novel coronavirus disease (COVID-19)
Conditions
Interventions
Experimental group:PD-1 mAb + Standard treatment
Control group:Standard treatment
Sponsors
West China Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) RT-PCR detection of the respiratory or blood samples shows positive nucleic acid of the novel coronavirus; (2) Gene sequence of the virus in respiratory or blood samples are highly homologous to the known coronaviruses; (3) The CT images of chest shows radiographic features of pneumonia; (4) Patients with severe or critical conditions; (5) Aged >=18, male or female; (6) The subjects should volunteer to join the study, sign the informed consent, have good compliance and cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: (1) Subjects who have any active autoimmune disease or history of autoimmune disease; (2) Subjects who received immunosuppressive therapy by using immunosuppressant, or systemic or absorbable topic hormone therapy (temprednisone or other therapeutic hormones with a dosage >10 mg/day) within 14 days prior to the administration of the studied drug; (3) Severe allergic reaction to other monoclonal antibodies; (4) Women in pregnancy or lactation; (5) Human immunodeficiency virus (HIV) infection; (6) Subjects with abnormal coagulation, bleeding tendency or undergoing thrombolysis or anticoagulation; (7) Subjects with any known hereditary or acquired bleeding and thrombotic tendencies (e.g. hemophiliacs, coagulation disorders or thrombocytopenia); (8) Subjects who have previously received other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil count;Lymphocyte count;Monocyte / macrophage count;Monocyte / macrophage function test;NK cell count;DC cell count;PD-1( immunosuppressive biomarker );PD-L1(immunosuppressive biomarker );CTLA4 (immunosuppressive biomarker );CD79;Blnk;Il7r;T lymphocyte count;CD4+ T lymphocyte count;CD8+ T lymphocyte count;B lymphocyte count;NK cell count;Proportion of navie CD4+ T lymphocytes to CD4+ T lymphocytes;Proportion of memory CD4+ T lymphocyte to CD4+ T lymphocytes;Proportion of CD4+ T lymphocyte subsets to CD4+ T lymphocytes;Proportion of CD8+ CD28+ subsets to CD8 + T lymphocytes;Activation ratio of CD8+ T lymphocytes;Ratio of CD4+ T lymphocytes to CD8+ T lymphocytes; | — |
Countries
China
Contacts
Public ContactYan Kang
West China Hospital, Sichuan University
Outcome results
None listed