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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 (TRONCHER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361032
Recruitment Status : Unknown
Verified August 2020 by Dr Jalila Ben Khelil, Abderrahmane Mami Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Eshmoun Clinical Research Center
Datametrix
Information provided by (Responsible Party):
Dr Jalila Ben Khelil, Abderrahmane Mami Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
COVID19 Intensive Care Unit Drug: Tocilizumab Injection Drug: Deferoxamine Phase 3

Detailed Description:

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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. Multicentric, Comparative, Randomized Study
Estimated Study Start Date : September 4, 2020
Estimated Primary Completion Date : September 4, 2020
Estimated Study Completion Date : October 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tocilizumab
ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
 Drug: Tocilizumab Injection
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Other Name: ROACTEMRA
Active Comparator: Deferoxamine
DESFERAL: 500 mg, powder, and solvent for IV solution
 Drug: Deferoxamine
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Other Name: DESFERAL


Outcome Measures
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Primary Outcome Measures :
  1. the mortality rate [ Time Frame: 90 day ]
    • 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361032


Contacts
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Contact: Eshmoun Clinical Research Centre 0021627870563 eshmouncompany@eshmoun.com.tn
Contact: Chokri Jeribi, Dr +21627870563

Locations
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Tunisia
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Ariana, Tunisia
Contact: Chokri Jeribi, Dr    +21627870563    eshmouncompany@eshmoun.com.tn   
Sponsors and Collaborators
Abderrahmane Mami Hospital
Eshmoun Clinical Research Center
Datametrix
More Information
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Responsible Party: Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital
ClinicalTrials.gov Identifier: NCT04361032    
Other Study ID Numbers: ECC2020-06
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Jalila Ben Khelil, Abderrahmane Mami Hospital:
Deferoxamine
Tocilizumab
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Deferoxamine
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action