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)
Drug: Tocilizumab Injection
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Other Name: ROACTEMRA
Drug: Deferoxamine
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Other Name: DESFERAL
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
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Ariana, Tunisia
Investigator: Chokri Jeribi, Dr
Contact: +21627870563
eshmouncompany@eshmoun.com.tn
Eshmoun Clinical Research Centre
0021627870563
eshmouncompany@eshmoun.com.tn
Chokri Jeribi, Dr
+21627870563