Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Anluohuaxian


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anluohuaxian combined with regular treatment group<br>Anluohuaxian: 6g each time, twice a day | Drug: Anluohuaxian<br>* 6g each time, twice a day<br>|
| No Intervention: regular treatment group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in high-resolution computer tomography of the lung | Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography | 3 months | 
| Change in 6-minute walking distance |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in compound physiological index |  | 3 months | 
| Changes in the scores of the St. George's Hospital Respiratory Questionnaire | 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. | 3 months | 
| Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores | mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties. | 3 months | 
| Changes in vital capacity of the lung | Adult male vital capacity is about 3,500 ml and female is about 2,500 ml. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anluohuaxian