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

No results posted yet for this study

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

Tocilizumab

Participants will receive intravenous (IV) tocilizumab

Sponsors & Collaborators

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164133 on ClinicalTrials.gov