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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334265
• Other study ID #: 2020 research 110
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2020
• Source: Peking University First Hospital
• Contact: Guiqiang Wang
• Phone: 13911405123
• Email: john131212[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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-?, and traditional Chinese medicine;

6. Researchers consider it inappropriate to participate in research;

7. Participating in other clinical research.

Related Conditions & MeSH terms

• COVID-19
• Virus Diseases

Intervention

Drug:
• Anluohuaxian
6g each time, twice a day

Locations

Country	Name	City	State
China	The Second People's Hospital of Fuyang	Fuyang	Anhui
China	Wenzhou Medical University Affiliated First Hospital	Wenzhou	Zhejiang
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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in 6-minute walking distance		3 months
Secondary	Changes in compound physiological index		3 months
Secondary	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
Secondary	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
Secondary	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