Clinical trial NCT04334265: 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
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Anluohuaxian
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Changes in high-resolution computer tomography of the lung
timeFrame: 3 months
measure: Change in 6-minute walking distance
timeFrame: 3 months
Secondary outcomes:
measure: Changes in compound physiological index
timeFrame: 3 months
measure: Changes in the scores of the St. George's Hospital Respiratory Questionnaire
timeFrame: 3 months
measure: Changes in modified British Medical Research Council Dyspnea Scale (mMRC) scores
timeFrame: 3 months
measure: Changes in vital capacity of the lung
timeFrame: 3 months
Other outcomes:
Locations:
city: Fuyang
country: China
facility: The Second People's Hospital of Fuyang
state: Anhui
city: Wuhan
country: China
facility: Ezhou Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Huoshenshan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Jinyintan Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital of Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: West Hospital Union Hospital Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan Pulmonary Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wenzhou
country: China
facility: Wenzhou Medical University Affiliated First Hospital
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Guiqiang Wang
role: PRINCIPAL_INVESTIGATOR
References:
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.