← Back to Search

Monoclonal Antibodies

Tocilizumab for Pediatric COVID-19 Patients

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Receiving systemic corticosteroids at baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 days

Awards & highlights

Study Summary

This trial will test if tocilizumab, a drug used to treat other conditions, is effective and safe in treating pediatric patients hospitalized with COVID-19.

Who is the study for?

This trial is for children under 18 hospitalized with COVID-19, who need extra oxygen or mechanical breathing support and are already on steroids. They must have a confirmed case of COVID-19. Kids can't join if they're born premature, have severe allergies to Tocilizumab, other infections besides COVID-19, tuberculosis, MIS-C condition, recent use of certain drugs or are in another drug trial.Check my eligibility

What is being tested?

The study tests Tocilizumab's effects on pediatric patients with COVID-19 needing oxygen support or ventilation. It looks at how the body processes the drug and its preliminary effectiveness and safety in these young patients.See study design

What are the potential side effects?

Tocilizumab may cause side effects like allergic reactions during infusion, increased risk of infection due to immune system suppression, liver function changes, blood pressure variations and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need help breathing or my oxygen levels are below 93% without assistance.

Select...

I am currently taking corticosteroids.

Select...

I am hospitalized with COVID-19, confirmed by a positive test and chest imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve from Days 0-28 (AUC days 0-28) of TCZ

Clearance (CL) of TCZ

Maximum serum concentration (Cmax) of TCZ

+3 more

Secondary outcome measures

Concentration of C-reactive protein (CRP)

Concentration of IL-6

Concentration of sIL-6R

+3 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

Inpatient admission

fatigue

agranulocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Tocilizumab

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: All ParticipantsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,090,038 Total Patients Enrolled

8 Trials studying COVID-19

2,991 Patients Enrolled for COVID-19

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,910 Total Patients Enrolled

10 Trials studying COVID-19

3,749 Patients Enrolled for COVID-19

Media Library

Tocilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05164133 — Phase 1

COVID-19 Research Study Groups: All Participants

COVID-19 Clinical Trial 2023: Tocilizumab Highlights & Side Effects. Trial Name: NCT05164133 — Phase 1

Tocilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05164133 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered for the investigation so far?

"This clinical trial sponsored by Hoffmann-La Roche necessitates the enrollment of 30 suitable candidates. The research is taking place at University of Utah - PPDS in Salt Lake City, UT and Reagan UCLA Medical Center in Los Angeles, CA."

Answered by AI

What is the current scope of this investigative experiment?

"Across the US, there are 11 medical sites where patient recruitment is taking place. These include University of Utah - PPDS in Salt Lake City, Reagan UCLA Medical Center in Los Angeles, Central Michigan University College of Medicine in Mount Pleasant and 8 other locations."

Answered by AI

What maladies has tocilizumab been demonstrated to ameliorate?

"Tocilizumab is prescribed for the treatment of juvenile idiopathic arthritis, both polyarticular and systemic varieties, as well as cytokine release syndrome induced by car-t cell therapy."

Answered by AI

Are there any precedents of using Tocilizumab in medical experimentation?

"Tocilizumab was initially studied at Svendborg Hospital OUH in 2012 and there have been 220 clinical trials completed. Currently, 71 more studies are actively recruiting patients, with the majority of these taking place within Salt Lake City, Utah."

Answered by AI

Is it possible to join the current clinical trial?

"Affirmative. The information on clinicaltrials.gov demonstrates that recruitment for this medical experiment is still underway, having been initially published on June 10th 2022 and recently updated as of November 21st 2022. 30 participants must be sourced from 11 different sites to complete the trial's requirements."

Answered by AI

Does Tocilizumab pose any risk to patients in its utilization?

"Drawing from available information, our team has rated Tocilizumab's safety level at 1. This is because the phase of this trial suggests only minimal data on efficacy and safety exists."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05164133.

All > Covid 19 > Coronavirus