The Safety and Preliminary Efficacy of Lucinactant in Adults With COVID-19
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|ClinicalTrials.gov Identifier: NCT04389671|
Recruitment Status : Not yet recruiting
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)||Drug: Lucinactant||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single treatment of reconstituted lucinactant, delivered as an intratracheal liquid.|
|Masking:||None (Open Label)|
|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|
Experimental: Lyophilized Lucinactant
Lyophilized lucinactant reconstituted with water for injection
Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Other Name: KL4 Surfactant
- 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)
- FiO2 [ Time Frame: 24 hours post initiation of dosing ]FiO2 change from baseline
- PaO2 [ Time Frame: 24 hours post initiation of dosing ]PaO2 change from baseline
- Oxygenation from pulse oximetry (SpO2) [ Time Frame: 24 hours post initiation of dosing ]SpO2 change from baseline
- P/F ratio [ Time Frame: 24 hours post initiation of dosing ]Change from baseline in P/F ratio, defined as PaO2/FiO2
- 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
- Lung compliance [ Time Frame: 24 hours post initiation of dosing ]Change from baseline in lung compliance, as measured by the ventilator
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
|Contact: Phillip D Simmons, MSemail@example.com|
|Contact: Steven G Simonson, MDfirstname.lastname@example.org|
|Principal Investigator:||Steven Keller, MD, PhD||Brigham & Women's Hospital, Boston, MA|
|Principal Investigator:||Yuh-Chin T Huang, MD, MHS||Duke University|