search
Back to results

Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu

Primary Purpose

Pulmonary Fibrosis Due to COVID-19

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fuzheng Huayu Tablet
Vitamin C tablets
Placebo
respiratory function rehabilitation training
Sponsored by
ShuGuang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis Due to COVID-19

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shuguang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FZHY Group

Placebo Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The improvement proportion of pulmonary fibrosis
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.
The improvement of lung function
FVC, FEV1, FVC/FEV1

Secondary Outcome Measures

The improvement proportion of pulmonary inflammation
Evaluation of pulmonary inflammation Improvement
The improvement proportion of clinical symptom
Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19
Quality of Life-BREF (QOL-BREF)
This scale can reflect the quality of life of patients to some extent.
Patient Health Questionnaire-9(PHQ-9)
This scale can reflect the quality of life of patients to some extent.
Generalized anxiety disorder-7(GAD-7)
This scale can reflect the quality of life of patients to some extent.
The 6-minute walk distance
Evaluation of Lung Function Improvement

Full Information

First Posted
February 15, 2020
Last Updated
December 12, 2021
Sponsor
ShuGuang Hospital
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
search

1. Study Identification

Unique Protocol Identification Number
NCT04279197
Brief Title
Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 23, 2020 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ShuGuang Hospital
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis Due to COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FZHY Group
Arm Type
Experimental
Arm Description
usual treatment (respiratory function rehabilitation training + Vitamin C tablets) Fuzheng Huayu tablets
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
usual treatment (respiratory function rehabilitation training + Vitamin C tablets) placebo
Intervention Type
Drug
Intervention Name(s)
Fuzheng Huayu Tablet
Other Intervention Name(s)
FZHY
Intervention Description
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Intervention Type
Drug
Intervention Name(s)
Vitamin C tablets
Other Intervention Name(s)
VC
Intervention Description
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Intervention Type
Other
Intervention Name(s)
respiratory function rehabilitation training
Intervention Description
Health exercise, once a day
Primary Outcome Measure Information:
Title
The improvement proportion of pulmonary fibrosis
Description
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.
Time Frame
Week 24
Title
The improvement of lung function
Description
FVC, FEV1, FVC/FEV1
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
The improvement proportion of pulmonary inflammation
Description
Evaluation of pulmonary inflammation Improvement
Time Frame
Week 24
Title
The improvement proportion of clinical symptom
Description
Discomfort symptoms include dyspnea, cough, exhausted, fatigue, insomnia, sweating, poor appetite, diarrhea, etc., which are common manifestations of patients with COVID-19
Time Frame
Week 24
Title
Quality of Life-BREF (QOL-BREF)
Description
This scale can reflect the quality of life of patients to some extent.
Time Frame
Week 24
Title
Patient Health Questionnaire-9(PHQ-9)
Description
This scale can reflect the quality of life of patients to some extent.
Time Frame
Week 24
Title
Generalized anxiety disorder-7(GAD-7)
Description
This scale can reflect the quality of life of patients to some extent.
Time Frame
Week 24
Title
The 6-minute walk distance
Description
Evaluation of Lung Function Improvement
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenghai Liu
Organizational Affiliation
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shuguang Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu

We'll reach out to this number within 24 hrs