Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Robert Owens, MD (ucsd)
Photo of Robert Owens
Robert Owens

Description

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.

Official Title

A Multicenter, Single-Treatment Study to Assess the Safety and Tolerability of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury

Details

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.

Keywords

COVID-19 Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Pulmonary Surfactants Lucinactant Lyophilized Lucinactant

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join 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, 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:
  • 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.

Locations

  • University California San Diego - Jacobs Medical Center accepting new patients
    La Jolla California 92037 United States
  • University of California San Diego - Medical Center, Hillcrest accepting new patients
    San Diego California 92103 United States

Lead Scientist at University of California Health

  • Robert Owens, MD (ucsd)
    Associate Professor, Medicine. Authored (or co-authored) 116 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Windtree Therapeutics
ID
NCT04389671
Phase
Phase 2
Study Type
Interventional
Last Updated