Back to resultsEfficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anluohuaxian
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Anluohuaxian
Eligibility Criteria
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.
Sites / Locations
- The Second People's Hospital of Fuyang
- Ezhou Central Hospital
- Huoshenshan Hospital of Wuhan
- Jinyintan Hospital of WuhanRecruiting
- Tongji Hospital of Huazhong University of Science and Technology
- West Hospital Union Hospital Huazhong University of Science and Technology
- Wuhan Pulmonary Hospital
- Zhongnan Hospital of Wuhan University
- Wenzhou Medical University Affiliated First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anluohuaxian combined with regular treatment group
regular treatment group
Arm Description
Anluohuaxian: 6g each time, twice a day
Outcomes
Primary Outcome Measures
Changes in high-resolution computer tomography of the lung
Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Change in 6-minute walking distance
Secondary Outcome Measures
Changes in compound physiological index
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.
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.
Changes in vital capacity of the lung
Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Full Information
NCT ID
NCT04334265
First Posted
April 1, 2020
Last Updated
April 22, 2020
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04334265
Brief Title
Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
Official Title
Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Anluohuaxian
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anluohuaxian combined with regular treatment group
Arm Type
Experimental
Arm Description
Anluohuaxian: 6g each time, twice a day
Arm Title
regular treatment group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Anluohuaxian
Intervention Description
6g each time, twice a day
Primary Outcome Measure Information:
Title
Changes in high-resolution computer tomography of the lung
Description
Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography
Time Frame
3 months
Title
Change in 6-minute walking distance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in compound physiological index
Time Frame
3 months
Title
Changes in the scores of the St. George's Hospital Respiratory Questionnaire
Description
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.
Time Frame
3 months
Title
Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores
Description
mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.
Time Frame
3 months
Title
Changes in vital capacity of the lung
Description
Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guiqiang Wang
Phone
13911405123
Email
john131212@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Zhao
Phone
13810765943
Email
zhaohong_pufh@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guiqiang Wang
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second People's Hospital of Fuyang
City
Fuyang
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianfeng Han
Phone
13955881280
Facility Name
Ezhou Central Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhua Yu
Phone
13908688619
Facility Name
Huoshenshan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibin Zhang
Phone
13911992121
Facility Name
Jinyintan Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingyu Zhang
Phone
13507117929
Facility Name
Tongji Hospital of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning
Phone
13971521450
Facility Name
West Hospital Union Hospital Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Zheng
Phone
18602724981
Facility Name
Wuhan Pulmonary Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianxiang Chen
Phone
18971570937
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenshun Cheng
Phone
13627288300
Facility Name
Wenzhou Medical University Affiliated First Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Chen
Phone
13505777281
12. IPD Sharing Statement
Citations:
PubMed Identifier
32513299
Citation
Zhang C, Li J, Wu Z, Wang H, Que C, Zhao H, Wang G. Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 8;21(1):495. doi: 10.1186/s13063-020-04399-8.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
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