A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 17
- 主要终点
- Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
研究概览
简要总结
The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).
The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.
详细描述
Pediatric participants will be enrolled as follows:
- 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, gestational 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual or legal guardian willing and able to provide written informed consent prior to performing study procedures. Individuals will provide assent, if possible, in accordance with local requirements and investigator's discretion.
- •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
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
- •Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening.
- •Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19 per protocol.
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, intravenous remdesivir (RDV), monoclonal antibodies).
- •Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection < 4 months prior to screening.
- •Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 < 28 days or < 5 half-lives, whichever is longer, before enrollment.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Obeldesivir (ODV) 350 mg Twice Daily, Cohort 1: ≥ 6 Years to < 18 Years and Weight ≥ 40 kg
Participants received ODV tablets (350 mg twice daily) for 5 days.
干预措施: Obeldesivir (Drug)
ODV 175 mg Twice Daily, Cohort 2: ≥ 6 Years to < 18 Years and Weight ≥ 20 kg to < 40 kg
Participants received ODV tablets (175 mg twice daily) for 5 days.
干预措施: Obeldesivir (Drug)
结局指标
主要结局
Plasma Concentration of GS-441524, Metabolite of Obeldesivir (ODV)
时间窗: Day 3 (5 to 8 hours postdose) and Day 5 (predose and 15 minutes, 30 minutes, 1 hour, and 4 hours postdose)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
时间窗: First dose date up to Day 35
Treatment-emergent adverse events are defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug.
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
时间窗: First dose date up to Day 35
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days participants who permanently discontinued study drug.
次要结局
- Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35(First dose date up to Day 35)
- Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5(Baseline, Day 5)
- Percentage of Participants Who Require Supplemental Oxygen Support by Day 35(First dose date up to Day 35)
- Palatability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants(Day 5)
- Acceptability for Each Formulation as Measured by Questionnaire Responses Assessed by the Study Participants(Day 5)
- Percentage of Participants With Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35(First dose date up to Day 35)
- Percentage of Participants With COVID-19-Related Hospitalization or All-Cause Death by Day 35(First dose date up to Day 35)