Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can affect patients'lung function and even life health.This study aims to observe the efficacy and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ShuGuang Hospital
• Collaborators: Hubei Hospital of Traditional Chinese Medicine; Jingmen No.1 People's Hospital; Jingmen No.1 People’s Hospital; Tongji Hospital; Wenzhou Central Hospital; Wuhan No.1 Hospital; Wuhan Third Hospital; Wuhan Union Hospital, China
• Treatments: Acetylcysteine; Ascorbic Acid; N-monoacetylcystine

Criteria

Inclusion criteria

• Compliance with the diagnostic criteria for COVID-19 (China Diagnosis and Treatment Protocol for COVID-19(Trial Version 7);

• Real-time fluorescent polymerase chain reaction test to detect of SARS-CoV-2 nucleic acid in respiratory specimens or blood specimens of patients with negative results (>2 times);

• Pulmonary CT scans within 7 days showed that there were still unabsorbed inflammation or pulmonary fibrosis in the lungs;

• Age 18-70;

• Six-minute walk distance less than 350 meters;

• Participate in clinical research voluntarily and sign informed consent. Exclusion criteria

• Patients who have undergone lung surgery that affects pulmonary function, such as pulmonary transplantation, pulmonary resection, pulmonary volume reduction, etc;

• Relying on mechanical ventilation to maintain pulmonary function, such as ventilators;

• Combined with chronic pulmonary diseases affecting pulmonary function, such as chronic obstructive pulmonary disease, other known causes of interstitial pulmonary disease;

• Patients with diseases affecting cardiac function, such as pulmonary circulation hypertension, heart failure, peripheral vascular disease, fibromyalgia, and pacemaker installation;

• Patients with severe underlying diseases affecting survival, including uncontroled cardiac, renal, digestive, hematological, neuropsychiatric, immune, metabolic diseases, malignant diseases and severe malnutrition;

• Resting heart rate >120 times/min;

• Systolic blood pressure > 180 mmHg, diastolic blood pressure > 100 mmHg;

• Unstable angina pectoris or myocardial infarction occurring within the last month;

• Severe obesity (BMI > 30 kg/m2);

• Allergic constitution, allergic to the drug components involved in the treatment program;

• Pregnant or breastfeeding women;

• Patients with disabilities who are unable to complete the efficacy evaluation questionnaires;

• Difficult collaborators with poor mental health status, suffering from mental illness, patients without self-control, unable to express clearly;

• Those who are participating in other clinical trials;

• According to the investigator's judgment, patients whose enrollment complications or poor compliance will affect the efficacy and safety evaluation.