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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334265
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Anluohuaxian Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Anluohuaxian combined with regular treatment group
Anluohuaxian: 6g each time, twice a day
Drug: Anluohuaxian
6g each time, twice a day

No Intervention: regular treatment group



Primary Outcome Measures :
  1. Changes in high-resolution computer tomography of the lung [ Time Frame: 3 months ]
    Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography

  2. Change in 6-minute walking distance [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Changes in compound physiological index [ Time Frame: 3 months ]
  2. Changes in the scores of the St. George's Hospital Respiratory Questionnaire [ Time Frame: 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.

  3. Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores [ Time Frame: 3 months ]
    mMRC score range from 0 to 4. 0 stands for wheezing only when exercising hard and 4 stands for severe breathing difficulties.

  4. Changes in vital capacity of the lung [ Time Frame: 3 months ]
    Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334265


Contacts
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Contact: Guiqiang Wang 13911405123 john131212@sina.com
Contact: Hong Zhao 13810765943 zhaohong_pufh@bjmu.edu.cn

Locations
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China, Anhui
The Second People's Hospital of Fuyang Not yet recruiting
Fuyang, Anhui, China, 230022
Contact: Xianfeng Han    13955881280      
China, Hubei
Ezhou Central Hospital Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Junhua Yu    13908688619      
Huoshenshan Hospital of Wuhan Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Sibin Zhang    13911992121      
Jinyintan Hospital of Wuhan Recruiting
Wuhan, Hubei, China, 430000
Contact: Dingyu Zhang    13507117929      
Tongji Hospital of Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Qin Ning    13971521450      
West Hospital Union Hospital Huazhong University of Science and Technology Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Xi Zheng    18602724981      
Wuhan Pulmonary Hospital Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Xianxiang Chen    18971570937      
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Zhenshun Cheng    13627288300      
China, Zhejiang
Wenzhou Medical University Affiliated First Hospital Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Yongping Chen    13505777281      
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Guiqiang Wang Peking University First Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guiqiang Wang, Principal Investigator, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT04334265    
Other Study ID Numbers: 2020 research 110
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guiqiang Wang, Peking University First Hospital:
Anluohuaxian
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections