Status:
UNKNOWN
Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
Lead Sponsor:
Abderrahmane Mami Hospital
Collaborating Sponsors:
Eshmoun Clinical Research Center
Datametrix
Conditions:
COVID19
Intensive Care Unit
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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, comp...
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 1s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 4 2020
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04361032
Start Date
September 4 2020
End Date
October 4 2020
Last Update
August 27 2020
Active Locations (1)
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1
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Aryanah, Tunisia