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)

Abderrahmane Mami Hospital

Status and phase: Unknown; Phase 3

Conditions: COVID19; Intensive Care Unit

Treatments: Drug: Deferoxamine; Drug: Tocilizumab Injection

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04361032

ECC2020-06

Details and patient eligibility

About

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.

Full 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)

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Tocilizumab

Experimental group

Description:

ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)

Treatment:

Drug: Tocilizumab Injection

Deferoxamine

Active Comparator group

Description:

DESFERAL: 500 mg, powder, and solvent for IV solution

Treatment:

Drug: Deferoxamine