A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 160
- 试验地点
- 73
- 主要终点
- Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
研究概览
简要总结
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19).
The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of or need for hospitalization for the medical treatment of COVID-19
- •Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
- •Receiving dialysis or have known moderate to severe renal impairment
- •Suspected or confirmed concurrent active systemic infection other than COVID-19
- •History of hypersensitivity or other contraindication to any of the components of the study intervention
- •Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4
- •Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
- •Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total).
Weight ≥40 kg
- ≥12 to <18 years
- ≥6 to <12 years
干预措施: nirmatrelvir (Drug)
Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total).
Weight ≥40 kg
- ≥12 to <18 years
- ≥6 to <12 years
干预措施: ritonavir (Drug)
Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
干预措施: nirmatrelvir (Drug)
Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
干预措施: ritonavir (Drug)
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥2 to <6 years
干预措施: nirmatrelvir (Drug)
Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥2 to <6 years
干预措施: ritonavir (Drug)
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥1 month (≥28 days) to <2 years
干预措施: nirmatrelvir (Drug)
Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir
≥1 month (≥28 days) to <2 years
干预措施: ritonavir (Drug)
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month (<28 days) old
干预措施: nirmatrelvir (Drug)
Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month (<28 days) old
干预措施: ritonavir (Drug)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
时间窗: From Baseline up through Day 34
Incidence of Adverse Events (AEs) leading to discontinuations.
时间窗: From Baseline up through Day 34
Number of participants with change from Baseline in Vital Signs
时间窗: From Baseline up through Day 34
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
时间窗: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
时间窗: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, and 2 hours post dose
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
时间窗: From Baseline up through Day 34
次要结局
- Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time(Baseline, Day 5, 6, 10, 14 and 28)
- Proportion of participants with COVID-19 related hospitalization or death from any cause(From Baseline through Day 28)
- Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)(At baseline only for tablets and after each dose for powder formulation)