Tulane Research - Clinical Translational Unit

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

Purpose

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.

Condition

COVID-19

Eligibility

Eligible Ages: Under 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Hospitalized with COVID-19 confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, or other bodily fluid) and evidenced by chest x-ray or CT scan - Receiving systemic corticosteroids at baseline - Oxygen saturation < 93% on room air, or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) to maintain oxygen saturation > 92% at screening and baseline

Exclusion Criteria

Gestational age < 37 weeks - Known severe allergic reactions to TCZ or other monoclonal antibodies - Active tuberculosis infection - Uncontrolled active bacterial, fungal, viral, or other infection (besides COVID-19) - Diagnosis or suspected diagnosis of multisystem inflammatory syndrome in children (MIS-C) - In the opinion of the investigator, progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments - Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months prior to enrollment - Treatment with an investigational drug within 5 drug-elimination half-lives or 30 days, whichever is longer, of enrollment (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals) - Participating in another interventional drug clinical trial (except for anti-SARS-CoV-2 antibodies or directly-acting antivirals)

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	Drug: Tocilizumab Participants will receive intravenous (IV) tocilizumab

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: WA43811 https://forpatients.roche.com/
888-662-6728
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.