Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Pulmonary Fibrosis Due to 2019-nCoV Pneumonia With Fuzheng Huayu

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: NCT04279197
Recruitment Status : Recruiting
First Posted : February 21, 2020
Last Update Posted : February 21, 2020
Sponsor:
Collaborators:
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People’s Hospital
Tongji Hospital
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital

Brief Summary:
Inflammation is the early stage of fibrosis. Serious patients are more likely to develop into pulmonary fibrosis, which affects the recurrence of lung function or even threatens life and health. This study is planned to observe the efficacy and safety of Fuzheng Huayu tablets in the treatment of pulmonary fibrosis after COVID-19.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Due to 2019-nCoV Drug: N-acetylcysteine+ Fuzheng Huayu Tablet Drug: N-acetylcysteine+Placebo Phase 2

Detailed Description:

Corona Virus Disease 2019, which began in December 2019 in Wuhan, Hubei province, has spread rapidly and become an international public health emergency. Although the pathological mechanism of the pneumonia is unclear, some patients developed severe or critical condition due to the continuous development of inflammation.

Inflammation is the early stage of fibrosis. After the control of acute symptoms and signs, severe patients often have more manifestations of pulmonary fibrosis, which affects the recurrence of lung function. Fuzheng Huayu tablets has been proved effective in inhibiting MMP activity to protect subepithelial basement membrane which plays a key role in lung injury and interstitial fibrosis.

This is a randomized, double blind, multicenter clinical study of pulmonary fibrosis due to 2019-nCoV. The main objective is to evaluate the safety and efficacy of Fuzheng Huayu in pulmonary fibrosis after 2019-nCoV infection.

In this study, 136 eligible patients with pulmonary fibrosis due to 2019-nCoV infection will be randomly assigned to one of two treatment groups at a 1:1 ratio. Patients will receive one of two treatment regimens: A. Fuzheng Huayu tablets + basic treatment; B. Placebo tablets + basic treatment. The basic treatment includes N-acetylcysteine 1 capsule three times a day.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Multi-Center Study on the Efficacy and Safety of Fuzheng Huayu on Pulmonary Fibrosis Due to 2019-nCoV
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Basic Treatment+Fuzheng Huayu Tablet
Capcule with N-acetylcysteine+ Tablet with Fuzheng Huayu
Drug: N-acetylcysteine+ Fuzheng Huayu Tablet
The subjects will be taking 1 N-acetylcysteine capcule and 4 Fuzheng Huayu tablets three times a day for 24 weeks.

Placebo Comparator: Basic Treatment+Placebo
Capcule with N-acetylcysteine+ Tablet with starch
Drug: N-acetylcysteine+Placebo
The subjects will be taking 1 N-acetylcysteine capcule and 4 Placebo tablets three times a day for 24 weeks.




Primary Outcome Measures :
  1. High-resolution computed tomography (HRCT) score [ Time Frame: Week 24 ]
    Evaluation of Pulmonary fibrosis Improvement. HRCT images are graded from 1 to 6, higher scores mean a worse outcome.

  2. Lung function including FVC, FVC as a percentage of projected value and DLco [ Time Frame: Week 24 ]
    Evaluation of Lung Function Improvement


Secondary Outcome Measures :
  1. Times of acute exacerbation [ Time Frame: Week 24 ]
    Times of acute exacerbations during treatment

  2. Six-minute walk distance [ Time Frame: Week 24 ]
    Measured by a 6-minute walking test

  3. Dyspnea Scores [ Time Frame: Week 24 ]
    Using the scale revised by British modified Medical Research Council (MMRC) which divided patients into five degrees.Higher scores mean a worse outcome.

  4. Composite physiological index [ Time Frame: Week 24 ]
    Evaluation of Pulmonary fibrosis Improvement on CT which is calculated by formula.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with pulmonary fibrosis after standard treatment of COVID-19
  • Age 18-65
  • 2019-nCoV nucleic acid negative in respiratory tract or blood samples were detected by real-time fluorescence PCR for more than 2 times
  • The patient did not participant in other drug clinical studies within 1 month.
  • The patient or the patient's guardian agrees to participate the trial and sign the informed Consent Form

Exclusion Criteria:

  • Gestation or lactation period women and women who plan to get pregnant during the study period
  • Those who are unable to communicate, such as patients in unconsciousness or with dementia, various mental , etc.
  • Severe background disease like severe cardiac insufficiency (cardiac function grade IV), severe liver and kidney diseases, bronchial asthma, COPD, neurological diseases, tumors,etc.
  • Long-term bedridden for various reasons
  • Patient who are allergy to the experimental drug

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): NCT04279197


Contacts
Layout table for location contacts
Contact: Chenghai Liu, PhD 8621-20256521 chenghailiu@hotmail.com

Locations
Layout table for location information
China, Shanghai
Shuguang Hospital Recruiting
Shanghai, Shanghai, China, 201203
Contact: Chenghai Liu, PhD         
Sponsors and Collaborators
ShuGuang Hospital
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People’s Hospital
Tongji Hospital
Layout table for additonal information
Responsible Party: Liu Chenghai, Institute Director, ShuGuang Hospital
ClinicalTrials.gov Identifier: NCT04279197    
Other Study ID Numbers: Fzhy-ncp-2
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes