A Randomized, Double-blind, Placebo-controlled, Phase II/III Clinical Study Evaluating the Efficacy and Safety of SSD8432 in Combination With Ritonavir in Adult Subjects With Mild/Common COVID-19
试验速览
- 阶段
- 2 期
- 入组人数
- 670
- 主要终点
- Time to Sustained Alleviation
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19.
详细描述
This is a randomized, double-blind, placebo-controlled, phase II/III clinical study to evaluate the efficacy and safety of SSD8432 in combination with ritonavir in adult subjects with mild/common COVID-19.
This study plan to enroll 670 mild or common type adult COVID-19 subjects, Randomly assigned to the experimental group and the control group according to 1:1, experimental group:335subjects will receive SSD8432 and Ritonavir; control group :335subjects will receive SSD8432 placebo and Ritonavir placebo.
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.
- •Initial positive test of SARS-CoV-2 within 5 days of randomization.
- •mild or common type of COVID-
- •Initial onset of COVID-19 signs/symptoms within 3 days of randomization.
- •Fever or 1 respiratory symptom of COVID-19 on random day
- •Subjects without high risk factors
- •Subjects with at least one high-risk factor
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
Experimental group
SSD8432 750mg and Ritonavir 100mg
干预措施: SSD8432 750mg (Drug)
Control group
SSD8432 placebo and Ritonavir placebo
干预措施: SSD8432 placebo (Drug)
结局指标
主要结局
Time to Sustained Alleviation
时间窗: Baseline through Day28
Time to Sustained Alleviation of 5 COVID-19 signs/symptoms
Viral load
时间窗: Baseline through Day6
Change from baseline in viral load of SARS-CoV-2 in throat swabs by RT-PCR on Day 6 (after last dose)
次要结局
- Viral load(Baseline through Day28)
- Time to Sustained Alleviation(Baseline through Day28)
- Proportion of participants progress to a worsening status(higher score)(Baseline through Day28)
- Adverse events(Baseline through Day28)
- Maximum plasma concentration(Cmax)(Baseline through Day5)