A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
NCT05164133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2024-04-29
Summary
This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Conditions
Interventions
- DRUG
-
Participants will receive intravenous (IV) tocilizumab
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-10
- Primary Completion
- 2024-03-27
- Completion
- 2024-03-27
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Croatia
- France
- Germany
- Greece
- Italy
- Poland
- South Africa
- Spain
- United Kingdom
Study Locations
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