Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 7:18 AM
Study NCT ID:
NCT04554433
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Treatment for COVID-19 Using Ethanol Vapor Inhalation .
Sponsor:
Mansoura University
Organization:
Study Overview
Official Title:
Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 .
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 .
Detailed Description:
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 .
Also the investigator will use it as a prophylaxis for health care workers to disinfect the virus as soon as possible while it is present in nasal mucosa and upper airway.
Patients will be classified according to inclusion and exclusion criteria and will be divided into groups and they will receive the protocol as it is designed in concentrations and techniques suitable for their medical condition .
In this trial , The investigator will use 4 method to administrate Ethyl Alcohol to the patient by different concentrations .
1. Inhaling alcohol vapor through nostrils .
2. Inhalation of Alcohol vapor driven by Oxygen .
3. Inhalation of Alcohol vapor driven by oxygen in case of ARDS.
4. Ethyl Alcohol infusion into the airway . In each method , the patient will be prepared for one day before starting the protocol by prophylactic antibiotic , anti - inflammatory , mucolytic and bronchodilators .
Investigations will be made before starting for follow up of the results .
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 .
Also the investigator will use it as a prophylaxis for health care workers to disinfect the virus as soon as possible while it is present in nasal mucosa and upper airway.
Patients will be classified according to inclusion and exclusion criteria and will be divided into groups and they will receive the protocol as it is designed in concentrations and techniques suitable for their medical condition .
In this trial , The investigator will use 4 method to administrate Ethyl Alcohol to the patient by different concentrations .
1. Inhaling alcohol vapor through nostrils .
2. Inhalation of Alcohol vapor driven by Oxygen .
3. Inhalation of Alcohol vapor driven by oxygen in case of ARDS.
4. Ethyl Alcohol infusion into the airway . In each method , the patient will be prepared for one day before starting the protocol by prophylactic antibiotic , anti - inflammatory , mucolytic and bronchodilators .
Investigations will be made before starting for follow up of the results .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: