A Multicenter, Open-Label, Randomized Phase 2a Study to Evaluate Safety and Efficacy of Ratutrelvir and Standard of Care in Non-hospitalized Symptomatic Adult Participants With Mild to Moderate COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 15
- 主要终点
- Safety based on adverse events incidence
研究概览
简要总结
This is an Early-stage Clinical Trial to Determine a Safe and Effective Dose for Ratutrelvir in Patients With Mild to Moderate COVID-19. It will also learn about the safety of drug Ratutrelvir. Participants will take a study drug as well as a standard therapy. A descriptive statistics will be used to present the study results.
详细描述
This is a multicenter, open-label, randomized Phase 2a study to evaluate the safety and efficacy of 83-0060 (Ratutrelvir) and Nirmatrelvir-Ritonavir (Paxlovid) in non-hospitalized symptomatic adult participants with mild to moderate COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed SARS-CoV-2 infection for 120 h prior to randomization.
- •Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to randomization.
- •At least one of the symptoms attributable to COVID-19 present within 24 hours prior to the Day 1 with the severity score of 1 or higher according to the following scoring system for the assessment of severity of:
排除标准
- •Medical Conditions:
- •History, current need for hospitalization or anticipated need for hospitalization for the medical treatment of COVID-
- •Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or ECMO.
- •Known medical history of active liver disease .
- •Receiving dialysis or history of moderate to severe renal impairment.
- •Compromised immune system.
- •Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease within 30 days before screening.
- •Suspected or confirmed concurrent active systemic infection..
- •Prior/Concomitant Therapy:
- •Has received or is expected to receive any dose of a SARS-CoV-2 vaccine within 4 months of screening and during the participation in the study.
- •Concomitant use of any medications or substances that are strong inducers of CYP3A4
研究组 & 干预措施
Ratutrelvir (83-0060)
干预措施: Ratutrelvir (83-0060) (Drug)
Paxlovid
Standard of care
干预措施: Paxlovid (Drug)
Ratutrelvir (83-0060) non-randomised
干预措施: Ratutrelvir (83-0060) non-randomised (Drug)
结局指标
主要结局
Safety based on adverse events incidence
时间窗: 28 days
Adverse events incidence will be described using descriptive statistics methods
Safety based on adverse events severity
时间窗: 28 days
Adverse events severity will be assessed by current version of CTCAE
次要结局
- PK characteristics of 83-0060 based on Maximum Plasma Concentration (Cmax)(11 days)
- PK characteristics of 83-0060 based on Area under the concentration time curve from 0 to time of last quantifiable concentration (AUClast)(11 days)
- PK characteristics of 83-0060 based on Time to Cmax ( Tmax)(11 days)
- Efficacy based on Time (days) to sustained recovery of all targeted COVID-19 signs/symptoms through Day 28(28 days)
- Efficacy based on Time to sustained recovery of each targeted COVID-19 symptom through Day 28.(28 days)