Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019
1 other identifier
interventional
750
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Apr 2020
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 24, 2020
April 1, 2020
2 months
April 1, 2020
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Change in 6-minute walking distance
3 months
Secondary Outcomes (4)
Changes in compound physiological index
3 months
Changes in the scores of the St. George's Hospital Respiratory Questionnaire
3 months
Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores
3 months
Changes in vital capacity of the lung
3 months
Study Arms (2)
Anluohuaxian combined with regular treatment group
EXPERIMENTALAnluohuaxian: 6g each time, twice a day
regular treatment group
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
The Second People's Hospital of Fuyang
Fuyang, Anhui, 230022, China
Ezhou Central Hospital
Wuhan, Hubei, 430000, China
Huoshenshan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Jinyintan Hospital of Wuhan
Wuhan, Hubei, 430000, China
Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
West Hospital Union Hospital Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Wuhan Pulmonary Hospital
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Wenzhou Medical University Affiliated First Hospital
Wenzhou, Zhejiang, 325000, China
Related Publications (1)
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.
PMID: 32513299DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guiqiang Wang
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 1, 2020
First Posted
April 6, 2020
Study Start
April 1, 2020
Primary Completion
June 1, 2020
Study Completion
December 1, 2020
Last Updated
April 24, 2020
Record last verified: 2020-04