Pulmonary Fibrosis after Severe COVID-19 Pneumonia.
Conditions
Interventions
Treatment group:Pirfenidone, nasogastric/oral, 200 mg three times a day in the first week, 400 mg three times a day in the second week, and 600 mg three times a day for four weeks in the third and fou
Control group:Standard treatment for critically ill patients with new coronary pneumonia: respiratory support including mechanical ventilation, nebulized inhalation, mechanically assisted expectoratio
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-90 years old. 2.Respiratory specimens are tested positive for novel coronavirus nucleic acid by fluorescence quantitative PCR. 3.There are clinical manifestations and abnormal chest images related to COVID-19 Pneumonia. 4.The ratio of arterial partial pressure of oxygen/absorbed oxygen concentration (PaO2/FiO2) <=200mmHg. 5.HRCT signs of pulmonary fibrosis includeing diffuse linear shadows, reticular shadows, subpleural lines, and other changes in both lungs, with even an increase in reticular shadows, distortion of bronchi, traction bronchiectasis, and honeycomb-like changes. These changes must appear in at least two lobes of the lung.
Exclusion criteria
Exclusion criteria: 1.Known interstitial lung disease. 2.Extrapulmonary physiological limitations (such as chest wall malformation, large pleural effusion, pneumothorax, pulmonary bullae, etc.). 3.Sever pulmonary hypertension (PAH). 4.Chronic heart failure. 5.Severe liver function abnormalities: chronic liver disease, AST and ALT > 1.5 x ULN, bilirubin > 1.5x ULN. 6.Severe renal function abnormalities: chronic renal failure or creatinine clearance =160/100mmHg), myocardial infarction or unstable angina, and central nervous system lesions in the 6 months before screening. 9.Women who are pregnant, breastfeeding, or planning to pregnant. 10.Patients with mental disorders, unable to follow the test or withdraw from the test. 11.Patients are expected to survival less than a week and unwilling to treat.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of non-progression of pulmonary fibrosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of endotracheal intubation;The duration of mechanical ventilation;The time without mechanical ventilation;Side effects of pirfenidone;Mortality;The length of ICU stay;The length of hospital stay;Changes of serum biomarkers for pulmonary fibrosis; | — |
Countries
China
Contacts
Public ContactJingjing Hao
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed