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

Efficacy and Safety of Anluohuaxian in the Treatment of Rehabilitation Patients With Corona Virus Disease 2019-A Multicenter, Open, Randomized Controlled Study

To evaluate the efficacy and safety of Anluohuaxian in blocking the progression of pulmonary fibrosis and improving lung function in patients with COVID-19.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Anluohuaxian

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: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Fuyang, Anhui, China, 230022
      • Not yet recruiting
      • The Second People's Hospital of Fuyang
      • Contact: Xianfeng Han; Phone Number: 13955881280
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Jinyintan Hospital of Wuhan
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Ezhou Central Hospital
      • Contact: Junhua Yu; Phone Number: 13908688619
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Huoshenshan Hospital of Wuhan
      • Contact: Sibin Zhang; Phone Number: 13911992121
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Wuhan Pulmonary Hospital
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Zhongnan hospital of Wuhan University
      • Contact: Zhenshun Cheng; Phone Number: 13627288300
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • Tongji Hospital of Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430000
      • Not yet recruiting
      • West Hospital Union Hospital Huazhong University of Science and Technology
      • Contact: Xi Zheng; Phone Number: 18602724981
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • Not yet recruiting
      • Wenzhou Medical University Affiliated First Hospital
      • Contact: Yongping Chen; Phone Number: 13505777281

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in compound physiological index		3 months
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.	3 months
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.	3 months
Changes in vital capacity of the lung	Adult male vital capacity is about 3,500 ml and female is about 2,500 ml.	3 months

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Anluohuaxian
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Virus Diseases
• Other Study ID Numbers: 2020 research 110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No