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

NCT ID: NCT04389671

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2022-02-20

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lyophilized Lucinactant

Lyophilized Lucinactant reconstituted with sterile water for injection

Group Type: EXPERIMENTAL

Lucinactant

Intervention Type: DRUG

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

Interventions

Lucinactant

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

Intervention Type: DRUG

Other Intervention Names

Sinapultide (KL4) Surfactant

Eligibility 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Windtree Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuh-Chin T Huang, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Steve G Simonson, MD

Role: STUDY_DIRECTOR

Windtree Therapeutics

Locations

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

Countries

United States; Argentina

References

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.

Reference Type: DERIVED

PMID: 35474746 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34337553 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

02-CL-2001a

Identifier Type: -

Identifier Source: org_study_id