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积极招募
奥贝德西韦治疗儿童和青少年COVID-19的研究
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简短的总结
本临床研究的目的是进一步了解奥贝德西韦(obeldesivir, ODV)治疗2019冠状病毒病(COVID-19)儿童和青少年的安全性和耐受性。.
主要目的是评估血浆药代动力学(PK)。, ODV在小儿COVID-19患者中的安全性和耐受性.
主要目的
Study Type
Phase
Eligibility
Gender
健康的志愿者
最低年龄
最高年龄
主要入选标准:
- 个人或法定监护人愿意并能够在进行研究程序之前提供书面知情同意. 个人将提供同意, 如果可能的话, 根据当地要求和调查员的判断.
- Aged < 18 years who meet one of the following weight criteria and gestational age (GA) criteria where applicable:
- Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg
- Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
- Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg
- Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg
- Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
- Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
- Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
- 筛查前≤5天经聚合酶链反应(PCR)或其他分子诊断试验确诊的严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)感染.
- 筛查前≤5天出现初发新冠肺炎体征/症状，且发热等体征/症状≥1个, cough, fatigue, 呼吸急促（气促）, 喉咙痛, headache, 筛查时出现肌痛/关节痛.
- 存在与COVID-19导致的严重疾病风险增加相关的≥1种特征或潜在疾病.
主要排除标准:
- Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness < 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, 静脉注射RDV, 单克隆抗体).
- Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection < 4 months prior to screening.
- 收到任何批准的, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, 哪个长一点, 入学前.
注:其他协议定义的纳入/排除标准可能适用.
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Study Stats
Protocol No.
23-001183
Category
传染病
儿科和产前疾病
首席研究员
Contact
Location
- 皇冠hga025大学洛杉矶分校韦斯特伍德