Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

Exclusion Criteria

• •Refractory septic shock.
• •Not expected to survive 72 hours.
• •Hospital-acquired or ventilator-associated pneumonia or known or suspected pneumonia due to aspiration or other physical injury or trauma or tuberculosis.
• •Known or suspected hypersensitivity to AON-D21 or any components of the formulation used (e.g., PEG, mannitol or EDTA) or a history of clinically relevant allergy requiring continuous treatment, or of anaphylaxis.
• •Known fibrotic lung disease, bronchiectasis or any other known severe chronic respiratory disease.
• •Active malignant disease.
• •Factors other than a pathogen suspected or confirmed to be causative for the respiratory insufficiency.
• •Hepatocellular injury defined by an ALT or AST value ≥ 3 times the ULN. Known acute or chronic liver disease with Child-Pugh C (See Appendix 13.6.2).
• •Any medical disease or condition that, in the opinion of the investigator(s), compromises the participant's safety or compromises the interpretation of the results.
• •Receiving chronic immunosuppressive therapy in relevant doses.
• •Known immunodeficiency disease/condition.
• •Nursing and pregnant women (defined as the state after conception until the termination of gestation, screened in all women of child-bearing potential with a chorionic gonadotrophin (hCG) blood test (local laboratory).
• •Current or recent participation in an investigational trial.
• •Systemic treatment with any complement inhibitor.
• •Known complement deficiency.
• •Unlikely to remain at the investigational site beyond 96 h.