Trials / Completed
CompletedNCT05164133
A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | Participants will receive intravenous (IV) tocilizumab |
Timeline
- Start date
- 2022-06-10
- Primary completion
- 2024-03-27
- Completion
- 2024-03-27
- First posted
- 2021-12-20
- Last updated
- 2024-04-29
Locations
25 sites across 11 countries: United States, Brazil, Croatia, France, Germany, Greece, Italy, Poland, South Africa, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05164133. Inclusion in this directory is not an endorsement.