Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
- Conditions
- COVID-19
- Interventions
- Drug: Anluohuaxian
- Registration Number
- NCT04334265
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 750
- 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.
- 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-Ξ³, and traditional Chinese medicine;
- Researchers consider it inappropriate to participate in research;
- Participating in other clinical research.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anluohuaxian combined with regular treatment group Anluohuaxian Anluohuaxian: 6g each time, twice a day
- Primary Outcome Measures
Name Time Method Change in 6-minute walking distance 3 months Changes in high-resolution computer tomography of the lung 3 months Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
- Secondary Outcome Measures
Name Time Method Changes in compound physiological index 3 months Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores 3 months mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Changes in vital capacity of the lung 3 months Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Changes in the scores of the St. George's Hospital Respiratory Questionnaire 3 months St. George's Hospital Respiratory Questionnaire range from 0 to 100. 0 stands for no impact on life and 100 stands for extreme impact on life.
Trial Locations
- Locations (9)
Huoshenshan Hospital of Wuhan
π¨π³Wuhan, Hubei, China
Wuhan Pulmonary Hospital
π¨π³Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
π¨π³Wuhan, Hubei, China
West Hospital Union Hospital Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Tongji Hospital of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
The Second People's Hospital of Fuyang
π¨π³Fuyang, Anhui, China
Ezhou Central Hospital
π¨π³Wuhan, Hubei, China
Jinyintan Hospital of Wuhan
π¨π³Wuhan, Hubei, China
Wenzhou Medical University Affiliated First Hospital
π¨π³Wenzhou, Zhejiang, China