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.
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: 1. Experimental group: 6 capsules of Bailing capsule, tid group (n=121), a total of 12 weeks. 2. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
6 Bailing capsules,po,tid,12 weeks
Dai Haibin
Hangzhou, Zhejiang, China
RECRUITINGRate 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
Time frame: Week 12
Change in distance covered for 6 minutes (6MWD) from the baseline value (based on 6-minute walk test)
6MWD changing value
Time frame: Week 4,Week 8,Week 12
FVC
FVC(L)changing value
Time frame: Week 4,Week 8,Week 12
DLCO
DLCO( mmHg)changing value
Time frame: Week 4,Week 8,Week 12
FEV1
FEV1( L)changing value
Time frame: Week 4,Week 8,Week 12
FEV1/FVC
FEV1/FVC( %)changing value
Time frame: Week 4,Week 8,Week 12
TLC
TLC( L)changing value
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
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
Change in mMRC Dyspnea Score from the baseline value
m-MRC changing value
Time frame: 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.
Time frame: 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.
Time frame: Week 12
The rate of adverse events (AEs)
AE
Time frame: Week 4,Week 8,Week 12
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