Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

NCT05890573 | Unknown

• 1 other identifier: 2023-0091
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis; COVID-19 Pneumonia

Keywords

PCPF; COVID-19; Bailing Capsule

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Secondary Outcomes (11)

• Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)

  Week 4，Week 8，Week 12

• FVC

  Week 4，Week 8，Week 12

• DLCO

  Week 4，Week 8，Week 12

• FEV1

  Week 4，Week 8，Week 12

• FEV1/FVC

  Week 4，Week 8，Week 12

Study Arms (2)

Bailing capsule group

EXPERIMENTAL

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

Drug: Bailing capsule

Blank group

NO INTERVENTION

Blank group:no anti-fibrosis treatment is given.

Interventions

Bailing capsule DRUG

6 Bailing capsules,po,tid,12 weeks

Bailing capsule group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Dai Haibin

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Fibrosis; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Haibin Dai, Professor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haibin Dai, Professor

CONTACT

+860571-87783891; haibindai@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 6, 2023
• Study Start: April 16, 2024
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2023-05

Locations

CN (1)