2023-503282-27-00已完成3 期
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524
研究概览
简要总结
To evaluate the plasma pharmacokinetic (PK) of Obeldesivir (ODV; GS-5245) in pediatric participants with COVID-19 To evaluate the safety and tolerability of ODV in pediatric participants with COVID-19
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant or legal guardian willing and able to provide written informed consent prior to performing study procedures. Participants 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 (where permitted according to local law and approved nationally and by relevant IRB or IEC): a) Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg b) Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg c) Cohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kg d) Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg e) Cohort 5: ≥ 14 days to < 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg f) Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg g) Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
- •SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
- •Initial onset of 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, including: a) obesity (body mass index > 95th percentile for age and sex) b) diabetes c) chronic lung disease (eg, asthma, interstitial lung disease) d) cardiac disease (eg, congenital heart disease) e) immunosuppressive disease or receipt of immunosuppressive therapies resulting in moderate or severe immunocompromise f) neurologic disorders (eg, epilepsy, convulsions, cerebral palsy) g) genetic conditions (eg, trisomy and other chromosomal abnormalities) h) medical complexity, including medical-related technological dependence that is not related to COVID-19 (eg, tracheostomy, positive pressure ventilation) i) other medical conditions that are deemed to be a risk factor by the investigator
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 RDV, monoclonal antibodies).
- •Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.3.
- •of the protocol
- •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.
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 (including influenza) that may interfere with the evaluation of response to the study intervention.
- •Any of the following abnormal laboratory results at screening: a. ALT ≥ 5 × ULN b. eGFR < 60 mL/min/1.73 m2 for ≥ 1 year of age c. Serum creatinine: > 2.0 mg/dL for < 48 hours of life; > 2 × ULN for age for ≥ 48 hours of life to 1 year of age (refer to table on page 35 of protocol)
- •Any major congenital renal anomaly for participants < 28 days of age.
- •Apgar score < 5 for participants < 24 hours of age.
- •Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
- •Positive pregnancy test prior to enrollment for female participants of childbearing potential
结局指标
主要结局
PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524
PK parameters (AUC0-12, Cmax, and Ctrough) for ODV metabolite, GS-441524
Incidence of treatment-emergent AEs by Day 35
Incidence of treatment-emergent AEs by Day 35
Incidence of treatment-emergent laboratory abnormalities by Day 35
Incidence of treatment-emergent laboratory abnormalities by Day 35
次要结局
- Time to sustained alleviation of targeted COVID-19 symptoms by Day 35
- Change from baseline in SARS-CoV-2 nasal swab viral load at Day 5
- Proportion of participants who require supplemental oxygen support (low flow oxygen, high flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation) by Day 35
- Assessment of palatability and acceptability scores of each formulation at Day 5
- Proportion of participants with concomitant use of medications other than remdesivir and ODV for treatment of COVID-19 by Day 35
- Proportion of participants with COVID-19-related hospitalization or all-cause death by Day 35
研究者
EU CT Support
Scientific
Gilead Sciences Inc.
研究点 (14)
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