Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT05128760
Status:
UNKNOWN
Last Update Posted:
2021-11-22
First Post:
2021-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2021-11-18', 'studyFirstSubmitQcDate': '2021-11-18', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of activated protein C resistance and comparison between groups', 'timeFrame': 'at inclusion'}], 'secondaryOutcomes': [{'measure': 'frequency of positivity of each aPL test and comparison between groups', 'timeFrame': 'at inclusion'}, {'measure': 'concentration of leucocytes activation markers and comparison between groups', 'timeFrame': 'at inclusion'}, {'measure': 'frequency of persistent aPL test positivity and comparison between groups', 'timeFrame': 'at three month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antiphospholipid Syndrome', 'COVID-19']}, 'referencesModule': {'references': [{'pmid': '32369280', 'type': 'BACKGROUND', 'citation': 'Bowles L, Platton S, Yartey N, Dave M, Lee K, Hart DP, MacDonald V, Green L, Sivapalaratnam S, Pasi KJ, MacCallum P. Lupus Anticoagulant and Abnormal Coagulation Tests in Patients with Covid-19. N Engl J Med. 2020 Jul 16;383(3):288-290. doi: 10.1056/NEJMc2013656. Epub 2020 May 5. No abstract available.'}, {'pmid': '32572467', 'type': 'BACKGROUND', 'citation': 'Zuily S, de Laat B, Guillemin F, Kelchtermans H, Magy-Bertrand N, Desmurs-Clavel H, Lambert M, Poindron V, de Maistre E, Dufrost V, Risse J, Shums Z, Norman GL, de Groot PG, Lacolley P, Lecompte T, Regnault V, Wahl D. Anti-Domain I beta2-Glycoprotein I Antibodies and Activated Protein C Resistance Predict Thrombosis in Antiphospholipid Syndrome: TAC(I)T Study. J Appl Lab Med. 2020 Nov 1;5(6):1242-1252. doi: 10.1093/jalm/jfaa072.'}, {'pmid': '26097119', 'type': 'BACKGROUND', 'citation': 'Yalavarthi S, Gould TJ, Rao AN, Mazza LF, Morris AE, Nunez-Alvarez C, Hernandez-Ramirez D, Bockenstedt PL, Liaw PC, Cabral AR, Knight JS. Release of neutrophil extracellular traps by neutrophils stimulated with antiphospholipid antibodies: a newly identified mechanism of thrombosis in the antiphospholipid syndrome. Arthritis Rheumatol. 2015 Nov;67(11):2990-3003. doi: 10.1002/art.39247.'}, {'pmid': '30616644', 'type': 'BACKGROUND', 'citation': 'Edel Y, Kliminski V, Pokroy-Shapira E, Oren S, Dortort Lazar A, Pri-Paz Basson Y, Egbaria M, Molad Y. Elevated plasma level of soluble triggering receptor expressed on myeloid cells-1 is associated with inflammation activity and is a potential biomarker of thrombosis in primary antiphospholipid syndrome. Arthritis Res Ther. 2019 Jan 7;21(1):10. doi: 10.1186/s13075-018-1779-5.'}]}, 'descriptionModule': {'briefSummary': 'Context: Until 70% of thrombotic event are reported during Sars-CoV2 infection. Antiphospholipid antibodies (aPL) tests are often positive. We aim to determine if aPL positivity is involved in thrombose of Sars-CoV2 infection investigating the effect of aPL on thrombin generation (TG) and leucocyte pathway activation (neutrophils extracellular traps (NETs) and activation of triggering receptor expressed on myeloid cells 1 (TREM-1)).\n\nMethod: We will compare plasma from five groups of subjects: patients with antiphospholipid syndrome (APS) and patients hospitalized for Sars-CoV-2 infection with or without aPL, and as control, patients with acute venous thromboembolism event and healthy volunteers. For each subject, we will analyze aPL, activated protein C (APC) resistance measured by TG and leukocytes markers as circulating neutrophils extracellular traps (NETs) and soluble triggering receptor expressed on myeloid cells one (sTREM-1). We will control aPL test at three month and analyze their persistent positivity and association with thrombotic event.\n\nResults: we hypothesize that patients with COVID-19 and aPL will have a similar aPL and level of APS resistance that patients with APS. Also, we think that circulating NETs and sTREM-1 levels will be more important in patients with COVID-19 with aPL than patients without aPL and similar in patients with COVID-19 and aPL and patients with APS.\n\nConclusion: our study will be the first to analyze the potential role of aPL on APC resistance measured by TG and neutrophil activation in COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Five groups of subjects will be enrolled in the study :\n\n1. patients hospitalized for à COVID-19 with aPL\n2. patients hospitalized for à COVID-19 without aPL\n3. patients with APS\n4. as control, patients with acute venous thromboembolism disease\n5. as control, healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient receiving a comprehensive information about the study, and not opposed to participate\n\n \\+ one criterion among :\n* patient hospitalized fo a COVID-19\n* Patient with known APS\n* Patients hospitalized for an acute venous thromboembolism event aPL positivity or COVID-19\n* healthy volunteers\n\nExclusion Criteria:\n\n* For all participants : pregnancy, age below 18 years-old, absence of written informed consent , autoimmune or inflammatory disease except antiphospholipid syndrome\n* For patients with COVID-19: previous aPL positivity (before COVID-19 infection)\n* For patients with APS: previous symptomatic COVID-19 infection\n* For patients control with acute venous thromboembolism event: previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of thromboembolism event, known aPL positivity\n* For Healthy volunteers: history of thrombosis (venous, arterial or small vessels), previous symptomatic COVID-19 infection, infection or inflammatory disease in flare at the time of inclusion, known aPL positivity'}, 'identificationModule': {'nctId': 'NCT05128760', 'acronym': 'TACIT2', 'briefTitle': 'Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection (TACIT2 Study)', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of Antiphospholipid Antibodies on Thrombin Generation During Sars-CoV2 Infection.', 'orgStudyIdInfo': {'id': '2021-A00244-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with COVID-19 and aPL positivity', 'description': 'Patient with COVID-19 and aPL test positivity', 'interventionNames': ['Diagnostic Test: characterization of aPL']}, {'label': 'Patients with COVID-19 without aPL positivity', 'interventionNames': ['Diagnostic Test: characterization of aPL']}, {'label': 'APS patients', 'interventionNames': ['Diagnostic Test: characterization of aPL']}, {'label': 'Healthy control', 'interventionNames': ['Diagnostic Test: characterization of aPL']}, {'label': 'Disease control', 'interventionNames': ['Diagnostic Test: characterization of aPL']}], 'interventions': [{'name': 'characterization of aPL', 'type': 'DIAGNOSTIC_TEST', 'description': 'characterization of aPL profile, GT profile and leukocytes activations markers (NETs, TREM-1)', 'armGroupLabels': ['APS patients', 'Disease control', 'Healthy control', 'Patients with COVID-19 and aPL positivity', 'Patients with COVID-19 without aPL positivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'Virginie Dufrost, MD', 'role': 'CONTACT'}, {'name': 'Stéphane Zuily, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Denis G Wahl, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Foret, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Virginie Dufrost', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Virginie DUFROST, MD', 'role': 'CONTACT', 'email': 'v.dufrost@chru-nancy.fr', 'phone': '+33383157828'}, {'name': 'Stephane Zuily, MD, PhD', 'role': 'CONTACT', 'email': 's.zuily@chru-nancy.fr', 'phone': '+33383157354'}], 'overallOfficials': [{'name': 'Denis G Wahl, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU of Nancy'}, {'name': 'Stéphane Zuily, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU of Nancy'}, {'name': 'Virginie Dufrost, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU of Nancy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Virginie Dufrost', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}