Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 750
- 试验地点
- 9
- 主要终点
- Change in 6-minute walking distance
研究概览
简要总结
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
详细描述
In clinical institutions that enroll patients with corona virus disease 2019, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, Anluohuaxian combined with regular treatment group and regular treatment group. 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( Anluohuaxian combined with regular treatment 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
- •Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);
- •Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;
- •High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);
- •Voluntarily participate in research and sign informed consent.
排除标准
- •Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;
- •Have been diagnosed with connective tissue disease;
- •Pregnant or lactating women;
- •History of mental disorders, substance abuse or dependence;
- •Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nidanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;
- •Researchers consider it inappropriate to participate in research;
- •Participating in other clinical research.
研究组 & 干预措施
Anluohuaxian combined with regular treatment group
Anluohuaxian: 6g each time, twice a day
干预措施: Anluohuaxian (Drug)
结局指标
主要结局
Change in 6-minute walking distance
时间窗: 3 months
Changes in high-resolution computer tomography of the lung
时间窗: 3 months
Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
次要结局
- Changes in compound physiological index(3 months)
- Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores(3 months)
- Changes in vital capacity of the lung(3 months)
- Changes in the scores of the St. George's Hospital Respiratory Questionnaire(3 months)
研究者
Guiqiang Wang
Principal Investigator
Peking University First Hospital