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Auxora for the Treatment of AKI and Modulation of Injurious “Crosstalk” with the Lung: A Randomized Control Trial (KOURAGE)

Internal Medicine Nephrology Pulmonology Endocrinology Kidney Disease Respiratory Distress Syndrome Respiratory Failure Kidney Failure Diabetes Adult Subjects

Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.

AV001-004, AV-001 for Pneumonia

Internal Medicine Infectious Disease Pulmonology Heart and Vascular COVID-19 Influenza Respiratory Distress Syndrome Bacterial Infectious Diseases Lung Disease Infectious Disease Vascular Disease Adult Subjects

A Phase 2a, randomized, double-blind, placebo-controlled, multiple ascending dose study in patients who are hospitalized with presumed pneumonia requiring supplemental oxygen therapy. The purpose of this study is to examine the safety, tolerability and efficacy of AV-001 Injection administration daily to the earlier of day 28 or EOT (day prior to hospital discharge). A total of 120 eligible patients (20 patients in each of cohort 1, 2 and 3 and 60 patients in cohort 4) will be recruited from up to 25 participating institutions/hospitals. Patients will be randomized in a 1:1 ratio to receive either AV-001 Injection or AV-001 placebo Injection, together with standard of care (SOC).