Evaluation of SSD8432 in Combination With Ritonavir in Asymptomatic Infections or Mild/Common Randomized, Double-blind, Safety Study of Efficacy and Safety in Adult Subjects With COVID-19 Placebo-Controlled, Phase II Clinical Study
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 主要终点
- Time to first nucleic acid turning negative
研究概览
简要总结
This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.
详细描述
This is a Randomized, double-blind, Placebo-Controlled, Phase II Clinical Study to evaluate SSD8432 in combination with Ritonavir in asymptomatic infections or mild/common safety study of efficacy and safety in adult subjects with COVID-19.
This study planned to enroll 72 subjects, randomly divided into low-dose group, high-dose group and placebo group according to 1:1:1.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 and ≤80 years old, male or female.
- •Asymptomatic infection,mild or common type of COVID-
- •Initial positive test of SARS-CoV-2 within 5 days of randomization.
- •Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
排除标准
- •Transnasal high-flow oxygen therapy or non-invasive ventilation, invasive mechanical ventilation, or ECMO is required or anticipated to be urgently required.
- •Prior to current disease episode, any confirmed SARS-CoV-2 infection.
- •Known medical history of active liver disease (other than nonalcoholic hepatic steatosis).
- •Receiving dialysis or have known moderate to severe renal impairment.
- •Known human immunodeficiency virus (HIV) infection.
- •Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
- •Oxygen saturation of ≤ 93% on room air obtained at rest within 24 hours prior to randomization..
- •Treatment with antivirals against SARS-CoV-2 within 14 days.
- •Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance.
- •Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 28 days.
- •Has received or is expected to receive COVID-19 monoclonal antibody, convalescent COVID-19 plasma or other prohibited concomitant medication.
- •Females who are pregnant or breastfeeding.
研究组 & 干预措施
SSD8432 300mg
SSD8432 300mg in combination with ritonavir 100mg
干预措施: SSD8432 300mg (Drug)
SSD8432 750mg
SSD8432 750mg in combination with ritonavir 100mg
干预措施: SSD8432 750mg (Drug)
SSD8432 placebo
SSD8432 placebo in combination with ritonavir placebo
干预措施: SSD8432Placebo (Drug)
结局指标
主要结局
Time to first nucleic acid turning negative
时间窗: Baseline through Day28
The time from the first administration to the first nucleic acid turning negative
次要结局
- Proportion of participants progressing to a worsening status(higher score)(Baseline through Day28)
- Maximum plasma concentration(Cmax)(Baseline through Day5)
- adverse events(Baseline through Day28)
- Time to Sustained Alleviation(baseline through Day28)
- viral load(Baseline through Day28)
- Resting oxygen saturation(Day1 and Day5)