NCT04261270Unknown3 期
A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Rate of comprehensive adverse outcome
研究概览
简要总结
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18~55 years old, unlimited gender.
- •Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
- •Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
- •Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose.
- •Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
- •Patients who voluntarily sign informed consent forms.
排除标准
- •1.2019-nCoV severe Pneumonia patients.
- •Meet the definition of severe pneumonia(Comply with any of the followings):
- •Respiratory distress ,RR≥30 bpm;
- •In a resting state:SPO2≤93%;
- •PaO2/ FiO2≤300mmHg.
- •2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment.
- •3.Severe liver disease(such as:the ChildPugh score≥C;AST > 5 times the upper limit).
- •4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.
- •5.Patients with definite contraindications in ritonavir tablets.
- •6.Female subjects were positive for the pregnancy test during the screening period.
- •7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)
研究组 & 干预措施
ASC09F+Oseltamivir
Experimental
干预措施: ASC09F+Oseltamivir (Drug)
Ritonavir+Oseltamivir
Experimental
干预措施: Ritonavir+Oseltamivir (Drug)
Oseltamivir
Experimental
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Rate of comprehensive adverse outcome
时间窗: 14 days
The definition of comprehensive adverse outcome is as follows: 1. SPO2≤93% without oxygen inhalation; 2. PaO2/FiO2≤300mmHg; 3. RR≥30 bpm without oxygen inhalation.
次要结局
- Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery(28 days)
- Time of clinical remission(28 days)
- Rate of no fever(14 days)
- Rate of no cough(14 days)
- Rate of no dyspnea(14 days)
- Rate of no need for oxygen inhalation(14 days)
- Rate of undetectable viral RNA(14 days)
- Rate of mechanical ventilation(28 days)
- Rate of ICU admission(28 days)
研究者
研究点 (1)
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