Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Preliminary Efficacy of Lucinactant in Adults With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389671
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
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 1 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 was approved for the prevention of respiratory distress syndrome (RDS) in premature infants. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 Preliminary Efficacy of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Lyophilized Lucinactant
Lyophilized lucinactant reconstituted with 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: KL4 Surfactant




Primary Outcome Measures :
  1. Oxygenation index (OI) area under the curve (AUC)0-12 [ Time Frame: 12 hours post initiation of dosing ]
    The AUC for OI through 12 hours measured using the trapezoidal method, where OI is defined as mean airway pressure (Paw)×fraction of inspired oxygen (FiO2)×100/arterial pressure of oxygen (PaO2)


Secondary Outcome Measures :
  1. FiO2 [ Time Frame: 24 hours post initiation of dosing ]
    FiO2 change from baseline

  2. PaO2 [ Time Frame: 24 hours post initiation of dosing ]
    PaO2 change from baseline

  3. Oxygenation from pulse oximetry (SpO2) [ Time Frame: 24 hours post initiation of dosing ]
    SpO2 change from baseline

  4. P/F ratio [ Time Frame: 24 hours post initiation of dosing ]
    Change from baseline in P/F ratio, defined as PaO2/FiO2

  5. Ventilation Index (VI) [ Time Frame: 24 hours post initiation of dosing ]
    Change from baseline in VI, defined as [respiration rate (RR)×(peak inspriatory pressure [PIP] − peak expiratory end pressure [PEEP])× arterial pressure of carbon dioxide (PaCO2)]/1000

  6. Lung compliance [ Time Frame: 24 hours post initiation of dosing ]
    Change from baseline in lung compliance, as measured by the ventilator



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 ICF;
  • Age 18-75 (inclusive);
  • Real time polymerase chain reaction (rtPCR) assay positive for SARS-CoV-2 virus;
  • Endotracheal intubation and mechanical ventilation (MV);
  • In-dwelling arterial line;
  • P/F ratio < 300;
  • Mean blood pressure ≥ 65 mmHg, with or without vasopressor support, 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, 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 or any transplant recipient;
  • Clinically significant cardiac disease that adversely effects cardiopulmonary function:
  • Acute coronary syndromes or active ischemic heart disease;
  • Cardiac ejection fraction < 40% (if known);
  • Need for multiple-dose vasopressors to support blood pressure;
  • Cardiogenic pulmonary edema as the etiology of the respiratory distress;
  • Evidence of myocarditis or pericarditis;
  • Neuromuscular disease;
  • Neutropenia (absolute neutrophil count < 1000);
  • Active malignancy that impacts treatment decisions or life expectancy related to this trial;
  • Suspected concomitant bacterial or other viral lung infection.

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
Layout table for location contacts
Contact: Phillip D Simmons, MS 215-488-7300 psimmons@windtreetx.com
Contact: Steven G Simonson, MD 215-488-7300 ssimonson@windtreetx.com

Sponsors and Collaborators
Windtree Therapeutics
Investigators
Layout table for investigator information
Principal Investigator: Steven Keller, MD, PhD Brigham & Women's Hospital, Boston, MA
Principal Investigator: Yuh-Chin T Huang, MD, MHS Duke University
Layout table for additonal information
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 15, 2020
Last Verified: May 2020
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.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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