Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 主要终点
- Disinfection of COVID-19 in human respiratory tract .
研究概览
简要总结
Since ARDS is a major complication of COVID - 19 with subsequent formation of non-cardiogenic pulmonary edema , worsening the oxygenation of the patients and foamy and even bloody sputum formation, so the idea is to use alcohol inhalation as it reduce surface tension on the alveoli and markedly decrease sputum formation with improvement on oxygenation beside its cytolethal effect on virus lipid bilayer.
A lot of researches and publications proved the role of alcohol inhalation in treatment of pulmonary edema. Alcohol inhalation may has inflammatory effect and dangerous effect on patients but this can be controlled by the actual concentration used and the way we use it according to general condition of the patient and with the help of anti - inflammatory action of Asprin .
详细描述
Corona viruses can cause diseases in both animals and humans. Many of them typically infect upper respiratory tract with minor symptoms. However, three corona viruses can infect lower respiratory tract and cause fatal pneumonia; which are severe acute respiratory syndrome corona virus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and ( SARS-CoV-2). SARS-CoV-2 shares 78% similarity of genetic material with SARS-CoV.
Pathophysiology of both viruses are closely similar, with destructive inflammatory response resulting in airway damage. That's why, disease severity in patients depends, not only on the viral infection, but also on the host response.
In many cases, this will resolve the infection. However, in other cases, immune response dysfunctions and causes severe lung and systemic pathology ending to ARDS and respiratory failure .
Treatment according to this protocol will be focused on using Asprin to decrease inflammatory reaction weather from the virus or after using alcohol.
Alcohol will be used by different methods and concentration in order to decrease surface tension on alveoli , decreasing foamy sputum secretion , increasing vascular permeability and improving oxygenation .
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 - 60
- •Confirmed COVID-19 positive with PCR test .
- •Admitted to Mansoura university quarantine hospital ..
- •Fever ≥ 38
- •Respiratory rate ≥ 20
- •Myalgia , Arthralgia and Sore throat .
- •Radiological findings consisting with COVID-19 .
- •Welling to participate and able to give fully informed consent. Specific inclusion criteria according to the concentration and method :-
- •Inhalation of Alcohol vapor driven by Oxygen Respiratory distress ( Dyspnea - Orthopnea ) Spo2 : 65 - 85 ABG : Respiratory Alkalosis due to dyspnea and tachypnea PaO2 / FIO2 ratio > 300 mmHg under the condition in the hospital room (Moderate illness).
- •Inhalation of Alcohol vapor driven by oxygen in case of ARDS. Respiratory failure . CT : lobar collapse and nodules Non cardiogenic pulmonary edema excluded by ECHO or signs of overload . PaO2 / FIO2 ratio 101 - 300 mmHg on CPAP or Vent . ( Mild to moderate ARDS)
- •Ethyl Alcohol infusion into the airway PaO2 / FIO2 ratio ≤ 100 mmHg ( Sever ARDS )
排除标准
- •Absence of any item from inclusion criteria
- •Pregnancy .
- •Signs of dehydration , Sepsis or shortness of breathing.
- •Asthmatic patients .
- •Smokers ≥ 10 years .
- •Hypersensitivity to Alcohol
研究组 & 干预措施
Intervention
A ) Treatment group will receive a combination of Asprin in anti - inflammatory dose and controlled ethanol vapor inhalation in concentraions and technique according to their medical condition .
干预措施: Ethanol with Asprin (Drug)
结局指标
主要结局
Disinfection of COVID-19 in human respiratory tract .
时间窗: Negative PCR test within 7 days from starting the protocol .
Destruction of COVID-19 in human respiratory tract and treatment of the patients with COVID 19 and Negative PCR test .
次要结局
- Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..(Negative PCR test within 10 days from starting the protocol .)
研究者
Ragab
Resident of anesthesia and surgical ICU
Mansoura University