Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04554433 |
| Other study ID # |
20.08.79 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
October 2020 |
| Source |
Mansoura University |
| Contact |
Ragab |
| Phone |
+201099323347 |
| Email |
Dr.ezz2712[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 .
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 .
