Efficacy of Bailing Capsule on Pulmonary Fibrosis After COVID-19

Inclusion Criteria:

1. Age 18-80 years old, gender unlimited;
2. Fibrous changes in the lungs after COVID-19 pneumonia:
3. If COVID-19 is positive within the past 2 months, qualitative analysis ofSARS-CoV-2 RNA is conducted by antigen detection or PCR detection;
4. During the screening period, chest HRCT showed the characteristics of pulmonaryinterstitial lesions (including ground glass shadow, grid shadow, tractablebronchiectasis, septal thickening and early honeycomb shadow, etc.), withfibrosis affected area > 5%;
5. COVID-19 negative was confirmed during the screening period, and SARS-CoV-2 RNAwas qualitatively verified by antigen detection or PCR detection;
6. Severity grade 2 (moderate) or 3 (severe) according to the mMRC Dyspnea Scale at thescreening visit;
7. Able to perform pulmonary function tests (PFT) and decreased lung function FVC and/orDLCO <70% of the predicted value at the screening visit;
8. Able to complete the 6-minute walking test and questionnaire survey;
9. Fertile female patients must have negative pregnancy test results during screening;
10. Volunteer to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. Prior medical history of lung disease (including IPF, bronchial asthma, COPD, lungcancer or pulmonary hypertension) prior to positive diagnosis of COVID-19 pneumonia;
2. Nephrotic syndrome, moderate to severe chronic renal failure, or eGFR < 60ml/min atenrollment;
3. Major cardiovascular disease, including chronic heart failure grade III or IV,clinically significant sinus arrhythmias, ventricular tachycardia, ventricularfibrillation, unstable angina, and severe hypertension (≥160/110 mmHg) that was notunder control or was being actively treated within the first 6 months of enrollment;
4. Screening of patients with abnormal liver function, the criteria are as follows: totalbilirubin > 1.5×ULN; ALT > 3 x ULN; AST > 3 x ULN;
5. Severe pulmonary arterial hypertension (PAH) meets any of the following conditions:
6. severe right heart failure in the past;
7. Cardiac index indicated by right cardiac catheter insertion history ≤2 L/min/m²;
8. PAH requiring epizoprostol/treprostol parenteral treatment;
9. Patients with bleeding risk:
10. Known genetic susceptibility to bleeding;
11. fibrinolysis, full-dose anticoagulant therapy, or high-dose antiplatelet therapyare required;
12. Patients had received chest and neck radiotherapy or chemotherapy before screening;
13. Inability to swallow the study drug;
14. History of active malabsorption disorders or gastrointestinal resection;
15. Systemic corticosteroids (e.g. Prednisone, dexamethasone) were administered within 5days of the first day of administration of the study intervention;
16. After discharge, take preparations containing cordyceps or anti-pulmonary fibrosisdrugs (such as pirfenidone, Nidanib, imatinib, penicillamine, colchicine, tumornecrosis factor α receptor blockers, etc.);
17. Participation in other clinical trials, use of other investigational drugs orinvestigational devices within 30 days prior to randomization;
18. Women or men of childbearing age refuse to use contraception during the study period;
19. Pregnant or lactating women;
20. Any other factors that the investigator has determined may be inappropriate forparticipation in the clinical study;
21. Patients suffered major trauma or underwent major surgery within 28 days prior totreatment with the study drug;
22. Other Chinese medicines containing cordyceps were used for treatment within 15 daysbefore and during the study period.