New drug AV-001 aims to help hospitalized pneumonia patients breathe easier

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able and willing to give signed informed consent * Patients hospitalized with a presumed diagnosis of pneumonia of \< 48 hours duration requiring supplemental oxygen therapy. Eligible patients include those hospitalized for a separate non-infectious reason who subsequently develop a presumed pneumonia; * Radiologic imaging (chest x-ray, CT scan, etc.) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation. Signs and symptoms: At least 1 of the following signs: * respiratory rate \> 30 breaths/min; * fever (\> 38.0ºC or \> 100.4o F); * leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3); * adults ≥ 70 years of age; altered mental status with no other recognized cause; AND at least 1 of the following symptoms: * New onset of purulent sputum or change in character of sputum or increased respiratory secretions; * New onset or worsening cough, or dyspnea, or tachypnea; * Rales or bronchial breath sounds; * Female patients of reproductive potential must be on an effective contraceptive method Exclusion Criteria: * Pregnant and/or lactating women * Patients included in any other interventional trial * Use of endotracheal intubation and mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at screening * Any concurrent serious medical condition or concomitant medication that would preclude participation in the study including but not limited to: * Septic shock as defined by systolic blood pressure (SBP) \< 90 mmHg or diastolic blood pressure (DBP) of \< 60 mmHg; * Multiple organ failure; * Are moribund irrespective of the provision of treatments; * Any significant bleeding disorder or vasculitis; * Any serious, nonhealing wound, peptic ulcer or bone fracture; * Liver cirrhosis; * History of a hypertensive crisis or hypertensive encephalopathy, or current, poorly controlled hypertension or hypotension; * Severe renal insufficiency or end stage renal disease as determined by estimated glomerular filtration rate \<30mL/min/1.73m2; * ARDS risk factors of aspiration pneumonia, non-cardiac shock, trauma, blood transfusion or drug overdose. * Any thromboembolic event within the past 3 months; * Symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia \> class II as per New York Heart Association (NYHA) classification; * History of autonomic disorders or uncontrolled hypotension * Hypersensitivity to drug products containing polyethylene glycol (PEG) * Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study