CTIS2023-503282-27-00进行中（未招募）1 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 - GS-US-611-6464
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
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 5.3.1. 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
研究者
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