NCT04361032

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Abderrahmane Mami Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• COVID19
• Intensive Care Unit

Interventions

Type	Name	Description
DRUG	Tocilizumab Injection	Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
DRUG	Deferoxamine	Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)

Timeline

• Start date: 2020-09-04
• Primary completion: 2020-09-04
• Completion: 2020-10-04
• First posted: 2020-04-24
• Last updated: 2020-08-27

Locations

1 site across 1 country: Tunisia