The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
Condition: COVID-19; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
Intervention: Lucinactant
Intervention description: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multicenter, single-treatment study. Subjects will consist of adults with COVID-19
      associated acute lung injury who are being cared for in a critical care environment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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;

          -  PaO2/FiO2 (P/F) ratio < 300;

          -  Mean blood pressure ≥ 65 mmHg, immediately before enrollment;

          -  Bilateral infiltrates seen on frontal chest radiograph.

        Exclusion Criteria:

          -  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, oxygen index [OI]
             ≥ 25 or P/F ratio < 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:

               1. Acute coronary syndromes or active ischemic heart disease (as assessed by the PI
                  using troponin and ECG)

               2. Cardiac ejection fraction < 40% (if known);

               3. Need for multiple-dose vasopressors to support blood pressure (single dose
                  vasopressors, such as Levophed™ ≤ 0.1 mcg/kg/min are allowed);

               4. Cardiogenic pulmonary edema as the etiology of the current respiratory distress;

               5. 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.