Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Pirfenidone group:Conventional standard treatment + Pirfenidone 400mg three times a day
Sponsors
Tongji Hospital of Tongji Medical College; Huazhong Science and Technology University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. First diagnosis of novel coronavirus infection 2. Epidemiological history Travel history or residence history of Wuhan City within two weeks before the onset of illness; or patients who have had fever from Wuhan with respiratory symptoms within 14 days before the onset of illness, or have cluster Onset; 3. Clinical manifestations: (1) fever; (2) with the following imaging characteristics of pneumonia; early lesions are limited, showing patchy, subsegmental or segmental ground glass shadows, with or without thickening of lobular septum; progression Increased lesions and expanded scope, involving multiple lung lobes, some lesions consolidation, coexistence of ground glass shadows and consolidation shadows or strip shadows; diffuse lung lesions in severe stages, a few of which show "white lung", mainly consolidation , Combined with ground glass shadow, multiple cord shadow, air bronchus sign. Pleural effusion or lymphadenopathy are rare; (3) The total number of white blood cells is normal or decreased, or the lymphocyte count is decreased in the early stage of onset. On the basis of confirmed cases meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory tract secretions, and other specimens were tested by real-time fluorescent RT-PCR to detect positive nucleic acid of the new coronavirus; or viral gene sequencing was highly similar to known new coronavirus source. Trial diagnosis and treatment plan according to the fourth edition of the new Coronavirus Infected Pneumonia issued by the National Health and Health Commission; Diagnosis criteria for severe pneumonia: One of the following: (1) respiratory distress (>=30 beats / min); (2) In a resting state, SPO2<=93% under inhaled air; (3) PaO2 / FiO2<=300mmHg; Criteria for critical pneumonia: One of the following: (1) Respiratory failure, requiring mechanical ventilation; (2) shock; (3) complicated with other organ failure requires intensive care unit.
Exclusion criteria
Exclusion criteria: 1. AST and ALT> 1.5 x ULN at visit 1; 2. bilirubin> 1.5 x ULN at visit 1; 3. At visit 1, calculated by Cockcroft–Gault formula, creatinine clearance =160 / 100 mmHg) (2) Myocardial infarction within 6 months of visit 1, Unstable angina pectoris within 6 months of Visit 1; 12. History of severe central nervous system (CNS) events; 13. Known allergy to test drug; 14. Other diseases that may interfere with the testing process or that the investigator judges may interfere with the trial participation or may put patients at risk when participating in the trial; 15. Women who were pregnant, lactating or planning to become pregnant in this trial; 16. Patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| K-bld questionnaire survey;Refers to the pulse oxygen;chest CT;blood gas; | — |
Secondary
| Measure | Time frame |
|---|---|
| Within 4 weeks of death from respiratory causes;Within 4 weeks of disease progression or death;Routine lymphocyte recovery;Changes in inflammatory markers of blood (il-8 et al.);Absolute change in viral nucleic acid from baseline;Absolute change in pulmonary fibrosis survival symptom dyspnea component score from baseline;Absolute change in scores for the cough portion of survival symptoms of pulmonary fibrosis from baseline; | — |
Countries
China
Contacts
Public ContactHuilan Zhang
Tongji Hospital of Tongji Medical College; Huazhong Science and Technology University
Outcome results
None listed