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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04361032

Acronym

TRONCHER

Enrollment

260

Registered

2020-04-24

Start date

2020-09-04

Completion date

2020-10-04

Last updated

2020-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID19, Intensive Care Unit

Keywords

Deferoxamine, Tocilizumab

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)

Interventions

DRUGTocilizumab Injection

Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)

DRUGDeferoxamine

Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Tunisia

Contacts

Primary ContactEshmoun Clinical Research Centre

eshmouncompany@eshmoun.com.tn0021627870563

Backup ContactChokri Jeribi, Dr

+21627870563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026