NCT04425772Unknown不适用
A Randomized,Double Blinded, Double Dummy, Parallel Controlled Clinical Trial for Azvudine in the Treatment of Novel Coronavirus Pneumonia (COVID-19）
HeNan Sincere Biotech Co., Ltd0 个研究点目标入组 342 人开始时间: 2020年6月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 342
- 主要终点
- Change (reduction) in viral load from baseline
研究概览
简要总结
To evaluate the efficacy and safety of azvudine in treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old, gender not limited;
- •Laboratory (RT-PCR) confirmed COVID-19;
- •the time from the first positive nucleic acid test to randomization does not exceed more than 4 days;
- •informed consent has been signed.
排除标准
- •known or suspected allergies to the components of azivudine tablets;
- •according to the latest version of the National Health and Medical Commission Diagnostic criteria of COVID-19, patients with severe novel coronavirus pneumonia was confirmed;
- •severe liver disease (TBIL>=2 times normal upper limit; ALTAST>=5 times normal upper limit);
- •subjects with severe renal insufficiency (glomerular filtration rate ≤60 mL/min/1.73 m2) or undergoing continuous renal replacement therapy, hemodialysis or peritoneal dialysis;
- •subjects with complication of malabsorption syndrome or any other condition affecting gastrointestinal absorption, requiring intravenous nutrition or not being able to take drugs orally;
- •subjectsis currently receiving anti-hiv treatment;
- •women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
- •participating in other clinical trials or using experimental drugs, except traditional Chinese medicine;
- •Other conditions that not appropriate to be enrolled into this study based on investigator's advise.
研究组 & 干预措施
Experimental Group
Experimental
FNC+Standard of Care
干预措施: FNC+Standard of Care (Drug)
Control Group
Placebo Comparator
FNC dummy tablet+ Standard of Care
干预措施: FNC dummy tablet+Standard of Care (Drug)
结局指标
主要结局
Change (reduction) in viral load from baseline
时间窗: On day 7 and 14
(reduction) in viral load from baseline
次要结局
- Frequency of adverse events(up to 21 days)
- proportion of subjects change from mild or moderate type to severe type(up to 21 days)
- proportion of subjects change from severe type to critical type(up to 21 days)
- time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.)(up to 21 days)
- novel coronavirus nucleic acid conversion rate(up to 21 days)
- Novel coronavirus nucleic acid negative conversion time(up to 21 days)
- Time and proportion of temperature return to normal(up to 21 days)
- time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms(up to 21 days)
- The time and proportion of improvement in pulmonary imaging(up to 21 days)
- Changes of blood oxygen detection index(up to 21 days)
- Frequency of requirement for supplemental oxygen or non-invasive ventilation(up to 21 days)
研究者
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