AzTrials
AzTrials

COVID-19Phase 2NCT04389671

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

A Phase 2 study testing Lucinactant in people with COVID-19 and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Windtree Therapeutics at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Lucinactant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesin 2 countries
Study dates
5 Jan 2021to 20 Feb 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 14Show fewer
  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States7 sites

  • Augusta University Health

    Augusta, Georgia, 30912

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • University California San Diego - Jacobs Medical Center

    La Jolla, California, 92037

  • University of Kentucky

    Lexington, Kentucky, 40536

  • University of California San Diego - Medical Center, Hillcrest

    San Diego, California, 92103

Other trials in United States

Argentina4 sites

  • Fundacion Sanatorio Güemes

    Buenos Aires, C1118

  • Hospital Alemán

    Buenos Aires, C1118

  • Hospital Italiano de Bueno Aires

    Buenos Aires, C119ABB

  • CEMIC - Centro de Educacion Medica e Investigaciones Clinicals

    Buenos Aires

Other trials in Argentina

About this study

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

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.

Read the 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.

Being tested
Lucinactant
Medical subject headings
COVID-19, Acute Lung Injury, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LucinactantDrug

    Also called Sinapultide (KL4) Surfactant

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

Study groups in NCT04389671
Study groupRoleWhat they receive
Lyophilized LucinactantExperimentalLyophilized Lucinactant reconstituted with sterile water for injection
Receives: Drug: Lucinactant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline through 12 hours post initiation of dosing

Secondary outcomes (19)

  1. Fraction of Inspired Oxygen (FiO2)

    Change from baseline in FiO2 measured using mean and standard deviation. FiO2 level, ranging from 0.21 (room air) to 1.00 (i.e., 21% to 100%)

    Measured: Baseline through 24 hours post initiation of dosing

  2. Partial Pressure of Oxygen (PaO2)

    Change from baseline in PaO2 measured using mean and standard deviation

    Measured: Baseline through 24 hours post initiation of dosing

  3. Oxygenation From Pulse Oximetry (SpO2)

    Change from baseline in SpO2 measured using mean and standard deviation

    Measured: Baseline through 24 hours post initiation of dosing

  4. Oxygen Index (OI)

    Change from baseline in OI. OI is an index value, calculated as Paw x FiO2 x 100 / 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.

    Measured: Baseline through 24 hours post initiation of dosing

  5. Partial Pressure of Carbon Dioxide (PaCO2)

    Change from baseline in PaCO2 measured using mean and standard deviation

    Measured: Baseline through 24 hours post initiation of dosing

  6. End Tidal Carbon Dioxide (ETCO2)

    Change from baseline in ETCO2 measured using mean and standard deviation

    Measured: Baseline through 24 hours post initiation of dosing

  7. PaO2 to FiO2 (P/F) Ratio

    Change from baseline in ratio of arterial oxygen concentration to fraction of inspired oxygen (P/F ratio) and/or ratio of pulse oximetric saturation to fraction of inspired oxygen (P/F and/or S/F ratios) measured using mean and standard deviation.

    Measured: Baseline through 24 hours post initiation of dosing

  8. SpO2 to FiO2 (S/F) Ratio

    Change from baseline in ratio of pulse oximetric saturation to fraction of inspired oxygen (S/F ratio) measured using mean and standard deviation.

    Measured: Through 24 hours

  9. Plateau Pressure (PPLAT)

    Change from baseline in PPLAT, as measured on the ventilator, measured using mean and standard deviation.

    Measured: Through 24 Hours

  10. Peak Inspiratory Pressure (PIP)

    Change from baseline in PIP, as measured on the ventilator, measured using mean and standard deviation.

    Measured: Baseline through 24 hours post initiation of dosing

  11. Peak Expiratory End Pressure (PEEP)

    Change from baseline in PEEP, measured using mean and standard deviation.

    Measured: Through 24 hours

  12. Ventilation Index (VI)

    Change from baseline 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 and standard deviation. The VI is used to determine the severity of respiratory illness, with higher values indicating worsening respiratory illness.

    Measured: Baseline through 24 hours post initiation of dosing

  13. Lung Compliance (CL)

    Change from baseline in lung compliance measured using measured using mean and standard deviation.

    Measured: Baseline through 24 hours post initiation of dosing

  14. Daily Lung Compliance (Static) on Ventilator

    Change from baseline in daily lung compliance (static) on ventilator using measured using mean and standard deviation.

    Measured: Baseline through 24 hours post initiation of dosing

  15. Ventilator Free Days

    Ventilator free days measured using mean and standard deviation.

    Measured: Baseline through 30 days post initiation of dosing

  16. Days in the Intensive Care Unit (ICU)

    Days in the intensive care unit (ICU) measured using mean and standard deviation.

    Measured: Baseline through 30 days post initiation of dosing

  17. Days in the Hospital

    Days in the hospital measured using mean and standard deviation.

    Measured: Baseline through 30 days post initiation of dosing

  18. All-cause Mortality

    Number of participant deaths.

    Measured: Baseline through 30 days post initiation of dosing

  19. Organ Failure Free Days

    Organ failure free days measured using mean and standard deviation.

    Measured: Baseline through 30 days post initiation of dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2020
  2. Study start5 Jan 2021
  3. Primary completion20 Feb 2022
  4. Study completion20 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single treatment of reconstituted Lucinactant, delivered as an intratracheal liquid.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04389671
Sponsor's protocol ID
02-CL-2001a
Status last verified
Jun 2023
First submitted
13 May 2020
Last updated
23 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Huang YC, Morris P, Owens R, Guardia C, Keller S, Belloso W, Weinstein L, Simmons P, Simonson S. Lucinactant, a Synthetic Surfactant for the Treatment of Acute Respiratory Distress Syndrome Caused by COVID-19: Phase 1/2A Trial. JMIR Form Res. 2026 Jul 31;10:e77315. doi: 10.2196/77315.

    PubMed 42536986

  • 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.

    PubMed 35474746

  • 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.

    PubMed 34337553

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lucinactant in people with COVID-19 and Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), run by Windtree Therapeutics at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Index (OI) (time frame: Baseline through 12 hours post initiation of dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04389671, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in