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Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

Primary Purpose

Pulmonary Fibrosis, COVID-19 Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bailing capsule
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring PCPF, COVID-19, Bailing Capsule

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-80 years old, gender unlimited; Fibrous changes in the lungs after COVID-19 pneumonia: If COVID-19 is positive within the past 2 months, qualitative analysis of SARS-CoV-2 RNA is conducted by antigen detection or PCR detection; During the screening period, chest HRCT showed the characteristics of pulmonary interstitial lesions (including ground glass shadow, grid shadow, tractable bronchiectasis, septal thickening and early honeycomb shadow, etc.), with fibrosis affected area > 5%; COVID-19 negative was confirmed during the screening period, and SARS-CoV-2 RNA was qualitatively verified by antigen detection or PCR detection; Severity grade 2 (moderate) or 3 (severe) according to the mMRC Dyspnea Scale at the screening visit; Able to perform pulmonary function tests (PFT) and decreased lung function FVC and/or DLCO <70% of the predicted value at the screening visit; Able to complete the 6-minute walking test and questionnaire survey; Fertile female patients must have negative pregnancy test results during screening; Volunteer to participate in this clinical trial and sign an informed consent form. Exclusion Criteria: Prior medical history of lung disease (including IPF, bronchial asthma, COPD, lung cancer or pulmonary hypertension) prior to positive diagnosis of COVID-19 pneumonia; Nephrotic syndrome, moderate to severe chronic renal failure, or eGFR < 60ml/min at enrollment; Major cardiovascular disease, including chronic heart failure grade III or IV, clinically significant sinus arrhythmias, ventricular tachycardia, ventricular fibrillation, unstable angina, and severe hypertension (≥160/110 mmHg) that was not under control or was being actively treated within the first 6 months of enrollment; Screening of patients with abnormal liver function, the criteria are as follows: total bilirubin > 1.5×ULN; ALT > 3 x ULN; AST > 3 x ULN; Severe pulmonary arterial hypertension (PAH) meets any of the following conditions: severe right heart failure in the past; Cardiac index indicated by right cardiac catheter insertion history ≤2 L/min/m²; PAH requiring epizoprostol/treprostol parenteral treatment; Patients with bleeding risk: Known genetic susceptibility to bleeding; fibrinolysis, full-dose anticoagulant therapy, or high-dose antiplatelet therapy are required; Patients had received chest and neck radiotherapy or chemotherapy before screening; Inability to swallow the study drug; History of active malabsorption disorders or gastrointestinal resection; Systemic corticosteroids (e.g. Prednisone, dexamethasone) were administered within 5 days of the first day of administration of the study intervention; After discharge, take preparations containing cordyceps or anti-pulmonary fibrosis drugs (such as pirfenidone, Nidanib, imatinib, penicillamine, colchicine, tumor necrosis factor α receptor blockers, etc.); Participation in other clinical trials, use of other investigational drugs or investigational devices within 30 days prior to randomization; Women or men of childbearing age refuse to use contraception during the study period; Pregnant or lactating women; Any other factors that the investigator has determined may be inappropriate for participation in the clinical study; Patients suffered major trauma or underwent major surgery within 28 days prior to treatment with the study drug; Other Chinese medicines containing cordyceps were used for treatment within 15 days before and during the study period.

Sites / Locations

  • Dai Haibin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bailing capsule group

Blank group

Arm Description

Bailing capsule group:6 Bailing capsules,po, tid,12 weeks.

Blank group:no anti-fibrosis treatment is given.

Outcomes

Primary Outcome Measures

Rate of clinically significant change in FVC and/or DLCO at Week 12 relative to the baseline value
Clinically significant changes include a relative ≥ 10% increase in FVC or a relative increase in FVC within the range from ≥ 5% to <10% and a relative ≥ 15% in DLCO

Secondary Outcome Measures

Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)
6MWD changing value
FVC
FVC(L)changing value
DLCO
DLCO( mmHg)changing value
FEV1
FEV1( L)changing value
FEV1/FVC
FEV1/FVC( %)changing value
TLC
TLC( L)changing value
The rate of reduction in the lung damage degree based on the high-resolution computed tomography(HRCT) at Week 12 relative to the baseline value
Classification of lung damage includes the following stages: CT-0 (norm), CT-1 (< 25% of lung damage), CT-2 (25-50% of lung damage), CT-3 (50-75% of lung damage), CT-4 (> 75% of lung damage)
Change in mMRC Dyspnea Score from the baseline value
m-MRC changing value
Change in the overall score of the SF-36 Questionnaire relative to the baseline value
36-item Short-Form(SF-36) is a universal scale of life quality developed by Medical Outcomes Study(MOS), which is widely recognized and used in the world. This scale has 8 dimensions to evaluate health-related quality of life (HRQOL), which can be divided into two categories of physiological health and mental health, namely physiological function (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). 50 is a normal average score, 0 is the lowest, 100 is the highest.The higher the score, the better the health.
Change in the overall score of the CQ-11D Questionnaire relative to the baseline value
TCM Life Quality Evaluation Scale (CQ-11D) is an industry standard document approved and officially released by the China Association of Traditional Chinese Medicine. It is mainly used to evaluate the healthy life quality of the population receiving TCM intervention and the general population, with a total of 11 items. The higher the score, the worse the healthy quality of life status.
The rate of adverse events (AEs)
AE

Full Information

First Posted
May 29, 2023
Last Updated
August 6, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05890573
Brief Title
Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19
Official Title
Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

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
Pulmonary fibrosis is a sequela of severe infection COVID-19.The prevalence of PCFP ranged from 2% to 45%,and the pathogenesis of PCFP has not been clearly elucidated.The ingredient of Bailing capsule is Cs-C-Q80,it has obvious protective effect on lung. Studies have shown that Bailing capsule may improve the clinical symptoms of PCPF patients through anti-fibrosis, oxidation and anti-inflammatory effects in multiple pathways. The purpose of this study was to evaluate the efficacy and safety of bailing capsule in treating PCFP after COVID-19 infection.
Detailed Description
This is a multicenter, prospective, open, randomized controlled clinical study. Bailing capsule was used for 12 weeks of convalescent treatment in patients with COVID-19 infection to evaluate the efficacy and safety of Bailing capsule on pulmonary fibrosis changes after COVID-19 infection. The study consisted of a 1-week screening period and a 12-week randomized treatment period. Screening period (V0) : All subjects who have signed informed consent will enter a screening period (up to 7 days) to assess eligibility. Subjects with confirmed pulmonary fibrosis changes after COVID-19 infection were required to complete relevant procedures, examinations and assessments according to the study procedure table during the screening period. Randomized treatment period (V1~V3) : The randomized treatment period included V1 to V3 visits. At baseline visit (V1), eligible subjects will be randomly assigned to 6 capsules of Bailing Capsule, tid group, or blank control group in a 1:1 ratio, and receive appropriate treatment during the treatment period: Experimental group: 6 capsules of Bailing capsule, tid group (n=121), a total of 12 weeks. Control group: blank control (n=121). During randomized treatment, subjects will be required to complete procedures, examinations, and evaluations according to the study protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, COVID-19 Pneumonia
Keywords
PCPF, COVID-19, Bailing Capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bailing capsule group
Arm Type
Experimental
Arm Description
Bailing capsule group:6 Bailing capsules,po, tid,12 weeks.
Arm Title
Blank group
Arm Type
No Intervention
Arm Description
Blank group:no anti-fibrosis treatment is given.
Intervention Type
Drug
Intervention Name(s)
Bailing capsule
Intervention Description
6 Bailing capsules,po,tid,12 weeks
Primary Outcome Measure Information:
Title
Rate of clinically significant change in FVC and/or DLCO at Week 12 relative to the baseline value
Description
Clinically significant changes include a relative ≥ 10% increase in FVC or a relative increase in FVC within the range from ≥ 5% to <10% and a relative ≥ 15% in DLCO
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)
Description
6MWD changing value
Time Frame
Week 4,Week 8,Week 12
Title
FVC
Description
FVC(L)changing value
Time Frame
Week 4,Week 8,Week 12
Title
DLCO
Description
DLCO( mmHg)changing value
Time Frame
Week 4,Week 8,Week 12
Title
FEV1
Description
FEV1( L)changing value
Time Frame
Week 4,Week 8,Week 12
Title
FEV1/FVC
Description
FEV1/FVC( %)changing value
Time Frame
Week 4,Week 8,Week 12
Title
TLC
Description
TLC( L)changing value
Time Frame
Week 4,Week 8,Week 12
Title
The rate of reduction in the lung damage degree based on the high-resolution computed tomography(HRCT) at Week 12 relative to the baseline value
Description
Classification of lung damage includes the following stages: CT-0 (norm), CT-1 (< 25% of lung damage), CT-2 (25-50% of lung damage), CT-3 (50-75% of lung damage), CT-4 (> 75% of lung damage)
Time Frame
Week 12
Title
Change in mMRC Dyspnea Score from the baseline value
Description
m-MRC changing value
Time Frame
Week 12
Title
Change in the overall score of the SF-36 Questionnaire relative to the baseline value
Description
36-item Short-Form(SF-36) is a universal scale of life quality developed by Medical Outcomes Study(MOS), which is widely recognized and used in the world. This scale has 8 dimensions to evaluate health-related quality of life (HRQOL), which can be divided into two categories of physiological health and mental health, namely physiological function (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE) and mental health (MH). 50 is a normal average score, 0 is the lowest, 100 is the highest.The higher the score, the better the health.
Time Frame
Week 12
Title
Change in the overall score of the CQ-11D Questionnaire relative to the baseline value
Description
TCM Life Quality Evaluation Scale (CQ-11D) is an industry standard document approved and officially released by the China Association of Traditional Chinese Medicine. It is mainly used to evaluate the healthy life quality of the population receiving TCM intervention and the general population, with a total of 11 items. The higher the score, the worse the healthy quality of life status.
Time Frame
Week 12
Title
The rate of adverse events (AEs)
Description
AE
Time Frame
Week 4,Week 8,Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years old, gender unlimited; Fibrous changes in the lungs after COVID-19 pneumonia: If COVID-19 is positive within the past 2 months, qualitative analysis of SARS-CoV-2 RNA is conducted by antigen detection or PCR detection; During the screening period, chest HRCT showed the characteristics of pulmonary interstitial lesions (including ground glass shadow, grid shadow, tractable bronchiectasis, septal thickening and early honeycomb shadow, etc.), with fibrosis affected area > 5%; COVID-19 negative was confirmed during the screening period, and SARS-CoV-2 RNA was qualitatively verified by antigen detection or PCR detection; Severity grade 2 (moderate) or 3 (severe) according to the mMRC Dyspnea Scale at the screening visit; Able to perform pulmonary function tests (PFT) and decreased lung function FVC and/or DLCO <70% of the predicted value at the screening visit; Able to complete the 6-minute walking test and questionnaire survey; Fertile female patients must have negative pregnancy test results during screening; Volunteer to participate in this clinical trial and sign an informed consent form. Exclusion Criteria: Prior medical history of lung disease (including IPF, bronchial asthma, COPD, lung cancer or pulmonary hypertension) prior to positive diagnosis of COVID-19 pneumonia; Nephrotic syndrome, moderate to severe chronic renal failure, or eGFR < 60ml/min at enrollment; Major cardiovascular disease, including chronic heart failure grade III or IV, clinically significant sinus arrhythmias, ventricular tachycardia, ventricular fibrillation, unstable angina, and severe hypertension (≥160/110 mmHg) that was not under control or was being actively treated within the first 6 months of enrollment; Screening of patients with abnormal liver function, the criteria are as follows: total bilirubin > 1.5×ULN; ALT > 3 x ULN; AST > 3 x ULN; Severe pulmonary arterial hypertension (PAH) meets any of the following conditions: severe right heart failure in the past; Cardiac index indicated by right cardiac catheter insertion history ≤2 L/min/m²; PAH requiring epizoprostol/treprostol parenteral treatment; Patients with bleeding risk: Known genetic susceptibility to bleeding; fibrinolysis, full-dose anticoagulant therapy, or high-dose antiplatelet therapy are required; Patients had received chest and neck radiotherapy or chemotherapy before screening; Inability to swallow the study drug; History of active malabsorption disorders or gastrointestinal resection; Systemic corticosteroids (e.g. Prednisone, dexamethasone) were administered within 5 days of the first day of administration of the study intervention; After discharge, take preparations containing cordyceps or anti-pulmonary fibrosis drugs (such as pirfenidone, Nidanib, imatinib, penicillamine, colchicine, tumor necrosis factor α receptor blockers, etc.); Participation in other clinical trials, use of other investigational drugs or investigational devices within 30 days prior to randomization; Women or men of childbearing age refuse to use contraception during the study period; Pregnant or lactating women; Any other factors that the investigator has determined may be inappropriate for participation in the clinical study; Patients suffered major trauma or underwent major surgery within 28 days prior to treatment with the study drug; Other Chinese medicines containing cordyceps were used for treatment within 15 days before and during the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haibin Dai, Professor
Phone
+860571-87783891
Email
haibindai@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibin Dai, Professor
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dai Haibin
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

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