Safety and Effectiveness Study of Tocilizumab in Patients With Severe COVID-19

Sponsor
Hospital Italiano de Buenos Aires
Study ID
NCT04924829
Status
Unknown

Conditions

  • Severe COVID 19 Pneumonia
  • Tocilizumab

Eligibility Criteria

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

Interventions

  • Tocilizumab — DRUG
    Tocilizumab received as a single intravenous infusion over the period of 60 minutes. Dose of 8 mg/kg, maximum dose of 800 mg.

Study Details

Retrospective observational cohort study to evaluate the safety and effectiveness of tocilizumab in the treatment of severe COVID-19 pneumonia

Key Dates

First listed
Jun 14, 2021
Start date
Jun 1, 2021
Status verified
Jun 2021
Primary completion
Jul 1, 2021
Completion
Aug 1, 2021

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Tocilizumab
    Group that received tocilizumab (8mg/kg, maximum dose 800 mg, only once) while being admitted with severe COVID-19 pneumonia.
  • Arm: Non-tocilizumab
    Group that did not receive tocilizumab but share the same indication according to the elegibility criteria for it as the tocilizumab group while admitted with severe COVID-19 pneumonia.

Primary Outcome Measure

28-day mortality [ Time Frame: 28 days from hospital admission ]

Central Contacts