NCT05074420终止3 期
A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients From 1 Year to Less Than 18 Years Old Hospitalized With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 25
- 主要终点
- Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
研究概览
简要总结
The purpose for this study is to determine if the study drug baricitinib is effective and safe in hospitalized pediatric participants with Coronavirus disease 2019 (COVID -19) and to confirm the dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized with coronavirus (SARS-CoV-2) infection.
- •Male or female participants from 1 to <18 years of age.
- •Requires supplemental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment.
- •Supplemental oxygen including but not limited to: nasal cannula, mask, high flow devices, CPAP/BiPAP, invasive mechanical ventilation as well as ECMO.
排除标准
- •Are receiving biologic treatments (such as Tumor Necrosis Factor [TNF] inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferon, or Janus kinase (JAK) inhibitors); 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 Organic Anion Transporter 3 (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 non-live (inactivated) vaccinations are 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 a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or considered high risk of VTE (DVT/PE).
- •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) (Modification of Diet in Renal Disease [MDRD]) <40 milliliter/minute/1.73 meters squared.
- •Have a known hypersensitivity to baricitinib or any of its excipients.
- •Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. Note: The participant should not be enrolled (started) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day
- •Are pregnant, or intend to become pregnant or breastfeed during the study.
- •Are, in the opinion of the investigator or sponsor, at risk of immunosuppression or otherwise unsuitable for inclusion in the study.
- •Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
- •Are, in the opinion of the investigator, unlikely to survive for at least 48 hours after screening.
研究组 & 干预措施
Baricitinib QD
Experimental
- Participants received baricitinib as an oral suspension (2 milligrams per milliliter [mg/mL]) administered once daily (QD), with age group-based dosing: 4 milligrams (mg) for participants aged 10 to <18 years and up to 2 mg for those aged 1 to <10 years.
- Treatment was administered for up to 14 days or until hospital discharge, whichever occurred first, with follow-up assessments through approximately Day 60.
干预措施: Baricitinib (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib
时间窗: Day 1 and Day 4
PK: AUC of Baricitinib in pediatric participants with COVID-19
PK: Maximum Concentration (Cmax) of Baricitinib
时间窗: Day 1 and Day 4
PK: Cmax of Baricitinib in pediatric participants with COVID-19
Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC) of Baricitinib
时间窗: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
PK: Overall AUC of Baricitinib in pediatric participants with COVID-19. Summarized data were reported in this outcome measure.
PK: Maximum Concentration (Cmax) of Baricitinib
时间窗: Day 1: 0.25, 0.5, 2-4 hours post-dose; Day 4: Pre-dose, 1, 6-10 hours post-dose
PK: Overall Cmax of Baricitinib in pediatric participants with COVID-19. Summarized data were reported in this outcome measure.
次要结局
- Percentage of Participants Who Require Noninvasive Ventilation/high-flow oxygen or Invasive Mechanical Ventilation (including extracorporeal membrane oxygenation [ECMO])(Day 1 to Day 28)
- Percentage of Participants with at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge from Hospital(Day 4, Day 7, Day 10, Day 14, and Day 28)
- Overall improvement on the NIAID-OS(Day 4, Day 7, Day 10, Day 14, and Day 28)
- All-Cause Mortality(Day 1 to Day 28 and Day 60)
- Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (including ECMO)(Day 1 to Day 28)
- Number of Ventilator-Free Days(Day 1 to Day 28)
- Time to Recovery(Day 1 to Day 28)
- Duration of Hospitalization(Day 1 to Day 28)
- Duration of Stay in the Intensive Care Unit (ICU) in Days(Day 1 to Day 28)
- Percentage of Participants Who Progressed to Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO]) by Day 28(Day 1 to Day 28)
- Percentage of Participants Who Died or Progressed to Non-Invasive Ventilation/High-Flow Oxygen, Invasive Mechanical Ventilation, or ECMO by Day 28(Day 1 to Day 28)
- Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital(Day 4, Day 7, Day 10, Day 14, and Day 28)
- Number of Ventilator-Free Days (Days Free of Invasive Mechanical Ventilation)(Day 1 to Day 28)
- Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4(Day 4)
- Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7(Day 7)
- Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10(Day 10)
- Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14(Day 14)
- Percentage of Participants With Overall Improvement in the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 28(Day 28)
- All-Cause Mortality(Baseline (Day 1) up to end of follow-up (up to Day 60))
研究者
研究点 (25)
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