Extended Compassionate Use Program (UCA) With Inhalational Ibuprofen in Patients With Acute Respiratory Pathology, Mediated by COVID-19.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.
研究概览
简要总结
The study aims to evaluate the reduction in severity and progression of lung injury with inhaled ibuprofen in patients with severe acute respiratory syndrome due to SARS-CoV-2 virus.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent by the patient OR by the patient's Legal Representative.
- •Confirmed or suspected SARS-CoV-2 infection;
- •Pneumonia without criteria of severity.
- •With some of the following conditions:
- •Diabetes.
- •Cardiovascular disease.
- •Chronic kidney disease.
- •Chronic obstructive pulmonary disease.
- •Structural diseases of the lung
- •Immunocompromise.
- •Patient who presents negative results by rtPCR for SARS CoV-2, in case of being highly suspicious, the patient may receive it empirically until the results are obtained.
- •No unstable bronchial asthma
排除标准
- •The doctor considers that participation in the Program is not the best for patients or for any condition that prevents the Program from being followed safely.
- •Patients with a history of unstable bronchial asthma
- •The patient is allergic to ibuprofen or any of the compounds in the preparation.
- •Hypersensitivity to the drug, nasal polyps syndrome, angioedema or bronchospasm against aspirin or other NSAIDs.
- •Pregnant or lactating woman, or positive pregnancy test on a pre-dose exam.
- •Patient who is expected to be transferred to another place other than the place where the Program starts, within 7 days of starting it.
研究组 & 干预措施
Luarprofen
Inhaled Hypertonic ibuprofen 50 mg tid
干预措施: Inhaled Hypertonic ibuprofen (Drug)
结局指标
主要结局
Change to Negativization of the swab to the following treatment points on day 7, day 14, 21 and 28 after treatment with inhaled Ibuprofen.
时间窗: 7, 14 and 28 days
Negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Change in the scale of ordinary COVID results at 7, 14 and 28 days in patients with acute respiratory infection, induced by SARS-CoV-2, treated with inhaled Ibuprofen.
时间窗: 7, 14 and 28 days
Time to clinical improvement: defined as time from inhaled Ibuprofen first dose to an improvement of three points from the status on a seven-category ordinary scale
次要结局
- Incidence of adverse event(28 days)
- Chage in length of Hospital stay(28 days)
- Average score of National Early Warning (NEWS2) between days 1, 7, 14 and 28.(1, 7, 14 and 28)
- Glucocorticoids requirement(28 days)
- Chage in duration of ventilation(28 days)
- Chage in length of Critical Care stay(28 days)
- Time from first dose to conversion to normal or mild pneumonia(28 days)
- Average change in quick sepsis-related organ failure assessment score (qSOFA) score between day 1, 7, 14 and 28.(1, 7, 14 and 28 days)
- Antibiotic requirement(28 days)
- Incidence of serious adverse event(28 days)
- Number of deaths from any cause at 28 days(28 days)
- Lymphocyte count(28 days)
研究者
Néstor H García
Principal Investigator
National Council of Scientific and Technical Research, Argentina