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TRONCHER: 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
Abderrahmane Mami Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04361032
Collaborator
Eshmoun Clinical Research Center (Other), Datametrix (Industry)
260
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Days)
263.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Sep 4, 2020
Anticipated Primary Completion Date :
Sep 4, 2020
Anticipated Study Completion Date :
Oct 4, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • DESFERAL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the mortality rate [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

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana Ariana Tunisia

    Sponsors and Collaborators

    • Abderrahmane Mami Hospital
    • Eshmoun Clinical Research Center
    • Datametrix

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Jalila Ben Khelil, Head of department, Abderrahmane Mami Hospital
    ClinicalTrials.gov Identifier:
    NCT04361032
    Other Study ID Numbers:
    • ECC2020-06
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Aug 27, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Head of department, Abderrahmane Mami Hospital
    Deferoxamine
    Tocilizumab
    Additional relevant MeSH terms:
    COVID-19
    Deferoxamine

    Study Results

    No Results Posted as of Aug 27, 2020