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.
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 studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis
induced by bleomycin in animals, and improve the pulmonary function in the patients with
chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical
study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or
pulmonary function injury in the recovery period of COVID-19 and expect to improve the
prognosis.
This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls
142 patients who had been diagnosed with COVID-19, but currently they are negative for viral
testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly
assigned into Placebo group and FZHY group. All patients are given usual treatment such as
respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng
Huayu tablets, and the control group is given placebo. Each patient will be observed for 24
weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement
proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung
function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement
proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality
of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety
disorder-7 (GAD-7) score. The safety also be observed.
Drug: Fuzheng Huayu Tablet
FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Other Name: FZHY
Drug: Vitamin C tablets
Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
Other Name: VC
Drug: Placebo
Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.
Other: respiratory function rehabilitation training
Health exercise, once a day
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.
Shuguang Hospital
Shanghai, Shanghai, China
Chenghai Liu, Study Director
Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine