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

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Treatments: Pulmonary Surfactants

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;

• 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, 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:

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.