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)

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

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 Overview

• Status: Unknown
• Conditions: COVID19; Intensive Care Unit
• Intervention / Treatment: Drug: Tocilizumab Injection; Drug: Deferoxamine

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 Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Ariana, Tunisia
    • Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abderrahmane Mami Hospital
• Collaborators: Eshmoun Clinical Research Center; Datametrix

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 4, 2020
• Primary Completion (ANTICIPATED): September 4, 2020
• Study Completion (ANTICIPATED): October 4, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Tocilizumab; Deferoxamine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Siderophores; Deferoxamine
• Other Study ID Numbers: ECC2020-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No