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

Phase 3

• Conditions: COVID19; Intensive Care Unit
• Interventions: Drug: Tocilizumab Injection; Drug: Deferoxamine

• Registration Number: NCT04361032
• Lead Sponsor: Abderrahmane Mami Hospital

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)

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-27
• Study Start: 2020-09-04
• Primary Completion: 2020-09-04
• Study Completion: 2020-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tocilizumab	Tocilizumab Injection	ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
Deferoxamine	Deferoxamine	DESFERAL: 500 mg, powder, and solvent for IV solution

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana; 🇹🇳 Ariana, Tunisia