Assessment of Efficacy and Safety of Tocilizumab Compared to DefeROxamine, Associated With Standards Treatments in COVID-19 (+) Patients Hospitalized In Intensive Care in Tunisia
TRONCHER
1 other identifier
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Sep 2020
Shorter than P25 for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
September 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2020
CompletedAugust 27, 2020
August 1, 2020
Same day
April 22, 2020
August 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the mortality rate
* Evaluate the mortality rate at 90 days. * Evaluate the Intensive Care Unit (ICU) and Hospital Mortality rate at day 90 with date and cause of death (if applicable)
90 day
Study Arms (2)
Tocilizumab
EXPERIMENTALROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
Deferoxamine
ACTIVE COMPARATORDESFERAL: 500 mg, powder, and solvent for IV solution
Interventions
Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abderrahmane Mami Hospitallead
- Eshmoun Clinical Research Centercollaborator
- Datametrixcollaborator
Study Sites (1)
Eshmoun Clinical Research Centre/ Hôpital Abderrahmane Mami-Ariana
Aryanah, Tunisia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of department
Study Record Dates
First Submitted
April 22, 2020
First Posted
April 24, 2020
Study Start
September 4, 2020
Primary Completion
September 4, 2020
Study Completion
October 4, 2020
Last Updated
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share