Trial | NCT04361032  Report issue

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
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    260
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.
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 Started
Sep 04
2020
Anticipated
Primary Completion
Sep 04
2020
Anticipated
Study Completion
Oct 04
2020
Anticipated
Last Update
Aug 27
2020

Drug Tocilizumab Injection

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

  • Other names: ROACTEMRA

Drug Deferoxamine

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

  • Other names: DESFERAL

Tocilizumab Experimental

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

Deferoxamine Active Comparator

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

Criteria 

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
No Results Posted