Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

Exclusion Criteria

• •Subject who meets any of the following criteria will be excluded from the trial:
• •1. 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.
• •2. 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.
• •3. Subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization.
• •4. Subjects with hypersensitivity history to any ingredient contained in the drug.
• •5. 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)
• •6. Pregnant or lactating woman.
• •7. Subjects who have participated in other interventional clinical trials in the last 3 months or during this trial.
• •8. Any other circumstances that the investigator considers inappropriate for the participation in this study.