Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19

Sponsor
Hospital Sao Domingos
Study ID
NCT04377503
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab 180 MG/ML — DRUG
    Tocilizumab 8 mg/kg diluted in 100 ml of saline administered in 60 minutes. The dose will be repeated after 12 hours.
  • Methylprednisolone Sodium Succinate — DRUG
    Patients will receive methylprednisolone at a dose of 1.5 mg / kg / day divided into 2 daily doses for 7 days. Then they will receive 1 mg / kg / day for another 7 days. Finally 0.5 mg / kg / day until 21 days of use

Study Details

This study compare the efficacy and safety of tocilizumab versus methylprednisolone in the cytokine release syndrome of patients with COVID-19

Key Dates

Start date
May 1, 2020
Status verified
May 2020
Primary completion
Aug 31, 2020
Completion
Nov 30, 2020

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Patients will receive Tocilizumab, 8 mg / kg diluted in 100 ml of saline and administered IV for 60 minutes. The dose will be repeated only once 12 hours after the first dose.
  • Active Comparator: Methylprednisolone
    Patients will receive methylprednisolone at a dose of 1.5 mg / kg / day divided into 2 daily doses for 7 days. Then they will receive 1 mg / kg / day for another 7 days in two daily doses. Finally 0.5 mg / kg / day for another 7 days.

Primary Outcome Measure

Patient clinical status 15 days after randomization [ Time Frame: 15 days after randomization ]

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