COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49840

Yan Kang

kangyan_hx@163.com

2020-02-20

Not recruiting

RCT

Randomized

Parallel

Not reported

single-center

Treatment

(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.

(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.

2

West China Hospital

18

None

China

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

40

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;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 0

[{"arm_notes": "", "treatment_id": 964, "treatment_name": "Pd-1 mab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]