Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-25 @ 7:20 PM
Study NCT ID:
NCT04405869
Status:
UNKNOWN
Last Update Posted:
2020-05-29
First Post:
2020-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thromboembolic Events in Severe COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-05-25', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of incidence of thromboembolic events in patients with Sars-CoV-2', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Covid-19', 'Thrombosis', 'D-Dimers', 'Anticoagulation'], 'conditions': ['Pulmonary Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '33465342', 'type': 'DERIVED', 'citation': 'Tacquard C, Mansour A, Godon A, Godet J, Poissy J, Garrigue D, Kipnis E, Rym Hamada S, Mertes PM, Steib A, Ulliel-Roche M, Bouhemad B, Nguyen M, Reizine F, Gouin-Thibault I, Besse MC, Collercandy N, Mankikian S, Levy JH, Gruel Y, Albaladejo P, Susen S, Godier A; French Working Group on Perioperative Hemostasis. Impact of High-Dose Prophylactic Anticoagulation in Critically Ill Patients With COVID-19 Pneumonia. Chest. 2021 Jun;159(6):2417-2427. doi: 10.1016/j.chest.2021.01.017. Epub 2021 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a confirmed infection with the Sars-CoV-2 virus', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed infection with the Sars-CoV-2 virus (RT-PCR)\n* Hospitalization in Intensive Care Unit\n* Age over 18 years Old\n\nExclusion Criteria:\n\n* Refusal of the patient to participate in data collection'}, 'identificationModule': {'nctId': 'NCT04405869', 'acronym': 'COVICLOT', 'briefTitle': 'Thromboembolic Events in Severe COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France', 'orgStudyIdInfo': {'id': '7779'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles TACQUARD, MD', 'role': 'CONTACT', 'email': 'charlesambroise.tacquard@chru-strasbourg.fr', 'phone': '33 3 69 55 16 08'}, {'name': 'Annick STEIB, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Claude ROCHE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lea RYFFEL, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Isabelle GOUIN-THIBAULT, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandre MANSOUR, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandre GODON, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pierre ALBALADEJO, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne GODIER, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stephan MANKIKIAN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maxime NGUYEN SOENEN, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bélaïd BOUHEMAD, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sophie SUSEN, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Delphine GARRIGUE, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien POISSY, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric KIPNIS, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cécile AUBRON, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Charles TACQUARD, MD', 'role': 'CONTACT', 'email': 'charlesambroise.tacquard@chru-strasbourg.fr', 'phone': '33 3 69 55 16 08'}, {'name': 'Saïd CHAYER, PhD, HDR', 'role': 'CONTACT', 'email': 'said.chayer@chru-strasbourg.fr', 'phone': '33 3 88 11 66 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}