NCT04456088撤回2 期
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Time to deterioration
研究概览
简要总结
The purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm Nitric Oxide given in addition to the standard of care of patients with COVID-19 caused by SARS-CoV-2.
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
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male and female) admitted to the hospital for COVID-19
- •Patients with oxygen saturation less than 93 % on room air
- •Shortness of breath, with symptom onset within the previous 8 days.
- •Ability to understand and comply with study requirements .
- •Signed informed consent by subject
排除标准
- •Patients who are treated with or require high flow nasal cannula, CPAP, intubation, mechanical ventilation, or tracheostomy
- •Diagnosis of acute respiratory distress syndrome
- •Breastfeeding or pregnancy as evidenced by a positive pregnancy test.
- •Subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction (LVEF <40%) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension
- •History of frequent epistaxis (>1 episode/month).
- •Significant hemoptysis during the last 30 days prior to enrollment
- •Methemoglobin level >3% at screening
- •Patients on systemic steroids (any formulation) within 30 days prior to enrollment.
- •History of daily, continuous oxygen supplementation
- •Patients with BMI greater than or equal to 36
- •Patient receiving drugs that have a contraindication with NO,
- •Patients with clinically significant anemia, e.g., Hb <100 g/L and thrombocytopenia, e.g., Platelets <75 thousand cells/mcL.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data, e.g., known or suspected thalassemia, sickle cell disease or other diseases associated with poor oxygen carrying capacity.
- •The subject is identified by the investigator as being unable or unwilling to perform study procedures.
结局指标
主要结局
Time to deterioration
时间窗: up to 14 days
Time to deterioration as measured by any one of the following: * need for non-invasive ventilation * need for high flow nasal cannula (HFNC) or * need for intubation * Death from any cause
次要结局
- Time to stable oxygen saturation(up to 14 days)
研究者
相似试验
终止
不适用
Inhaled NO for the Treatment of COVID-19 Caused by SARS-CoV-2 (US Trial)Corona Virus InfectionCOVID-19SARS-CoV 2Nitric OxideRespiratory DiseasePneumonia, ViralInhaled Nitric OxideNCT04397692Beyond Air Inc.4
进行中（未招募）
2 期
A Nasal Treatment for COVID-19COVID-19NCT05799521Indiana University24
招募中
2 期
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled AerosolCOVID-19 InfectionNCT06381739McMaster University350
尚未招募
2 期
se of Steroid inhalers in COVID.CTRI/2021/05/033817YOU BREATHE WE CARE
已完成
2 期
A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial InfectionNontuberculous Mycobacterium InfectionNCT03748992Medical University of South Carolina10