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Treatment of Pulmonary Fibrosis Due to COVID-19 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04279197
Recruitment Status : Completed
First Posted : February 21, 2020
Last Update Posted : January 3, 2022
Sponsor:
Collaborators:
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People's Hospital
Wuhan No.1 Hospital
Wuhan Third Hospital
Huangshi Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Liu Chenghai, ShuGuang Hospital

Brief Summary:
According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims 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 COVID-19 Drug: Fuzheng Huayu Tablet Drug: Vitamin C tablets Drug: Placebo Other: respiratory function rehabilitation training Phase 2

Detailed Description:

The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis induced by bleomycin in animals, and improve the pulmonary function in the patients with chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or pulmonary function injury in the recovery period of COVID-19 and expect to improve the prognosis.

This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls 142 patients who had been diagnosed with COVID-19, but currently they are negative for viral testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly assigned into Placebo group and FZHY group. All patients are given usual treatment such as respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng Huayu tablets, and the control group is given placebo. Each patient will be observed for 24 weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety disorder-7 (GAD-7) score. The safety also be observed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fuzheng Huayu Tablets in Post-COVID-19 Patients With Pulmonary Inflammation and Fibrosis : A Multicenter Double-blind Randomized Controlled Trial
Actual Study Start Date : April 23, 2020
Actual Primary Completion Date : March 24, 2021
Actual Study Completion Date : March 24, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FZHY Group

usual treatment (respiratory function rehabilitation training + Vitamin C tablets)

  • Fuzheng Huayu tablets
Drug: Fuzheng Huayu Tablet
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Other Name: FZHY

Drug: Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral;
Other Name: VC

Other: respiratory function rehabilitation training
Health exercise, once a day

Placebo Comparator: Placebo Group

usual treatment (respiratory function rehabilitation training + Vitamin C tablets)

  • placebo
Drug: Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral;
Other Name: VC

Drug: Placebo
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.

Other: respiratory function rehabilitation training
Health exercise, once a day




Primary Outcome Measures :
  1. The improvement proportion of pulmonary fibrosis [ Time Frame: Week 24 ]
    Evaluation of pulmonary fibrosis Improvement. pulmonary fibrosis judged by HRCT score.HRCT images are divided into four grades according to the score, and a reduction of one grade is an improvement.

  2. The improvement of lung function [ Time Frame: Week 24 ]
    FVC, FEV1, FVC/FEV1


Secondary Outcome Measures :
  1. The improvement proportion of pulmonary inflammation [ Time Frame: Week 24 ]
    Evaluation of pulmonary inflammation Improvement

  2. The improvement proportion of clinical symptom [ Time Frame: Week 24 ]
    Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19

  3. Quality of Life-BREF (QOL-BREF) [ Time Frame: Week 24 ]
    This scale can reflect the quality of life of patients to some extent.

  4. Patient Health Questionnaire-9(PHQ-9) [ Time Frame: Week 24 ]
    This scale can reflect the quality of life of patients to some extent.

  5. Generalized anxiety disorder-7(GAD-7) [ Time Frame: Week 24 ]
    This scale can reflect the quality of life of patients to some extent.

  6. The 6-minute walk distance [ Time Frame: Week 24 ]
    Evaluation of Lung Function Improvement



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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (I) Discharged patients fulfilling the diagnostic criteria of COVID-19 (China Diagnosis and Treatment Protocol for COVID-19 (Trial Version 7); (II) COVID-19 RNA in respiratory specimens or blood specimens of patients is negative (>2 times), assayed by real-time fluorescent polymerase chain reaction test (RT-PCR); (III) Pulmonary CT scans within 7 days showed that there were still unabsorbed inflammation or pulmonary fibrosis in the lungs; (IV) Age 18-70.

Exclusion criteria

  • Patients who have undergone lung surgery that affects pulmonary function, such as pulmonary transplantation, pulmonary resection, pulmonary volume reduction, etc;
  • Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;
  • Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;
  • Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;
  • Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;
  • Resting heart rate >120 times/min;
  • Systolic blood pressure > 180 mmHg, diastolic blood pressure > 100 mmHg;
  • Unstable angina pectoris or myocardial infarction occurring within the last month;
  • Severe obesity (BMI > 30 kg/m2);
  • Allergic constitution, allergic to the drug components involved in the treatment program;
  • Pregnant or breastfeeding women;
  • Patients with disabilities who are unable to complete the efficacy evaluation questionnaires;
  • Difficult collaborators with poor mental health status, suffering from mental illness, patients without self-control, unable to express clearly;
  • Those who are participating in other clinical trials;
  • According to the investigator's judgment, patients whose enrollment complications or poor compliance will affect the efficacy and safety evaluation.

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


Locations
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China, Shanghai
Shuguang Hospital
Shanghai, Shanghai, China, 201203
Sponsors and Collaborators
ShuGuang Hospital
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People's Hospital
Wuhan No.1 Hospital
Wuhan Third Hospital
Huangshi Hospital of Traditional Chinese Medicine
Investigators
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Study Director: Chenghai Liu Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
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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: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pulmonary Fibrosis
Fibrosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents