Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lucinactant · 2 trials · 3 indications
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.
Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.
| Arm | Type | Description |
|---|---|---|
| Lyophilized Lucinactant | EXPERIMENTAL | Lyophilized Lucinactant reconstituted with sterile water for injection |
| Lucinactant | EXPERIMENTAL | SURFAXIN® (lucinactant) for intratracheal instillation |
| Sham Air | SHAM_COMPARATOR | Sham air (placebo) instillation |
| Name | Type | Description |
|---|---|---|
| Lucinactant | DRUG | Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered |
| Sham Comparator | OTHER | Slow intra-tracheal instillation |
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 int...