A Multicenter, Single-Treatment Study to Assess the Safety and Tolerability of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury

02-CL-2001a

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.

2021-01-05

2022-02-20

2022-02-20

Completed

Early phase I

20

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

2023-06-23