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

NCT04389671 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 02-CL-2001a
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 11

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.

Conditions

COVID-19; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Oxygen Index (OI)

  Change from baseline in OI. OI is an index value, calculated as (Mean Airway Pressure \[Paw\]) x (Fraction of Inspired Oxygen \[FiO2\]) x (100) / (Partial Pressure of Oxygen \[PaO2\]) measured using mean and standard deviation. It is a calculation that measures the fraction of inspired oxygen and its usage within the body, and a lower value is better. Values can range from 0 to 1000; values under 25 are correspond with a good outcome.

  Baseline through 12 hours post initiation of dosing

Secondary Outcomes (19)

• Fraction of Inspired Oxygen (FiO2)

  Baseline through 24 hours post initiation of dosing

• Partial Pressure of Oxygen (PaO2)

  Baseline through 24 hours post initiation of dosing

• Oxygenation From Pulse Oximetry (SpO2)

  Baseline through 24 hours post initiation of dosing

• Oxygen Index (OI)

  Baseline through 24 hours post initiation of dosing

• Partial Pressure of Carbon Dioxide (PaCO2)

  Baseline through 24 hours post initiation of dosing

Study Arms (1)

Lyophilized Lucinactant

EXPERIMENTAL

Lyophilized Lucinactant reconstituted with sterile water for injection

Drug: Lucinactant

Interventions

Lucinactant DRUG

Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered

Also known as: Sinapultide (KL4) Surfactant

Lyophilized Lucinactant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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, 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.

Sponsors & Collaborators

• Windtree Therapeutics: lead

Study Sites (11)

University California San Diego - Jacobs Medical Center

La Jolla, California, 92037, United States

Location

University of California San Diego - Medical Center, Hillcrest

San Diego, California, 92103, United States

Location

Augusta University Health

Augusta, Georgia, 30912, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Fundacion Sanatorio Güemes

Buenos Aires, C1118, Argentina

Location

Hospital Alemán

Buenos Aires, C1118, Argentina

Location

Hospital Italiano de Bueno Aires

Buenos Aires, C119ABB, Argentina

Location

CEMIC - Centro de Educacion Medica e Investigaciones Clinicals

Buenos Aires, Argentina

Location

Related Publications (2)

• Lee CK, Merriam LT, Pearson JC, Lipnick MS, McKleroy W, Kim EY. Treating COVID-19: Evolving approaches to evidence in a pandemic. Cell Rep Med. 2022 Feb 9;3(3):100533. doi: 10.1016/j.xcrm.2022.100533. eCollection 2022 Mar 15.

  PMID: 35474746 DERIVED

• Cohen CL, Walker KH, Hsiang M, Sonenthal PD, Riviello ED, Rouhani SA, Lipnick MS, Merriam LT, Kim EY. Combating information chaos: a case for collaborative clinical guidelines in a pandemic. Cell Rep Med. 2021 Aug 17;2(8):100375. doi: 10.1016/j.xcrm.2021.100375. Epub 2021 Jul 27.

  PMID: 34337553 DERIVED

MeSH Terms

Conditions

COVID-19; Acute Lung Injury; Respiratory Distress Syndrome

Interventions

lucinactant; sinapultide; Surface-Active Agents

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Respiration Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Limitations and Caveats

Small number of subjects. No control group.

Results Point of Contact

• Title: Executive Director of Biostatistics & Data Management
• Organization: Windtree Therapeutics, Inc.

psimmons@windtreetx.com

215-488-9300

Study Officials

• Yuh-Chin T Huang, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

• Steve G Simonson, MD

  Windtree Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 15, 2020
• Study Start: January 5, 2021
• Primary Completion: February 20, 2022
• Study Completion: February 20, 2022
• Last Updated: June 23, 2023
• Results First Posted: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); AR (4)