The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)

Open to people ages 18-75

• Signed and dated informed consent form (ICF) by the subject or legally authorized representative;
• Age 18-75 (inclusive);
• Assay positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus, preferably by polymerase chain reaction (PCR);
• Endotracheal intubation and mechanical ventilation (MV), within 7 days of initial intubation;
• In-dwelling arterial line;
• P/F ratio < 300;
• Mean blood pressure ≥ 65 mmHg, immediately before enrollment;
• Bilateral infiltrates seen on frontal chest radiograph.

• Life expectancy < 48 hours or do not resuscitate orders;
• Severe lung disease (home O2, forced expiratory volume at one second [FEV1] < 2 liters) not likely to respond to therapy or profound hypoxemia (ie, OI ≥ 25 or P/F < 100);
• Severe renal impairment (creatinine clearance < 30 mL/min);
• Within the last 6 months has received, or is currently receiving, immunosuppression therapy (azathioprine, cyclophosphamide or methotrexate) or any transplant recipient;
• Clinically significant cardiac disease that adversely effects cardiopulmonary function:
• Acute coronary syndromes or active ischemic heart disease (as assessed by the PI using troponin and ECG)
• Cardiac ejection fraction < 40% (if known);
• Need for multiple-dose vasopressors to support blood pressure (single dose vasopressors, such as Levophed™ ≤ 0.1 mcg/kg/min are allowed);
• Cardiogenic pulmonary edema as the etiology of the current respiratory distress;
• Evidence of myocarditis or pericarditis;
• Neuromuscular disease;
• Neutropenia (ANC < 1000);
• Active malignancy that impacts treatment decisions or life expectancy related to the trial;
• Suspected concomitant bacterial or other viral lung infection. Bacterial infection defined as white blood count (WBC) > 15k and positive blood/urine/sputum culture results within 72 hours.