Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia

Study Overview
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Brief Summary
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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.

Detailed Description
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Arm1 : 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)

Official Title
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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

Conditions
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COVID19, Intensive Care Unit

Intervention / Treatment
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* Drug: Tocilizumab Injection
* Drug: Deferoxamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient confirmed COVID19 positive 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: Taking Tocilizumab or hydroxychloroquine deferoxamine within one month prior to inclusion (excluding participation in THINC or COVID_2Pro or COVID+PA studies) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocilizumab<br>ROACTEMRA: (8mg/ kg per day) (1 injection per infusion) | Drug: Tocilizumab Injection<br>* Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)<br>* Other names: ROACTEMRA;|
| Active Comparator: Deferoxamine<br>DESFERAL: 500 mg, powder, and solvent for IV solution | Drug: Deferoxamine<br>* Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)<br>* Other names: DESFERAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the mortality rate | Evaluate the mortality rate at 90 days. Evaluate the Intensive Care Unit (ICU) and Hospital Mortality rate at day 90 with date and cause of death (if applicable) | 90 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deferoxamine, Tocilizumab