EUCTR2020-001803-17-IT进行中（未招募）1 期
A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants from Birth to < 18 Years of Age with COVID-19 - Phase 2/3 study of Remdesivir in patients from birth to <18 years old with COVID-19
GILEAD SCIENCES INCORPORATED0 个研究点目标入组 52 人开始时间: 2020年8月10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
- 52
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
- •1) Willing and able to provide assent or a parent or legal guardian willing and able to provide written informed consent (participants < 18 years of age, where locally and nationally approved) prior to performing study procedures.
- •2) Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board [IRB] or independent ethics committee [IEC]).
- •a) Cohort 1: = 12 years to < 18 years of age and weight at screening = 40 kg
- •b) Cohorts 2-4: = 28 days to < 18 years of age and weight at screening =3 kg and < 40 kg
- •c) Cohort 5: = 14 days to <28 days of age, gestational age > 37 weeks and weight at screening = 2.5 kg
- •d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of = 2.5 kg
- •e) Cohort 7: 0 days to < 56 days of age, gestational age = 37 weeks and birth weight of = 1.5 kg
- •3) SARS-CoV-2 infection confirmed by PCR
- •4) Hospitalized and requiring medical care for COVID-19
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
- •2) ALT or AST > 5 X ULN
- •3) eGFR < 30 mL/min using Schwartz formula for participants = 1 year of age
- •4)Creatinine above thresholds as described in (see table in Page 27) Protocol for < 1 year of age
- •5) If < 28 days of age, any major congenital renal anomaly
- •6) If < 24 hours of age, Apgar score < 5 at 10 minutes
- •7) Known hypersensitivity to the study drug, the metabolites, or formulation excipient
研究者
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