Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
Study NCT ID:
NCT04361032
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Abderrahmane Mami Hospital
Organization:
Study Overview
Official 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. Multicentric, Comparative, Randomized Study
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRONCHER
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.
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)
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: