The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- Viral nucleic acid test negative conversion rate
研究概览
简要总结
To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.
详细描述
In clinical institutions that enroll corona virus disease 2019 patients whose nucleic acids changed from negative to positive, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, favipiravir group and regular treatment group. 210 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( favipiravir group): 1(regular treatment group).
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
- None
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
- •COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs has been negative for two consecutive times after treatment (sampling time interval of at least 24 hours);
- •The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits;
- •Voluntarily participate in research and sign informed consent.
排除标准
- •Those allergic to fapilavir;
- •Pregnant or lactating women;
- •Unstable liver, kidney, and heart diseases;
- •History of mental disorders, substance abuse or dependence;
- •Researchers consider it inappropriate to participate in research;
- •Participating in other clinical research.
研究组 & 干预措施
Favipiravir group
On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days.
干预措施: Favipiravir (Drug)
结局指标
主要结局
Viral nucleic acid test negative conversion rate
时间窗: 5 months
Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
次要结局
- Clinical cure rate(5 months)
研究者
Guiqiang Wang
Principal Investigator
Peking University First Hospital