Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

COVID-19 Pneumonia Clinical Trial

Official title: Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

Status Recruiting

Clinical 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.

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.

Clinical Trial 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:

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. ;

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Fibrosis
• Pulmonary Fibrosis

• NCT number: NCT05890573
• Study type: Interventional
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Haibin Dai, Professor
• Phone: +860571-87783891
• Email: haibindai@zju.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2024
• Completion date: December 31, 2024