Severe pneumonia
Conditions
Interventions
single arm:lzm008 combined with routine treatment
Sponsors
151 Yanjiang Road West, Guangzhou, Guangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in the clinical study; patients and their families fully understand and know the study and sign the informed consent form (ICF); willing to follow and complete all test procedures; 2. Aged >= 18 years, both male and female; 3. Chest CT / MRI showed pulmonary inflammation; 4. Pneumonia severity index (PSI) III - IV, or PaO2 / FiO2 (P / F) = 5.9pg/ml or if it is monitored continuously, it is higher than that of the day before severe disease; 6. CD4/CD8 > 2; 7. There is at least one clinical toxic symptom, such as hypotension, hypoxemia (PO2 < 90%) or abnormal neurological symptoms (including mental state change, mental retardation, convulsion, etc.).
Exclusion criteria
Exclusion criteria: 1. Patients with primary and acquired immunodeficiency syndrome; 2. The presence or combination of respiratory diseases affecting the end-point evaluation of this study, such as: clear respiratory bacterial infection, asthma requiring daily treatment, acute tracheobronchial pneumonia, etc; 3. Pregnant women or breast-feeding women; 4. According to the judgment of the researcher, the previous or existing diseases may affect the end-point evaluation of this study, such as malignant tumors, autoimmune diseases, serious liver and kidney diseases, blood system diseases, etc; 5. The patients with the increase of GPT or GST more than 5 times of the normal upper limit; 6. One of the following situations occurs: Those who have respiratory failure and need mechanical ventilation;Shock; Other organ failure should be monitored and treated by ICU; 7. Patients with a history of allergy to the study drug or excipients; 8. Those who have known the following infection or infection history: recurrent active fungus, Mycobacterium or other infection, including but not limited to tuberculosis (TB) and atypical mycobacterium disease, and granulomatosis found in chest CT examination; 9. In the screening period, those who are positive for hepatitis C virus (HCV) antibody and Treponema pallidum (TP) antibody; 10. In the screening period, HBsAg was positive, or HBcAb was positive, and the hepatitis B virus load was higher than the local normal value; 11. Patients who participated in other clinical studies at the same time, or planned to start the study treatment less than 14 days before the end of the drug treatment in the previous clinical study; 12. The patient has any situation that can not guarantee the safety of the study; 13. Patients who may be transferred to other non participating hospitals in the near future; 14. Patients considered inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRP;IL-2;IL-6;IL-10;GCSF;CXCL10;MCP1;MIP1A;TNF-a;IL1ß;IL4;IL-17;IL-12P70;IFN-?;RAGE;HGF;VEGFR2; | — |
Countries
China
Contacts
Public ContactHe Jianxing
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed