A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05164133
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Participants will receive intravenous (IV) tocilizumab

Study Details

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.

Key Dates

Start date
Jun 10, 2022
Status verified
Apr 2024
Primary completion
Mar 27, 2024
Completion
Mar 27, 2024

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Participants
    Participants who are hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation will receive a single dose of TCZ on Day 1, with the option to receive a second dose 8-24 hours later if clinically indicated.

Primary Outcome Measure

Serum concentration of TCZ [ Time Frame: Through Day 28 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Reagan UCLA Medical CenterLos AngelesCalifornia90095-
The University of ChicagoChicagoIllinois60637-
Central Michigan University College of MedicineMount PleasantMichigan48858-3803-
Feinstein Institute for Medical ResearchManhassetNew York11030-
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens HospitalClevelandOhio44106-2624-
UT Physicians - Pediatric Center - Texas Medical CenterHoustonTexas77030-3005-
University of Utah - PPDSSalt Lake CityUtah84108-1287-

Find similar trials in Los Angeles, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Reagan UCLA Medical Center· Los Angeles, CAThe University of Chicago· Chicago, ILCentral Michigan University College of Medicine· Mount Pleasant, MIFeinstein Institute for Medical Research· Manhasset, NYUniversity Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital· Cleveland, OHUT Physicians - Pediatric Center - Texas Medical Center· Houston, TX

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