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

Unknown status
COVID-19

Drug: Anluohuaxian

6g each time, twice a day

Eligibility Criteria

Inclusion Criteria:

1. 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);

2. Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal
swabs during screening visits;

3. High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of
lobular septum, honeycomb-like changes, with or without bronchial / pleural
distraction);

4. Voluntarily participate in research and sign informed consent.

Exclusion Criteria:

1. 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;

2. Have been diagnosed with connective tissue disease;

3. Pregnant or lactating women;

4. History of mental disorders, substance abuse or dependence;

5. 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;

6. Researchers consider it inappropriate to participate in research;

7. Participating in other clinical research.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

The Second People's Hospital of Fuyang
Fuyang, Anhui, China

Ezhou Central Hospital
Wuhan, Hubei, China

Huoshenshan Hospital of Wuhan
Wuhan, Hubei, China

Jinyintan Hospital of Wuhan
Wuhan, Hubei, China

Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei, China

West Hospital Union Hospital Huazhong University of Science and Technology
Wuhan, Hubei, China

Wuhan Pulmonary Hospital
Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China

Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, China

Contacts

Guiqiang Wang
13911405123
john131212@sina.com

Hong Zhao
13810765943
zhaohong_pufh@bjmu.edu.cn

Guiqiang Wang, Principal Investigator
Peking University First Hospital

Peking University First Hospital
NCT Number
Keywords
Anluohuaxian
MeSH Terms
Virus Diseases
Coronavirus Infections
COVID-19