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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05164133
Collaborator
(none)
30
Enrollment
14
Locations
1
Arm
6.8
Anticipated Duration (Months)
2.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ib, Single-Arm, Open-Label Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab in Pediatric Patients Hospitalized With COVID-19
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Jan 2, 2023
Anticipated Study Completion Date :
Jan 2, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Serum concentration of TCZ [Through Day 28]

  2. Maximum serum concentration (Cmax) of TCZ [Through Day 28]

  3. Area under the curve from Days 0-28 (AUC days 0-28) of TCZ [Days 0-28]

  4. Serum concentration on Day 28 (C day 28) of TCZ [Day 28]

  5. Clearance (CL) of TCZ [Through Day 28]

  6. Volume of distribution of TCZ [Through Day 28]

Secondary Outcome Measures

  1. Duration of 90% saturation of sIL-6R [Through Day 28]

  2. Concentration of IL-6 [Through Day 60]

  3. Concentration of sIL-6R [Through Day 60]

  4. Concentration of C-reactive protein (CRP) [Through Day 60]

  5. Percentage of participants with adverse events [Up to 60 days]

  6. Percentage of participants with severe adverse events [Up to 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children'S Hospital of Orange County Orange California United States 92868-3874
2 University of Florida Jacksonville Jacksonville Florida United States 32209
3 The University of Chicago Chicago Illinois United States 60637
4 Feinstein Institute for Medical Research Manhasset New York United States 11030
5 University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital Cleveland Ohio United States 44106-2624
6 UT Physicians - Pediatric Center - Texas Medical Center Houston Texas United States 77030-3005
7 Hospital Necker Paris France 75015
8 Assistance Publique Hopitaux de Paris Val-de-Marne France 94275
9 Hippokration Hospital Thessaloniki Greece 546 42
10 ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco Lecco Lombardia Italy 23900
11 Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia Esplugues de Llobregat Barcelona Spain 08950
12 Hospital Universitario La Paz - PPDS Barcelona Spain 8041
13 Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria Madrid Spain 28009
14 Hospital Universitario 12 De Octubre Madrid Spain 28041

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT05164133
Other Study ID Numbers:
  • WA43811
First Posted:
Dec 20, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 5, 2022