Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04389671 | The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 20 | — | — | Jan 5, 2021 | Feb 20, 2022 | Jun 23, 2023 | 11 | United States, Argentina |
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.
| Arm | Type | Description |
|---|---|---|
| Lyophilized Lucinactant | EXPERIMENTAL | Lyophilized Lucinactant reconstituted with sterile water for injection |
| Name | Type | Description |
|---|---|---|
| Lucinactant | DRUG | Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered |
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...