Phase 2
Completed N=20
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)
COVID · Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Source: ClinicalTrials.gov NCT04389671 ↗
Enrolled (actual)
20
Serious AEs
42.1%
Results posted
Jun 2023
Primary outcomePrimary: Oxygen Index (OI) — -0.91 index
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Index (OI) |
-1.46 | — |
| SECONDARY Fraction of Inspired Oxygen (FiO2) |
-0.05 | — |
| SECONDARY Partial Pressure of Oxygen (PaO2) |
-2.0 | — |
| SECONDARY Oxygenation From Pulse Oximetry (SpO2) |
-0.4 | — |
| SECONDARY Oxygen Index (OI) |
-1.46 | — |
| SECONDARY Partial Pressure of Carbon Dioxide (PaCO2) |
-3.6 | — |
| SECONDARY End Tidal Carbon Dioxide (ETCO2) |
-1.6 | — |
| SECONDARY PaO2 to FiO2 (P/F) Ratio |
-3.87 | — |
| SECONDARY SpO2 to FiO2 (S/F) Ratio |
15.35 | — |
| SECONDARY Plateau Pressure (PPLAT) |
0.5 | — |
| SECONDARY Peak Inspiratory Pressure (PIP) |
-1.0 | — |
| SECONDARY Peak Expiratory End Pressure (PEEP) |
-0.1 | — |
| SECONDARY Ventilation Index (VI) |
-3.75 | — |
| SECONDARY Lung Compliance (CL) |
9.59 | — |
| SECONDARY Daily Lung Compliance (Static) on Ventilator |
2.83 | — |
| SECONDARY Ventilator Free Days |
10.3 | — |
| SECONDARY Days in the Intensive Care Unit (ICU) |
18.6 | — |
| SECONDARY Days in the Hospital |
21.9 | — |
| SECONDARY All-cause Mortality |
7 | — |
| SECONDARY Organ Failure Free Days |
5.7 | — |
Eligibility Criteria
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 intubation and mechanical ventilation (MV), within 7 days of initial intubation;
- In-dwelling arterial line;
- PaO2/FiO2 (P/F) ratio 15k and positive blood/urine/sputum culture results within 72 hours.
Data sourced from ClinicalTrials.gov (NCT04389671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.