* TOCILIZUMAB IN PEDIATRIC PATIENTS HOSPITALIZED WITH COVID-19
Research type
Research Study
Full title
A PHASE Ib, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB IN PEDIATRIC PATIENTS HOSPITALIZED WITH COVID-19
IRAS ID
1005702
Contact name
Petya Koleva
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-005332-27
Clinicaltrials.gov Identifier
Research summary
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by a virus. Although an increasing number of treatments are becoming available for adults, there are very limited treatment options developed for children, and vaccines have not yet been approved for use in children of all age groups (at the time the study was designed). Therefore, there is an urgent medical need for effective therapies for children and adolescents who are very unwell with COVID-19 and which requires them to be cared for in a hospital. Tocilizumab is a drug that has shown to be effective in adults hospitalised with COVID-19. While doctors know a lot about tocilizumab, the side effects and effectiveness of tocilizumab when used in children and adolescents with COVID-19 are unknown. This clinical trial is recruiting children and adolescents who have been hospitalised with COVID-19 and need treatment with additional oxygen. Participants can take part if they are under 18 years old and are receiving corticosteroids given systemically (e.g. by mouth or as an injection). The purpose of this clinical trial is to test the safety of tocilizumab in children and adolescents with COVID-19, given as an infusion into the vein, and to understand the way the body processes the drug. This trial will also start to look at how effective tocilizumab is for the treatment of COVID-19 in children and adolescents. The main clinical trial endpoints (the main results that are measured in the trial) are: to find out the levels of tocilizumab present in the participant’s blood over 28 days, and if anything affects the blood levels of the drug.
The other clinical trial endpoints include: how well a participant responds to tocilizumab treatment over 60 days; how tocilizumab affects a participant’s immune system; the number and seriousness of any side effects experienced by the participant over 60 days, and the relationship between the dose of tocilizumab and safety and other measures.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0397
Date of REC Opinion
20 Sep 2022
REC opinion
Further Information Favourable Opinion