COVID-19Phase 1NCT05164133
A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19
A Phase 1 study testing Tocilizumab in people with COVID-19, run by Hoffmann-La Roche at 25 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 25 sitesin 11 countries
- Study dates
- 10 Jun 2022to 27 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
25 sites in 11 countries.
25 sites in 11 countries
United States7 sites
The University of Chicago
Chicago, Illinois, 60637
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106-2624
UT Physicians - Pediatric Center - Texas Medical Center
Houston, Texas, 77030-3005
Reagan UCLA Medical Center
Los Angeles, California, 90095
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Central Michigan University College of Medicine
Mount Pleasant, Michigan, 48858-3803
University of Utah - PPDS
Salt Lake City, Utah, 84108-1287
Spain4 sites
Hospital Sant Joan de Deu - PIN; Unitat de Recerca - Farmacia
Esplugues de Llobregat, Barcelona, 08950
Hospital Infantil Universitario Niño Jesus; Sección de Neuropediatria
Madrid, 28009
Hospital Universitario 12 De Octubre
Madrid, 28041
Hospital Universitario La Paz - PPDS
Madrid, 28046
France3 sites
CHRU Montpellier; SMPEA Peyre Plantade Centre de Ressources Autisme
Montpellier, 34295
Hospital Necker
Paris, 75015
Assistance Publique Hopitaux de Paris
Val-de-Marne, 94275
Croatia2 sites
Klinika Za Djecje Bolesti Zagreb
Zagreb, 10000
University Hospital for Infection Diseases "Dr. Fran Mihaljevic" - PPDS
Zagreb, 10000
Germany2 sites
Uniklinik Köln
Cologne, 50937
Universitätsklinikum Ulm
Ulm, 89081
Italy2 sites
ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco
Lecco, Lombardy, 23900
IRCCS Ospedale Pediatrico Bambino Gesù - INCIPIT - PIN
Rome, Lazio, 00165
Brazil1 site
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090
Poland1 site
Szpital Kliniczny im Karola Jonschera Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu
Poznan, 60-572
United Kingdom1 site
Great North Childrens Hospital
Newcastle upon Tyne, NE1 4LP
About this study
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
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
- COVID-19
- Being tested
- Tocilizumab
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Participants will receive intravenous (IV) tocilizumab
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | 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. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of TCZ
Measured: Through Day 28
Maximum serum concentration (Cmax) of TCZ
Measured: Through Day 28
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
Measured: Days 0-28
Serum concentration on Day 28 (C day 28) of TCZ
Measured: Day 28
Clearance (CL) of TCZ
Measured: Through Day 28
Volume of distribution of TCZ
Measured: Through Day 28
Secondary outcomes (6)
Duration of 90% saturation of sIL-6R
Measured: Through Day 28
Concentration of IL-6
Measured: Through Day 60
Concentration of sIL-6R
Measured: Through Day 60
Concentration of C-reactive protein (CRP)
Measured: Through Day 60
Percentage of participants with adverse events
Measured: Up to 60 days
Percentage of participants with severe adverse events
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start10 Jun 2022
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164133
- Sponsor's protocol ID
- WA43811
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2021
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05164133
- Acronym / sponsor ID
- WA43811
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: TocilizumabParticipants 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabParticipants will receive intravenous (IV) tocilizumab | Drug | All Participants |
Primary outcome
Serum concentration of TCZ
Time frame: Through Day 28
Maximum serum concentration (Cmax) of TCZ
Time frame: Through Day 28
Area under the curve from Days 0-28 (AUC days 0-28) of TCZ
Time frame: Days 0-28
Serum concentration on Day 28 (C day 28) of TCZ
Time frame: Day 28
Clearance (CL) of TCZ
Time frame: Through Day 28
Volume of distribution of TCZ
Time frame: Through Day 28
6 secondary outcomes
Duration of 90% saturation of sIL-6R
Time frame: Through Day 28
Concentration of IL-6
Time frame: Through Day 60
Concentration of sIL-6R
Time frame: Through Day 60
Concentration of C-reactive protein (CRP)
Time frame: Through Day 60
Percentage of participants with adverse events
Time frame: Up to 60 days
Percentage of participants with severe adverse events
Time frame: Up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tocilizumab in people with COVID-19, run by Hoffmann-La Roche at 25 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Spain, France, Croatia, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of TCZ (time frame: Through Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.