Nitric Oxide Inhalation Therapy for COVID-19 Infections in the Emergency Department
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Rates of return visits to the ED
研究概览
简要总结
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains. The primary aim of this study is to determine whether inhaled NO improves short term respiratory status, prevents future hospitalization, and improves the clinical course in patients diagnosed with COVID-19 specifically in the emergency department.
详细描述
The spread of novel Coronavirus (2019-nCoV) related infection (COVID-19) has led to many patient presentations in the emergency department for respiratory complaints, with many of these patients requiring ICU admission and ventilatory support. While COVID-19 patients have an increased need for supportive care, there is currently no specific treatment directed against 2019-nCoV. Nitric oxide inhalation has been used as a pulmonary vasodilator and has been found to have antiviral activity against other coronavirus strains.
Preliminary data support a microbicidal effect of high concentration inhaled NO. We hypothesize that high concentration inhaled NO can have a viricidal effect against SARS-Cov-2 and prevent the deterioration to a severe form of COVID-19 when administered at an early stage of the disease. Additional potential mechanisms why INO may be effective in this indication: 1)improves V/Q ratio, 2) reduces PVR and PAP, 3) Anti-thrombotic in lung. This would have potential benefit for the patients in terms of reducing the severity of the clinical course and time to recovery. An additional benefit could be for the society since a faster and a less severe clinical course could protect limited hospital resources (ED, floor, and ICU) from being overwhelmed.
The primary aim is to prevent the deterioration of mild COVID-19 infection (defined by a RT-PCR positive for SARS-CoV-2 in a specimen from any site) with respiratory signs/ symptoms to a more severe form of the disease as defined by the patient needing to 1) return to the ED, 2) be admitting to the hospital, 3) be intubated, 4) and all cause 28 day mortality.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Presentation to the ED with respiratory symptoms likely caused by COVID-19
- •Patient displays at least one of the following
- •respiratory rate ≥ 24
- •new atypical chest pain
- •new dyspnea
- •oxygen saturation < 97% at rest
- •chest x-ray with new changes consistent with COVID-related airspace disease
- •Cleared for discharge home by attending physician
- •Obtained COVID testing (results not required at time of enrollment)
- •Onset of symptoms ≤12 days prior to ED visit
排除标准
- •Attending physician estimation (< 50% likelihood) of other more likely non-COVID etiology
- •Presence of tracheostomy
- •Requirement of oxygen therapy to maintain resting oxygen saturation of > 94%
- •Clinical contraindication to use of inhaled nitric oxide
研究组 & 干预措施
Treatment Group
Inhaled nitric oxide
干预措施: Nitric Oxide Gas (Drug)
Control Group
Inhaled supplemental oxygen
干预措施: Inhaled Supplemental Oxygen (Other)
结局指标
主要结局
Rates of return visits to the ED
时间窗: 28 days
Difference within treatment and control groups with COVID-related symptoms/disease in their likelihood to return to the ED with worsening symptoms
次要结局
- Inpatient hospitalizations required(28 days)
- Rates of intubation(28 days)
- Rates of mortality(28 days)
研究者
N. Stuart Harris MD MFA
Principal Investigator, Division Chief of Wilderness Medicine, Department of Emergency Medicine
Massachusetts General Hospital