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

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ClinicalTrials.gov Identifier: NCT04389671
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : May 7, 2021
Sponsor:
Information provided by (Responsible Party):
Windtree Therapeutics

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.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) Drug: Lucinactant Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Lyophilized Lucinactant
Lyophilized Lucinactant reconstituted with sterile water for injection
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




Primary Outcome Measures :
  1. Evaluate the safety and feasibility of Lucinactant surfactant replacement therapy (SRT) in treating COVID-19 [ Time Frame: (OI) through 12 hours post dosing and other physiological and outcome measurements through 24 hours or through Day 30 ]
    The oxygen index (OI), where OI is defined as (Mean Airway Pressure [Paw]) x (Fraction of Inspired Oxygen [FiO2]) x (100) / (Partial Pressure of Oxygen [PaO2]), and other physiological and outcome measurements

  2. Oxygen index (OI) [ Time Frame: Baseline through 12 hours post initiation of dosing ]
    Change in OI, where OI is defined as (Mean Airway Pressure [Paw]) x (Fraction of Inspired Oxygen [FiO2]) x (100) / (Partial Pressure of Oxygen [PaO2])


Secondary Outcome Measures :
  1. Fraction of inspired oxygen (FiO2) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in FiO2 measured using mean, standard deviation (SD), median, minimum, and maximum

  2. Partial pressure of oxygen (PaO2) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in PaO2 measured using mean, SD, median, minimum, and maximum

  3. Oxygenation from pulse oximetry (SpO2) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in SpO2 measured using mean, SD, median, minimum, and maximum

  4. Oxygen index (OI) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in OI, defined as (Mean Airway Pressure [Paw]) x (Fraction of Inspired Oxygen [FiO2]) x (100)/(Partial Pressure of Oxygen [PaO2]) measured using mean, SD, median, minimum, and maximum

  5. Partial pressure of carbon dioxide (PaCO2) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in PaCO2 measured using mean, SD, median, minimum, and maximum

  6. End tidal carbon dioxide (ETCO2) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in ETCO2 measured using mean, SD, median, minimum, and maximum

  7. Ratio of arterial oxygen concentration to fraction of inspired oxygen and/or ratio of pulse oximetric saturation to fraction of inspired oxygen (P/F and/or S/F ratios) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in P/F and/or S/F ratios measured using mean, SD, median, minimum, and maximum

  8. Plateau pressure and peak inspiratory pressure (PPLAT and PIP) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in PPLAT and PIP, as measured on the ventilator, measured using mean, SD, median, minimum, and maximum

  9. Ventilation Index (VI) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in VI, defined as (Respiration Rate [RR]) × (Peak Inspiratory Pressure [PIP] - Positive End Expiratory Pressure [PEEP]) × (Partial Pressure of Arterial Carbon Dioxide (PaCO2)] / (1000) measured using mean, SD, median, minimum, and maximum

  10. Lung compliance (CL) [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in lung compliance measured using mean, SD, median, minimum, and maximum

  11. Pressure-volume loops, if ventilator technology permits [ Time Frame: Baseline through 24 hours post initiation of dosing ]
    Change in pressure-volume loops

  12. Daily lung compliance (static) on ventilator [ Time Frame: Baseline through 30 days post initiation of dosing ]
    Change in daily lung compliance (static) on ventilator using mean, standard deviation (SD), median, minimum, and maximum

  13. Ventilator free days [ Time Frame: Baseline through 30 days post initiation of dosing ]
    Change in ventilator free days using mean, SD, median, minimum, and maximum

  14. Days in the intensive care unit (ICU) [ Time Frame: Baseline through 30 days post initiation of dosing ]
    Change in days in the intensive care unit (ICU) using mean, standard deviation (SD), median, minimum, and maximum

  15. Days in the hospital [ Time Frame: Baseline through 30 days post initiation of dosing ]
    Change in days in the hospital using mean, SD, median, minimum, and maximum

  16. Incidence of all-cause mortality [ Time Frame: Baseline through 30 days post initiation of dosing ]
    All-cause mortality using mean, SD, median, minimum, and maximum

  17. Organ failure free days [ Time Frame: Baseline through 30 days post initiation of dosing ]
    Organ failure free days using mean, SD, median, minimum, and maximum



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389671


Contacts
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Contact: Catherine Kacprzycki, BSN 215-488-9478 ckacprzycki@windtreetx.com
Contact: Steven G Simonson, MD 215-488-9300 ssimonson@windtreetx.com

Locations
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United States, California
University California San Diego - Jacobs Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Ashna Aggarwal       asaggarwal@health.ucsd.edu   
Principal Investigator: Robert Owens, MD         
University of California San Diego - Medical Center, Hillcrest Recruiting
San Diego, California, United States, 92103
Contact: Ashna Aggarwal       asaggarwal@health.ucsd.edu   
Principal Investigator: Robert Owens, MD         
United States, Georgia
Augusta University Health Recruiting
Augusta, Georgia, United States, 30912
Contact: Linda Jones    706-721-5636    LINJONES1@augusta.edu   
United States, Massachusetts
Brigham and Womens Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Brittany McDowell    919-613-6833    brittany.mcdowell@duke.edu   
Sponsors and Collaborators
Windtree Therapeutics
Investigators
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Principal Investigator: Steven Keller, MD, PhD Brigham & Women's Hospital, Boston, MA
Principal Investigator: Yuh-Chin T Huang, MD, MHS Duke University
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Responsible Party: Windtree Therapeutics
ClinicalTrials.gov Identifier: NCT04389671    
Other Study ID Numbers: 02-CL-2001a
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

The preparation and submittal for publication of a manuscript containing the study results shall be in accordance with a process determined by a mutual written agreement among Windtree and participating institutions.

The publication or presentation of any study results shall comply with all applicable privacy laws, including but not limited to HIPAA. This trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted. In addition, every attempt will be made to publish results in peer-reviewed journals.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Pulmonary Surfactants
Respiratory System Agents