NCT04345276已完成4 期
An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Huoshenshan Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Rate of composite adverse outcomes
研究概览
简要总结
Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.
详细描述
Given no specific antiviral therapies for COVID-19 approved yet and Danoprevir sodium tablet, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Danoprevir sodium tablet in hospitalized patients infected with SARS-CoV-2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years old;
- •Pneumonia patients with SARS-CoV-2 infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with SARS-CoV-2 infection (Current Trial Version);
- •Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
- •Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
- •Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
- •Patients who voluntarily sign informed consent.
排除标准
- •The pneumonia patients with severe SARS-CoV-2 infection met one of the following conditions: respiratory distress, RR≥30 times / min; or SaO2 / SpO2≤93% in resting state; or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) ≤300MMHG (1mmhg = 0.133kpa);
- •Pneumonia patients with severe SARS-CoV-2 infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
- •Severe liver disease (such as child Pugh score ≥C, AST > 5 times upper limit);
- •Patients with contraindications specified in the instructions of danoprevir and ritonavir tablets;
- •Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
- •The pregnancy test of female subjects in the screening period was positive;
- •The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
研究组 & 干预措施
Danoprevir+Ritonavir group
Experimental
干预措施: Danoprevir+Ritonavir (Drug)
结局指标
主要结局
Rate of composite adverse outcomes
时间窗: Within 10 days after administration
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen
次要结局
- Rate of ICU admission(Within 10 days after administration)
- Rate of serious adverse event(Within 10 days after administration)
- Rate of no dyspnea(Within 10 days after administration)
- Rate of mechanical ventilation(Within 10 days after administration)
- Rate of no cough(Within 10 days after administration)
- Rate of undetectable New coronavirus pathogen nucleic acid(Within 10 days after administration)
- Time to recovery(Within 10 days after administration)
- Rate of no fever(Within 10 days after administration)
- Rate of no requiring supplemental oxygen(Within 10 days after administration)
研究者
研究点 (1)
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