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.
Drug: Lucinactant
Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Other Name: Sinapultide (KL4) Surfactant
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.
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
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
Hospital Italiano de Bueno Aires
Buenos Aires, Argentina
CEMIC - Centro de Educacion Medica e Investigaciones Clinicals
Buenos Aires, Argentina