NCT04291053Unknown2 期
The Efficacy and Safety of Huai er in the Adjuvant Treatment of COVID-19: a Prospective, Multicenter, Randomized, Parallel Controlled Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 550
- 主要终点
- Mortality rate
研究概览
简要总结
In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world.There is no specific drug treatment for this disease. This study is planned to observe the efficacy and safety of Huaier granule in the adjuvant treatment 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
- 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 between 18 and 75 years, extremes included, male or female
- •Patients diagnosed with mild or common type COVID-19, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
- •patients can generally tolerable for treatment recommended by the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 6)"
- •Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc.,Eastern Cooperative Oncology Group score standard:0-1
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Female subjects who are pregnant or breastfeeding.
- •patients who are allergic to this medicine
- •patients meet the contraindications of Huaier granule
- •Patients with diabetes
- •Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
- •patients can't take drugs orally
研究组 & 干预措施
experimental group
Experimental
Standard therapy+Huaier granule Huaier granule 20g, po, tid for 2 weeks( or until discharge)
干预措施: Huaier Granule (Drug)
结局指标
主要结局
Mortality rate
时间窗: up to 28 days
All cause mortality
次要结局
- Duration (days) of mechanical ventilation(up to 28 days)
- The mean PaO2/FiO2(up to 28 days)
- Length of hospital stay (days)(up to 28 days)
- Length of ICU stay (days)(up to 28 days)
- Pulmonary function(up to 3 months after discharge)
- Clinical status assessed according to the official guideline(up to 28 days)
- The differences in oxygen intake methods(up to 28 days)
- Duration (days) of supplemental oxygenation(up to 28 days)
研究者
Chen Xiaoping
Principal Investigator
Tongji Hospital
相似试验
Unknown
2 期
Hydroxychloroquine and Nitazoxanide Combination Therapy for COVID-19COVID-19NCT04361318Tanta University100
Unknown
2 期
Escin in Patients With Covid-19 InfectionCoronavirus InfectionsNCT04322344University of Catanzaro120
已完成
不适用
Telerehabilitation in Individuals Over 65 Years of Age Having Social Isolation Due to Coronavirus (Covid-19)TelerehabilitationNCT04334434Kubra Koce, MSc PT30
Unknown
3 期
Traditional Chinese Medicine for Severe COVID-19COVID-19NCT04323332Xiyuan Hospital of China Academy of Chinese Medical Sciences50
Unknown
不适用
Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)COVID-19NCT04295551Jiangxi Qingfeng Pharmaceutical Co. Ltd.80