Status:
COMPLETED
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Windtree Therapeutics
Conditions:
COVID-19
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
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 synt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04389671
Start Date
January 5 2021
End Date
February 20 2022
Last Update
June 23 2023
Active Locations (11)
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1
University California San Diego - Jacobs Medical Center
La Jolla, California, United States, 92037
2
University of California San Diego - Medical Center, Hillcrest
San Diego, California, United States, 92103
3
Augusta University Health
Augusta, Georgia, United States, 30912
4
University of Kentucky
Lexington, Kentucky, United States, 40536