Pulmonary FibrosisNCT05890573
Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19
A study testing Bailing capsule in people with Pulmonary Fibrosis and COVID-19 Pneumonia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis, COVID-19 Pneumonia
- What is being tested?
- Bailing capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dai Haibin
Hangzhou, Zhejiang, 310009
haibin dai
About this study
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.
Read the 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.
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia
- Being tested
- Bailing capsule
- Keywords
- PCPF, COVID-19, Bailing Capsule
- Medical subject headings
- Pulmonary Fibrosis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bailing capsuleDrug
6 Bailing capsules,po,tid,12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bailing capsule group | Experimental | Bailing capsule group:6 Bailing capsules,po, tid,12 weeks. Receives: Drug: Bailing capsule |
| Blank group | No intervention | Blank group:no anti-fibrosis treatment is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (11)
Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)
6MWD changing value
Measured: Week 4，Week 8，Week 12
FVC
FVC（L）changing value
Measured: Week 4，Week 8，Week 12
DLCO
DLCO（ mmHg）changing value
Measured: Week 4，Week 8，Week 12
FEV1
FEV1（ L）changing value
Measured: Week 4，Week 8，Week 12
FEV1/FVC
FEV1/FVC（ %）changing value
Measured: Week 4，Week 8，Week 12
TLC
TLC（ L）changing value
Measured: Week 4，Week 8，Week 12
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)
Measured: Week 12
Change in mMRC Dyspnea Score from the baseline value
m-MRC changing value
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
The rate of adverse events (AEs)
AE
Measured: Week 4，Week 8，Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start16 Apr 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haibin Dai, Professor, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890573
- Sponsor's protocol ID
- 2023-0091
- Status last verified
- May 2023
- First submitted
- 29 May 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19
- ClinicalTrials.gov ID
- NCT05890573
- Acronym / sponsor ID
- 2023-0091
- Conditions
- Pulmonary Fibrosis, COVID-19 Pneumonia
- Keywords
- PCPF, COVID-19, Bailing Capsule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Apr 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bailing capsule group | Experimental | Drug: Bailing capsuleBailing capsule group:6 Bailing capsules,po, tid,12 weeks. |
| Blank group | No intervention | –Blank group:no anti-fibrosis treatment is given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-80 years old, gender unlimited;
- Fibrous changes in the lungs after COVID-19 pneumonia:
- 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;
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bailing capsule6 Bailing capsules,po,tid,12 weeks | Drug | Bailing capsule group |
Primary outcome
Rate of clinically significant change in FVC and/or DLCO at Week 12 relative to the baseline value
Time frame: Week 12
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
11 secondary outcomes
Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)
Time frame: Week 4，Week 8，Week 12
FVC
Time frame: Week 4，Week 8，Week 12
DLCO
Time frame: Week 4，Week 8，Week 12
FEV1
Time frame: Week 4，Week 8，Week 12
FEV1/FVC
Time frame: Week 4，Week 8，Week 12
TLC
Time frame: Week 4，Week 8，Week 12
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
Time frame: Week 12
Change in mMRC Dyspnea Score from the baseline value
Time frame: Week 12
Change in the overall score of the SF-36 Questionnaire relative to the baseline value
Time frame: Week 12
Change in the overall score of the CQ-11D Questionnaire relative to the baseline value
Time frame: Week 12
The rate of adverse events (AEs)
Time frame: Week 4，Week 8，Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haibin Dai, Professor principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bailing capsule in people with Pulmonary Fibrosis and COVID-19 Pneumonia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haibin Dai, Professor (+860571-87783891, haibindai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically significant change in FVC and/or DLCO at Week 12 relative to the baseline value (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.