AME"}, 'identificationModule': {'nctId': 'NCT04930757', 'acronym': 'NeutroVID', 'briefTitle': 'Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19', 'orgStudyIdInfo': {'id': 'APHP210061'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.', 'description': 'Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hafid AIT-OUFELLA, Professor', 'role': 'CONTACT', 'email': 'hafid.aitoufella@aphp.fr', 'phone': '01 49 28 23 15'}, {'name': 'Carole ELBIM, Doctor', 'role': 'CONTACT', 'email': 'carole.elbim@sorbonne-universite.fr', 'phone': '06 60 80 85 98'}], 'facility': 'Intensive care department, Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Hafid AIT-OUFELLA, Professor', 'role': 'CONTACT', 'email': 'hafid.aitoufella@aphp.fr', 'phone': '01 49 28 23 15'}, {'name': 'Carole ELBIM, Doctor', 'role': 'CONTACT', 'email': 'carole.elbim@sorbonne-universite.fr', 'phone': '06 60 80 85 98'}], 'overallOfficials': [{'name': 'Hafid AIT-OUFELLA, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}