Trial Outcomes & Findings for The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) (NCT NCT04389671)

NCT ID: NCT04389671

Last Updated: 2023-06-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline through 12 hours post initiation of dosing
• Results posted on: 2023-06-23

Participant Flow

First participant enrolled: 05 January 2021 Last participant completed: 20 February 2022 Enrollment occurred in hospital

No wash-out or run-in

Participant milestones

Measure	Lyophilized Lucinactant Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Overall Study STARTED	20
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Lyophilized Lucinactant Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Overall Study Death	7

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	47.5 years STANDARD_DEVIATION 13.69 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Argentina	2 participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Oxygen Index	10.7 index STANDARD_DEVIATION 6.17 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline through 12 hours post initiation of dosing

Population: All participants that received study medication

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.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Oxygen Index (OI)	-0.91 index Standard Deviation 3.14

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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%)

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Fraction of Inspired Oxygen (FiO2)	-0.05 fraction of oxygen Standard Deviation 0.230

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

Change from baseline in PaO2 measured using mean and standard deviation

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Partial Pressure of Oxygen (PaO2)	-2.0 mmHg Standard Deviation 27.63

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

Change from baseline in SpO2 measured using mean and standard deviation

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Oxygenation From Pulse Oximetry (SpO2)	-0.4 percent of blood oxygen saturation Standard Deviation 4.36

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Oxygen Index (OI)	-1.46 index Standard Deviation 5.328

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

Change from baseline in PaCO2 measured using mean and standard deviation

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Partial Pressure of Carbon Dioxide (PaCO2)	-3.6 mmHg Standard Deviation 10.37

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

Change from baseline in ETCO2 measured using mean and standard deviation

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
End Tidal Carbon Dioxide (ETCO2)	-1.6 mmHg Standard Deviation 4.88

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
PaO2 to FiO2 (P/F) Ratio	-3.87 ratio Standard Deviation 71.26

SECONDARY outcome

Timeframe: Through 24 hours

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
SpO2 to FiO2 (S/F) Ratio	15.35 ratio Standard Deviation 65.32

SECONDARY outcome

Timeframe: Through 24 Hours

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Plateau Pressure (PPLAT)	0.5 cm H2O Standard Deviation 3.36

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Peak Inspiratory Pressure (PIP)	-1.0 cm H2O Standard Deviation 4.92

SECONDARY outcome

Timeframe: Through 24 hours

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Peak Expiratory End Pressure (PEEP)	-0.1 cm H2O Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Ventilation Index (VI)	-3.75 index Standard Deviation 15.479

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Lung Compliance (CL)	9.59 mL/cm H2O Standard Deviation 25.251

SECONDARY outcome

Timeframe: Baseline through 24 hours post initiation of dosing

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Daily Lung Compliance (Static) on Ventilator	2.83 mL/cm H2O Standard Deviation 14.176

SECONDARY outcome

Timeframe: Baseline through 30 days post initiation of dosing

Population: All participants that received study medication

Ventilator free days measured using mean and standard deviation.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Ventilator Free Days	10.3 Days Standard Deviation 12.07

SECONDARY outcome

Timeframe: Baseline through 30 days post initiation of dosing

Population: All participants that received study medication

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

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Days in the Intensive Care Unit (ICU)	18.6 Days Standard Deviation 9.41

SECONDARY outcome

Timeframe: Baseline through 30 days post initiation of dosing

Population: All participants that received study medication

Days in the hospital measured using mean and standard deviation.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Days in the Hospital	21.9 Days Standard Deviation 8.31

SECONDARY outcome

Timeframe: Baseline through 30 days post initiation of dosing

Population: All participants that received study medication

Number of participant deaths.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
All-cause Mortality	7 Participants

SECONDARY outcome

Timeframe: Baseline through 30 days post initiation of dosing

Population: All participants that received study medication

Organ failure free days measured using mean and standard deviation.

Outcome measures

Measure	Lyophilized Lucinactant n=19 Participants Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Organ Failure Free Days	5.7 Days Standard Deviation 6.44

Adverse Events

Lyophilized Lucinactant

Serious events: 8 serious events

Other events: 16 other events

Deaths: 7 deaths

Serious adverse events

Measure	Lyophilized Lucinactant n=19 participants at risk Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Cardiac disorders Atrial fibrillation	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Cardiac disorders Cardiac arrest	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
General disorders Multiple organ dysfunction syndrome	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Bacteraemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations COVID-19 pneumonia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Fungaemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Pneumonia pneumococcal	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Sepsis	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Septic Shock	10.5% 2/19 • Number of events 2 • Enrollment to 30 days after enrollment
Infections and infestations Staphylococcal infection	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pneumonia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pneumonia staphylococcal	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Surgical and medical procedures	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Lung assist device therapy	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment

Other adverse events

Measure	Lyophilized Lucinactant n=19 participants at risk Lyophilized Lucinactant reconstituted with sterile water for injection Lucinactant: Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
Blood and lymphatic system disorders Eosinophilia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Blood and lymphatic system disorders Thrombocytopenia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Cardiac disorders Bradycardia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Cardiac disorders Cardiac failure	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Gastrointestinal disorders Retching	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
General disorders Pyrexia	10.5% 2/19 • Number of events 2 • Enrollment to 30 days after enrollment
Infections and infestations Bronchopulmonary aspergillosis	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Fungaemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Infections and infestations Sepsis	10.5% 2/19 • Number of events 2 • Enrollment to 30 days after enrollment
Infections and infestations Septic shock	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Investigations Blood gases abnormal	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Investigations Oxygen saturation decreased	15.8% 3/19 • Number of events 3 • Enrollment to 30 days after enrollment
Investigations Staphylococcus test positive	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hyperglycemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hypernatraemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hypokalaemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hypomagnesaemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hyponatraemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Metabolism and nutrition disorders Hypophosphataemia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Renal and urinary disorders Urinary retention	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Dysphonia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Hypercapnia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pneumonia staphylococcal	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pneumothorax	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Respiratory, thoracic and mediastinal disorders Pulmonary mass	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Vascular disorders Deep vein thrombosis	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Vascular disorders Hypertension	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Vascular disorders Hypotension	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Vascular disorders Pulmonary embolism	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment
Vascular disorders Thrombophlebitis superficial	5.3% 1/19 • Number of events 1 • Enrollment to 30 days after enrollment

Additional Information

Executive Director of Biostatistics & Data Management

Windtree Therapeutics, Inc.

Phone: 215-488-9300

Email: psimmons@windtreetx.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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. Every attempt will be made to publish results in peer-reviewed journals.
• Publication restrictions are in place

Restriction type: OTHER