Clinical Study of Tetrandrine Tablets Adjuvant Treatment With COVID-19
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.
详细描述
Since December 2019, a number of cases of pneumonia infected with the new coronavirus have been found in wuhan, hubei province.Has now become a global epidemic of crisis.
After recent frontline anti-epidemic experience, the diagnostic and treatment specifications for new coronary pneumonia have been updated several times. In the latest country, "Specifications for the Diagnosis and Treatment of New Types of Coronary Pneumonia (Trial Version 6)", the traditional Chinese medicines have again emphasized For the treatment of patients, traditional Chinese medicine preparations such as Xuebijing and Qingfei Paidu Decoction have been recommended, but the introduction of anti-fibrosis related drugs is still lacking.Tetrandrine is a traditional Chinese medicine. Previous research has shown that it is an antagonist of calmodulin, has anti-tumor, anti-inflammatory effects, and can effectively inhibit fibroblasts, thereby inhibiting pulmonary fibrosis.The study is expected to treat patients with mild and severe neo-coronary pneumonia through standard treatment regimens in combination with tetrandrine tablets, thereby reducing the clinical progress of some patients, improving prognosis, reducing the incidence of pulmonary fibrosis during rehabilitation, and improving patients' quality of life.
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
- •Patients with mild and severe cases who have been diagnosed with new coronavirus pneumonia according to the "Pneumonitis Diagnosis and Treatment -
- •Plan for New Coronavirus Infection"
- •Age 18 to 75 years;
- •Sign the informed consent voluntarily.
排除标准
- •With active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, patients with chronic respiratory failure or other severe respiratory disease;
- •According to the "pneumonia diagnosis and treatment program for new coronavirus infection" (trial version 6), critically ill patients
- •With severe patients with disease of heart head blood-vessel, malignant arrhythmia, unstable angina, acute myocardial infarction and death, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.);
- •With severe liver and kidney diseases (severe liver disease refers to cirrhosis, portal hypertension and varices bleeding, severe kidney disease including dialysis, kidney transplantation);
- •Pregnant and lactating women;
- •Severe cognitive and mental disorders;
- •Clinical investigators who were participating in other interventions within 1 month prior to inclusion
研究组 & 干预措施
Tetrandrine Cohort
After the subjects were enrolled, they were given "Tetrandrine 60mg QD" for a course of 1 week(Take 6 days, stop using for 1 day)
干预措施: Tetrandrine (Drug)
结局指标
主要结局
Survival rate
时间窗: 12 weeks
Death event
次要结局
- body temperature(2 weeks)