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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Participants will receive intravenous (IV) tocilizumab
Serum concentration of TCZ
Time frame: Through Day 28
Maximum serum concentration (Cmax) of TCZ
Time frame: Through Day 28
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
Time frame: Days 0-28
Serum concentration on Day 28 (C day 28) of TCZ
Time frame: Day 28
Clearance (CL) of TCZ
Time frame: Through Day 28
Volume of distribution of TCZ
Time frame: Through Day 28
Duration of 90% saturation of sIL-6R
Time frame: Through Day 28
Concentration of IL-6
Time frame: Through Day 60
Concentration of sIL-6R
Time frame: Through Day 60
Concentration of C-reactive protein (CRP)
Time frame: Through Day 60
Percentage of participants with adverse events
Time frame: Up to 60 days
Percentage of participants with severe adverse events
Time frame: Up to 60 days
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