Status:
COMPLETED
Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
Lead Sponsor:
ShuGuang Hospital
Collaborating Sponsors:
Hubei Hospital of Traditional Chinese Medicine
Jingmen No.1 People's Hospital
Conditions:
Pulmonary Fibrosis Due to COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 F...
Detailed Description
The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the recovery period, but there are no certain drugs or treatment to cope with this situation. Our previous stud...
Eligibility Criteria
Inclusion
- Inclusion criteria (I) Discharged patients fulfilling the diagnostic criteria of COVID-19 (China Diagnosis and Treatment Protocol for COVID-19 (Trial Version 7); (II) COVID-19 RNA in respiratory specimens or blood specimens of patients is negative (\>2 times), assayed by real-time fluorescent polymerase chain reaction test (RT-PCR); (III) Pulmonary CT scans within 7 days showed that there were still unabsorbed inflammation or pulmonary fibrosis in the lungs; (IV) Age 18-70.
- 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.
Exclusion
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2021
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04279197
Start Date
April 23 2020
End Date
March 24 2021
Last Update
January 3 2022
Active Locations (1)
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1
Shuguang Hospital
Shanghai, Shanghai Municipality, China, 201203