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)
Primary Purpose
COVID19, Intensive Care Unit
Status
Unknown status
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Tocilizumab Injection
Deferoxamine
Sponsored by
About this trial
This is an interventional treatment trial for COVID19 focused on measuring Deferoxamine, Tocilizumab
Eligibility 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
Sites / Locations
- Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tocilizumab
Deferoxamine
Arm Description
ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
DESFERAL: 500 mg, powder, and solvent for IV solution
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04361032
First Posted
April 22, 2020
Last Updated
August 26, 2020
Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix
1. Study Identification
Unique Protocol Identification Number
NCT04361032
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
Acronym
TRONCHER
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2020 (Anticipated)
Primary Completion Date
September 4, 2020 (Anticipated)
Study Completion Date
October 4, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abderrahmane Mami Hospital
Collaborators
Eshmoun Clinical Research Center, Datametrix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, Intensive Care Unit
Keywords
Deferoxamine, Tocilizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
Arm Title
Deferoxamine
Arm Type
Active Comparator
Arm Description
DESFERAL: 500 mg, powder, and solvent for IV solution
Intervention Type
Drug
Intervention Name(s)
Tocilizumab Injection
Other Intervention Name(s)
ROACTEMRA
Intervention Description
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Intervention Type
Drug
Intervention Name(s)
Deferoxamine
Other Intervention Name(s)
DESFERAL
Intervention Description
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Primary Outcome Measure Information:
Title
the mortality rate
Description
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)
Time Frame
90 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eshmoun Clinical Research Centre
Phone
0021627870563
Email
eshmouncompany@eshmoun.com.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Chokri Jeribi, Dr
Phone
+21627870563
Facility Information:
Facility Name
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
City
Ariana
Country
Tunisia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chokri Jeribi, Dr
Phone
+21627870563
Email
eshmouncompany@eshmoun.com.tn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
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