Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- rate of tracheal intubation
研究概览
简要总结
Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either palliative or curative ones.
One of the most important clinical problems in Covid-19 patients is lung involvement, which may causes significant sequels; leading to a main part of morbidity and/or mortality.
Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing the alveolar surface tension and by exerting immunomodulatory effects.
In a previous study by the same team, favorable effects were seen in intubated patients; however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant in the pre-intubation stages of the disease.
详细描述
Exogenous surfactant in neonates with clinical pulmonary distress syndrome has demonstrated pulmonary improvement; the latter being one of the most important applications of exogenous surfactant. In adults with underlying lung disease, especially Adult Respiratory Distress Syndrome (ARDS), there are controversial findings regarding the efficacy of surfactant.
However, in a previous study, it was shown that surfactant in COVID-19 patients with pulmonary intubation improved pulmonary function and gas exchange and also, reduced patient mortality.
However, none of the other repurposed drugs in COVID-19 have yet been able to prove significant effects in the treatment of patients; based on a recent study on more than 11000 COVID-19 patients (i.e. the SOLIDARITY study).
Due to the significant worldwide challnege with COVID-19, many efforts have been made in this regard, but the definitive cure has not yet been obtained, and therefore, efforts are being made to find an effective method to treat the disease and improve patients' symptoms; parallel to the efforts to increase the vaccination coverage.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor would be blind regarding the study groups
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •definitive proof of COVID-19 infection by polymerase chain reaction (PCR) within 48 hours of hospital admission
- •COVID-19 related Moderate ARDS following Berlin criteria definition with PaO2/FiO2 < 200 requiring what condition?
- •Signed and dated informed consent form (ICF) by the subject or caregivers
排除标准
- •known or high suspicion of pre-existing heart failure, unstable angina
- •presence of severe shock with hemodynamic instability despite escalating vasopressors
- •Severe, underlying pulmonary infection or severe pulmonary disease except for COVID-19 (COPD, pulmonary fibrosis, lung cancer, bacterial pneumonia, etc.)
- •Diagnosis of pulmonary hemorrhage
- •Pregnancy or lactation
- •Other significant cause than ARDS to the respiratory failure
- •Age less than 18
- •Age more than 80
- •Need for ECMO (extracorporeal membrane oxygenation) during the study
- •Anticipated transfer to another hospital within 72 hours
- •Known hypersensitivity to exogenous surfactant
- •Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes
研究组 & 干预措施
Nebulized Surfactant
The patients in this group will receive exogenous surfactant using nebulizer mask as soon as they are admitted in the hospital (ward or emergency department) with a diagnosis of COVID-19; in addition they will receive standard care based on the national guidelines
干预措施: exogenous surfactant (Drug)
结局指标
主要结局
rate of tracheal intubation
时间窗: through study completion, an average of 1 year
the frequency of patients who will be intubated due to deteriorated pulmonary function
rate of ICU admission
时间窗: through study completion, an average of 1 year
the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function
lowest oxygen saturation
时间窗: through study completion, an average of 1 year
lowest number reading in the pulse oxymetry in one of the fingers or toes
次要结局
- 30 days mortality(the first 30 days after hospital admission)
- 90 days mortality(the first 90 days after hospital admission)
研究者
Ali Dabbagh
Clinical Professor
Shahid Beheshti University of Medical Sciences