Prevention of COVID-19 Progression Through Early Administration of Inhaled Nitric Oxide.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
研究概览
简要总结
This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.
详细描述
Primary Objective:
• To investigate the hypothesis that inhaled NO will reduce clinical worsening of hospitalized, high-risk patients with early COVID-19 to progressive systemic de-oxygenation, intubation, or death.
Secondary Objectives:
• To investigate the hypothesis that the beneficial effects of inhaled NO occur coincident with a decrease in systemic inflammation in COVID-19.
This is a pilot randomized-controlled (2:1) open label investigation of inhaled NO to prevent progression to more advanced disease in 42 hospitalized patients with COVID-19, at risk for worsening, based on baseline systemic oxygenation and 2 or more of the major risk factors of age > 60 years, type II DM, hypertension, and obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years.
- •Admitted to the hospital (med-surg or critical care) with dyspnea
- •Diagnosis of COVID-19 based on either
- •positive nasal or oral pharyngeal swab by PCR, or
- •highly probable clinical picture based on clinical and CXR/CT scan
- •Requiring oxygen supplementation OR O2 saturation on room air of ≤ 94%
- •At least 2 of the following 4 risk factors for clinical worsening:
- •Age >= 60 years
- •T2DM or pre-diabetes as evidenced by either treatment with a hypoglycemic agent or any documented HgA1c >= 5.6
- •Obesity, based on BMI >= 30 kg/m2
- •Hypertension, based on treatment with an antihypertensive medication or systolic or diastolic blood pressure measurement >= 140 or >= 90 mmHg, documented at enrollment or at any time within the prior 6 months.
排除标准
- •Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 hours.
- •Receiving > 5L/min flow nasal O2 to maintain O2sat greater than or equal to 92%
- •Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV)
- •Receiving iNO, a PDE5 inhibitor, oral or intravenous nitrates, nitroprusside, prilocaine, sulfonamides, or riociguat.
- •Other major pulmonary, cardiac, such as chronic obstructive lung disease or heart failure, or systemic illness or disease involvement with potential to represent the primary driver for clinical deterioration within the next 3 days.
- •History of group 1 pulmonary hypertension.
- •Active breast feeding
- •Severe chronic kidney disease, either receiving renal replacement therapy or eGFR < 15 ml/min/m2
- •Acute kidney injury (AKI), evidenced by acute doubling of serum creatinine within previous 48 hours.
- •Clinically relevant spontaneous alteration of mental state
- •Inability to provide written informed consent.
研究组 & 干预措施
Intervention
Will receive study drug treatment.
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
Number of Participants With Average Maximum Disease Severity Assessed Through 28 Days
时间窗: 28 days
The clinical disease severity was assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization were those with scores of 1 or 2 (below), and randomization was stratified according to score (1 or 2). Study drug began within 1 hour of randomization. Beginning on the day following randomization ("day 1"), we calculated clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM.
次要结局
- Length of Hospital Stay(28 days)
- Mortality(28 days)
- Days to Maximum Clinical Disease Severity Score(28 days)
- Number of Participants in Each Stage at Maximum Severity(28 days)
- Days to Maximum Outcome Severity Score(28 days)