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
Study ID
NCT04361032
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 4, 2020
Status verified
Aug 2020
Primary completion
Sep 4, 2020
Completion
Oct 4, 2020

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    ROACTEMRA: (8mg/ kg per day) (1 injection per infusion)
  • Active Comparator: Deferoxamine
    DESFERAL: 500 mg, powder, and solvent for IV solution

Primary Outcome Measure

the mortality rate [ Time Frame: 90 day ]

Central Contacts

  • Eshmoun Clinical Research Centre
    0021627870563
    [email protected]
  • Chokri Jeribi, Dr
    +21627870563

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