EUCTR2021-001338-21-ES进行中（未招募）1 期
A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized withCOVID-19 - COV-BARRIER-PEDS
illy S.A.0 个研究点目标入组 24 人开始时间: 2021年8月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female patients from 1 to <18 years of age at the time of enrollment
- •- Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by NAAT or immunodiagnostic tests, with a positive result in a sample collected no more than 14 days prior to treatment assignment
- •- Require supplmental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •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
排除标准
- •- Are receiving biologic treatments (such as TNF inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferons, or JAK inhibitors) for any indication at study entry; or are receiving other immunosuppressants such that, in the opinion of the investigator, participating in the study would put the participant at an unacceptable risk of immunosuppression. Note: A washout period is required prior to screening.
- •- Are receiving strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.
- •- Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required)
- •- Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product
- •- Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: use of nonlive (inactivated) vaccinations is allowed for all participants
- •- Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry
- •- Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product
- •- Have any history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or are considered at high risk of VTE (DVT/PE) by the investigator
- •- Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry
- •- Have neutropenia (absolute neutrophil count < 1000 cells/microliters)
- •- Have lymphopenia (absolute lymphocyte count < 200 cells/microliters)
- •- Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times AAULN
- •- Estimated glomerular filtration rate (eGFR) <40 milliliter/minute/1.73 meters squared
研究者
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