Safety and Efficacy of Tocilizumab in Moderate to Severe COVID-19 With Inflammatory Markers

Sponsor
Beneficência Portuguesa de São Paulo
Study ID
NCT04403685
Phase
PHASE3
Status
Terminated

Conditions

  • COVID
  • Cytokine Release Syndrome
  • SARS Pneumonia

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.

Study Details

The trial evaluates the efficacy and safety of Tocilizumab, which rapidly reduces the inflammation process through inhibition of IL-6 in patients with moderate to severe COVID-19 with increased inflammatory markers. There will be two arms in the trial, one receiving the best supportive care, and the other receiving it plus tocilizumab. Patients will be followed until Day 29 after randomization.

Key Dates

Start date
May 8, 2020
Status verified
Aug 2020
Primary completion
Jul 8, 2020
Completion
Jul 21, 2020

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Single-dose tocilizumab of 8 mg/kg (maximum dose of 800mg). Best supportive care.
  • No Intervention: Control arm
    Best supportive care.

Primary Outcome Measure

Evaluation of clinical status [ Time Frame: Day 15 of the trial ]

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