A Multicenter, Single-Treatment Study to Assess the Safety and Tolerability of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- Oxygen Index (OI)
研究概览
简要总结
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.
详细描述
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, in its liquid form (SURFAXIN®), is approved by the United States Food and Drug Administration (NDA 021746) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 < 300;
- •Mean blood pressure ≥ 65 mmHg, immediately before enrollment;
- •Bilateral infiltrates seen on frontal chest radiograph.
排除标准
- •Life expectancy < 48 hours or do not resuscitate orders;
- •Severe lung disease (home O2, forced expiratory volume at one second [FEV1] < 2 liters) not likely to respond to therapy or profound hypoxemia (ie, oxygen index [OI] ≥ 25 or P/F ratio < 100);
- •Severe renal impairment (creatinine clearance < 30 mL/min);
- •Within the last 6 months has received, or is currently receiving, immunosuppression therapy (azathioprine, cyclophosphamide or methotrexate) or any transplant recipient;
- •Clinically significant cardiac disease that adversely effects cardiopulmonary function:
- •Acute coronary syndromes or active ischemic heart disease (as assessed by the PI using troponin and ECG)
- •Cardiac ejection fraction < 40% (if known);
- •Need for multiple-dose vasopressors to support blood pressure (single dose vasopressors, such as Levophed™ ≤ 0.1 mcg/kg/min are allowed);
- •Cardiogenic pulmonary edema as the etiology of the current respiratory distress;
- •Evidence of myocarditis or pericarditis;
- •Neuromuscular disease;
- •Neutropenia (ANC < 1000);
- •Active malignancy that impacts treatment decisions or life expectancy related to the trial;
- •Suspected concomitant bacterial or other viral lung infection. Bacterial infection defined as white blood count (WBC) > 15k and positive blood/urine/sputum culture results within 72 hours.
研究组 & 干预措施
Lyophilized Lucinactant
Lyophilized Lucinactant reconstituted with sterile water for injection
干预措施: Lucinactant (Drug)
结局指标
主要结局
Oxygen Index (OI)
时间窗: Baseline through 12 hours post initiation of dosing
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.
次要结局
- End Tidal Carbon Dioxide (ETCO2)(Baseline through 24 hours post initiation of dosing)
- Days in the Hospital(Baseline through 30 days post initiation of dosing)
- Partial Pressure of Carbon Dioxide (PaCO2)(Baseline through 24 hours post initiation of dosing)
- Oxygenation From Pulse Oximetry (SpO2)(Baseline through 24 hours post initiation of dosing)
- Oxygen Index (OI)(Baseline through 24 hours post initiation of dosing)
- Fraction of Inspired Oxygen (FiO2)(Baseline through 24 hours post initiation of dosing)
- Peak Expiratory End Pressure (PEEP)(Through 24 hours)
- Daily Lung Compliance (Static) on Ventilator(Baseline through 24 hours post initiation of dosing)
- Partial Pressure of Oxygen (PaO2)(Baseline through 24 hours post initiation of dosing)
- PaO2 to FiO2 (P/F) Ratio(Baseline through 24 hours post initiation of dosing)
- SpO2 to FiO2 (S/F) Ratio(Through 24 hours)
- Plateau Pressure (PPLAT)(Through 24 Hours)
- Ventilator Free Days(Baseline through 30 days post initiation of dosing)
- Days in the Intensive Care Unit (ICU)(Baseline through 30 days post initiation of dosing)
- All-cause Mortality(Baseline through 30 days post initiation of dosing)
- Peak Inspiratory Pressure (PIP)(Baseline through 24 hours post initiation of dosing)
- Ventilation Index (VI)(Baseline through 24 hours post initiation of dosing)
- Lung Compliance (CL)(Baseline through 24 hours post initiation of dosing)
- Organ Failure Free Days(Baseline through 30 days post initiation of dosing)