Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
NCT ID: NCT04361032
Last Updated: 2020-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
260 participants
INTERVENTIONAL
2020-09-04
2020-10-04
Brief Summary
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Multicentric, comparative, randomized study.
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Detailed Description
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* Usual standard treatment\*
* 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)
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization
VERSUS
Arm 2:
* Usual standard treatment\*
* 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
* Enoxaparin (4000 IU X 2) per day for the duration of hospitalization
Usual standard treatment\*: according to the standard practices of each center, apart from the active molecules of the 2 arms and their therapeutic class)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tocilizumab
ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
Tocilizumab Injection
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Deferoxamine
DESFERAL: 500 mg, powder, and solvent for IV solution
Deferoxamine
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Interventions
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Tocilizumab Injection
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Deferoxamine
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient with acute respiratory deficiency
* Patient hospitalized in the intensive care unit
* Age \>18 years old
* Having given written consent for their participation in the study
Exclusion Criteria
* Severe/severe liver failure
* Dialysis patients
* Renal insufficiency (clearance\< 30ml/min/1.73m2)
* Allergy to deferoxamine
* Pregnant or breastfeeding woman
* Hypersensitivity to the active substance or any of the excipients of Tocilizumab
* A decrease in blood platelets with previous use of enoxaparin or another heparin drug,
* hemophilia and related diseases,
* stomach or duodenal ulcer
18 Years
80 Years
ALL
No
Sponsors
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Eshmoun Clinical Research Center
NETWORK
Datametrix
INDUSTRY
Abderrahmane Mami Hospital
OTHER
Responsible Party
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Dr Jalila Ben Khelil
Head of department
Locations
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Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Aryanah, , Tunisia
Countries
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Central Contacts
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Chokri Jeribi, Dr
Role: CONTACT
Facility Contacts
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Other Identifiers
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ECC2020-06
Identifier Type: -
Identifier Source: org_study_id
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