New Treatment for COVID-19 Using Ethanol Vapor Inhalation .
NCT ID: NCT04554433
Last Updated: 2020-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2020-12-01
2022-06-01
Brief Summary
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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
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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 .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* (B) group: Will receive the standard protocol .
TREATMENT
NONE
Study Groups
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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 .
Ethanol with Asprin
Group ( A ) which will receive the new protocol will be categorized into sub-groups according to the medical conditions , inclusion criteria , investigations and symptoms .
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 . Investigations will be made before starting the protocol and follow up data will be collected every day .
Follow up test will be done according to the schedule . PCR test will be done according to the duration of each technique to evaluate the final results .
Control
B ) Control group : will receive the standard protocol . Data collection will include : sociodemographic data , clinical history , results of follow up ( daily or according to clinical situation ) Follow up : to record any side effects of drugs , and swab will be taken for PCR .
No interventions assigned to this group
Interventions
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Ethanol with Asprin
Group ( A ) which will receive the new protocol will be categorized into sub-groups according to the medical conditions , inclusion criteria , investigations and symptoms .
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 . Investigations will be made before starting the protocol and follow up data will be collected every day .
Follow up test will be done according to the schedule . PCR test will be done according to the duration of each technique to evaluate the final results .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 .
* 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 )
* Pregnancy .
* Signs of dehydration , Sepsis or shortness of breathing.
* Asthmatic patients .
* COPD .
* Smokers ≥ 10 years .
* Hypersensitivity to Alcohol
20 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Ragab
Resident of anesthesia and surgical ICU
Central Contacts
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Other Identifiers
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20.08.79
Identifier Type: -
Identifier Source: org_study_id