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 — DRUGTocilizumab 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
- 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: TocilizumabGroup that received tocilizumab (8mg/kg, maximum dose 800 mg, only once) while being admitted with severe COVID-19 pneumonia.
- Arm: Non-tocilizumabGroup 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
- Anaclara Murujosa, MD+5491157033547
- Diego H Giunta, MD, MPH, PhD+54 11 4959 0200