Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

18 years old ≤ age ≤ 80 years old, both men or women.

Confirmed SARS-CoV-2 infection, and meet at least one of the following criteria:

Confirmed severe COVID-19 in no more than 5 days who meets any of the following criteria:

Respiratory distress, RR ≥ 30 times/min
Finger oxygen saturation (SpO2) ≤93% in resting state(room air)
Arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg (1 mmHg = 0.133kpa) in supine position
Pulmonary imaging shows lesion progression > 50% within 24-48 hours.

Symptoms,signs or chest imaging indicates ALI/ARDS;

Requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(HFNC).
The informed consent form signed.

Exclusion Criteria:

Subject who meets any of the following criteria will be excluded from the trial:

Subjects already progressed into critically severe COVID-19 Critical severe standards refer to FDA guidelines,as shown in Appendix 4 or sepsis and sepsis shock.
Concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (NYHA Classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. Child-Pugh score ≥ grade C); severe kidney diseases, such as renal insufficiency (GFR ≤ 15 mL/min/1.73m^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies.
Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
Subjects with hypersensitivity history to any ingredient contained in the drug.

A subject has used the following drugs within 2 weeks prior to screening procedures:

Calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.)
Proliferation inhibitors (e.g., everolimus, sirolimus, etc.)
Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.)
Recombinant human granulocyte macrophage colony stimulating factor (rhGM-CSF)/recombinant human granulocyte colony stimulating factor (rhG-CSF)
Pregnant or lactating woman.
Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
Any other circumstances that the investigator considers inappropriate for the participation in this study.