A PHASE Ib, SINGLE-ARM, OPEN-LABEL STUDY EVALUATING THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB IN PEDIATRIC PATIENTS HOSPITALIZED WITH COVID-19 - N/A

F. Hoffmann-La Roche Ltd0 个研究点目标入组 30 人开始时间: 2022年6月29日最近更新: 2024年5月27日

试验速览

暂无简介。

•- Aged less than 18 years at the time of signing Informed Consent Form or Assent (if applicable)
•- Ability to comply with the study protocol, in the investigator's judgment
•- Hospitalized with COVID-19 confirmed per a positive polymerase chain reaction (PCR) of any specimen 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
•- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs during the treatment period and for 90 days after the final dose of TCZ
•- For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 60 days after the final dose of TCZ to avoid exposing the embryo
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- 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
•- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN) detected within 24 hours of screening
•Platelet count <50,000/µL at screening
•- Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 90 days after the final dose of TCZ
•- 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)
•- Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study

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