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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

Tracking Information
First Submitted Date  ICMJE April 1, 2020
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date April 24, 2020
Actual Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • 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
  • Change in 6-minute walking distance [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2020)
  • Changes in compound physiological index [ Time Frame: 3 months ]
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
Official Title  ICMJE 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Anluohuaxian
6g each time, twice a day
Study Arms  ICMJE
  • Experimental: Anluohuaxian combined with regular treatment group
    Anluohuaxian: 6g each time, twice a day
    Intervention: Drug: Anluohuaxian
  • No Intervention: regular treatment group
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2020)
750
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guiqiang Wang 13911405123 john131212@sina.com
Contact: Hong Zhao 13810765943 zhaohong_pufh@bjmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334265
Other Study ID Numbers  ICMJE 2020 research 110
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guiqiang Wang, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Guiqiang Wang Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP