Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-30 @ 2:16 PM
Study NCT ID:
NCT04361032
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D003676', 'term': 'Deferoxamine'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-10-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mortality rate', 'timeFrame': '90 day', 'description': '* Evaluate the mortality rate at 90 days.\n* Evaluate the Intensive Care Unit (ICU) and Hospital Mortality rate at day 90 with date and cause of death (if applicable)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deferoxamine', 'Tocilizumab'], 'conditions': ['COVID19', 'Intensive Care Unit']}, 'descriptionModule': {'briefSummary': 'Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, associated with standards treatments in COVID-19 (+) patients, Hospitalized In Intensive care in Tunisia.\n\nMulticentric, comparative, randomized study.', 'detailedDescription': 'Arm1 :\n\n* Usual standard treatment\\*\n* Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion) a second injection may be considered if necessary, but no more than 800 mg per day. Only on the 1st day (D0)\n* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization\n\nVERSUS\n\nArm 2:\n\n* Usual standard treatment\\*\n* Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution) by electric syringe 40 mg/kg/day 5day/7 without exceeding 5 g per day for 14 days\n* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization\n\nUsual standard treatment\\*: according to the standard practices of each center, apart from the active molecules of the 2 arms and their therapeutic class)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient confirmed COVID19 positive\n* Patient with acute respiratory deficiency\n* Patient hospitalized in the intensive care unit\n* Age \\>18 years old\n* Having given written consent for their participation in the study\n\nExclusion Criteria:\n\n* Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID\\_2Pro or COVID+PA studies)\n* Severe/severe liver failure\n* Dialysis patients\n* Renal insufficiency (clearance\\< 30ml/min/1.73m2)\n* Allergy to deferoxamine\n* Pregnant or breastfeeding woman\n* Hypersensitivity to the active substance or any of the excipients of Tocilizumab\n* A decrease in blood platelets with previous use of enoxaparin or another heparin drug,\n* hemophilia and related diseases,\n* stomach or duodenal ulcer'}, 'identificationModule': {'nctId': 'NCT04361032', 'acronym': 'TRONCHER', 'briefTitle': 'Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia', 'organization': {'class': 'OTHER', 'fullName': 'Abderrahmane Mami Hospital'}, 'officialTitle': 'Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia. Multicentric, Comparative, Randomized Study', 'orgStudyIdInfo': {'id': 'ECC2020-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab', 'description': 'ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)', 'interventionNames': ['Drug: Tocilizumab Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deferoxamine', 'description': 'DESFERAL: 500 mg, powder, and solvent for IV solution', 'interventionNames': ['Drug: Deferoxamine']}], 'interventions': [{'name': 'Tocilizumab Injection', 'type': 'DRUG', 'otherNames': ['ROACTEMRA'], 'description': 'Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)', 'armGroupLabels': ['Tocilizumab']}, {'name': 'Deferoxamine', 'type': 'DRUG', 'otherNames': ['DESFERAL'], 'description': 'Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)', 'armGroupLabels': ['Deferoxamine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aryanah', 'country': 'Tunisia', 'contacts': [{'name': 'Chokri Jeribi, Dr', 'role': 'CONTACT', 'email': 'eshmouncompany@eshmoun.com.tn', 'phone': '+21627870563'}], 'facility': 'Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana', 'geoPoint': {'lat': 36.86012, 'lon': 10.19337}}], 'centralContacts': [{'name': 'Eshmoun Clinical Research Centre', 'role': 'CONTACT', 'email': 'eshmouncompany@eshmoun.com.tn', 'phone': '0021627870563'}, {'name': 'Chokri Jeribi, Dr', 'role': 'CONTACT', 'phone': '+21627870563'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abderrahmane Mami Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eshmoun Clinical Research Center', 'class': 'NETWORK'}, {'name': 'Datametrix', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department', 'investigatorFullName': 'Dr Jalila Ben Khelil', 'investigatorAffiliation': 'Abderrahmane Mami Hospital'}}}}