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

Windtree Therapeutics20 enrolled

Overview

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.

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. Lucinactant is a synthetic surfactant that, in its liquid form (SURFAXIN®), is approved by the United States Food and Drug Administration (NDA 021746) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. It has been studied in over 2000 children and adults. Preliminary data from animal and adult human studies indicate that lucinactant may be able to benefit those with acute respiratory distress syndrome (ARDS) in the context of COVID-19 infection, improving oxygenation and lung compliance. When given to intubated patients, Lucinactant could potentially decrease the duration of ventilation. Lucinactant has an extensive safety profile in different patient populations for different indications. It is hypothesized that lucinactant may improve the respiratory status of patients suffering from COVID-19.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Interventions

LucinactantDRUG

Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (11)

University California San Diego - Jacobs Medical Center

La Jolla, California, United States

University of California San Diego - Medical Center, Hillcrest

San Diego, California, United States

Augusta University Health

Augusta, Georgia, United States

Outcomes

Primary Outcomes

Oxygen Index (OI)

Change from baseline in OI. OI is an index value, calculated as (Mean Airway Pressure \[Paw\]) x (Fraction of Inspired Oxygen \[FiO2\]) x (100) / (Partial Pressure of Oxygen \[PaO2\]) measured using mean and standard deviation. It is a calculation that measures the fraction of inspired oxygen and its usage within the body, and a lower value is better. Values can range from 0 to 1000; values under 25 are correspond with a good outcome.

Time frame: Baseline through 12 hours post initiation of dosing

Secondary Outcomes

Fraction of Inspired Oxygen (FiO2)

Change from baseline in FiO2 measured using mean and standard deviation. FiO2 level, ranging from 0.21 (room air) to 1.00 (i.e., 21% to 100%)

Time frame: Baseline through 24 hours post initiation of dosing

Partial Pressure of Oxygen (PaO2)

Change from baseline in PaO2 measured using mean and standard deviation

Time frame: Baseline through 24 hours post initiation of dosing

Oxygenation From Pulse Oximetry (SpO2)

Change from baseline in SpO2 measured using mean and standard deviation

Time frame: Baseline through 24 hours post initiation of dosing

Oxygen Index (OI)

Change from baseline in OI. OI is an index value, calculated as Paw x FiO2 x 100 / PaO2, measured using mean and standard deviation. It is a calculation that measures the fraction of inspired oxygen and its usage within the body, and a lower value is better. Values can range from 0 to 1000; values under 25 are correspond with a good outcome.

Time frame: Baseline through 24 hours post initiation of dosing

Partial Pressure of Carbon Dioxide (PaCO2)

Data from ClinicalTrials.gov

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