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

Completed · Phase 2

Conditions studied: COVID-19, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

In brief

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.

Key facts

Study ID

NCT04389671

Run by

Windtree Therapeutics

People needed

20

Starts

2021-01-05

Expected to finish

2022-02-20

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• 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.

Where it is running

• Augusta University Health — Augusta, Georgia, United States
• University of Kentucky — Lexington, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Fundacion Sanatorio Güemes — Buenos Aires, Argentina
• Hospital Alemán — Buenos Aires, Argentina
• University California San Diego - Jacobs Medical Center — La Jolla, California, United States
• Hospital Italiano de Bueno Aires — Buenos Aires, Argentina
• University of California San Diego - Medical Center, Hillcrest — San Diego, California, United States
• CEMIC - Centro de Educacion Medica e Investigaciones Clinicals — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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