search
Back to results

New Treatment for COVID-19 Using Ethanol Vapor Inhalation .

Primary Purpose

Covid-19, Drug Effect

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ethanol with Asprin
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring COVID-19, Clinical trial, Ethyl alcohol vapor inhalation

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 )

Exclusion Criteria:

  • Absence of any item from inclusion criteria
  • Pregnancy .
  • Signs of dehydration , Sepsis or shortness of breathing.
  • Asthmatic patients .
  • COPD .
  • Smokers ≥ 10 years .
  • Hypersensitivity to Alcohol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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 .

    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 .

    Outcomes

    Primary Outcome Measures

    Disinfection of COVID-19 in human respiratory tract .
    Destruction of COVID-19 in human respiratory tract and treatment of the patients with COVID 19 and Negative PCR test .

    Secondary Outcome Measures

    Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..
    Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .

    Full Information

    First Posted
    September 17, 2020
    Last Updated
    October 27, 2020
    Sponsor
    Mansoura University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04554433
    Brief Title
    New Treatment for COVID-19 Using Ethanol Vapor Inhalation .
    Official Title
    Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    June 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 .
    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 . Inhaling alcohol vapor through nostrils . Inhalation of Alcohol vapor driven by Oxygen . Inhalation of Alcohol vapor driven by oxygen in case of ARDS. 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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Covid-19, Drug Effect
    Keywords
    COVID-19, Clinical trial, Ethyl alcohol vapor inhalation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    (A) group: will receive the new protocol . (B) group: Will receive the standard protocol .
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    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 .
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    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 .
    Intervention Type
    Drug
    Intervention Name(s)
    Ethanol with Asprin
    Other Intervention Name(s)
    Controlled ethanol vapor inhalation combined with oral Asprin .
    Intervention Description
    Group ( A ) which will receive the new protocol will be categorized into sub-groups according to the medical conditions , inclusion criteria , investigations and symptoms . Inhaling alcohol vapor through nostrils . Inhalation of Alcohol vapor driven by Oxygen . Inhalation of Alcohol vapor driven by oxygen in case of ARDS. 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 .
    Primary Outcome Measure Information:
    Title
    Disinfection of COVID-19 in human respiratory tract .
    Description
    Destruction of COVID-19 in human respiratory tract and treatment of the patients with COVID 19 and Negative PCR test .
    Time Frame
    Negative PCR test within 7 days from starting the protocol .
    Secondary Outcome Measure Information:
    Title
    Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..
    Description
    Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .
    Time Frame
    Negative PCR test within 10 days from starting the protocol .

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 ) Exclusion Criteria: Absence of any item from inclusion criteria Pregnancy . Signs of dehydration , Sepsis or shortness of breathing. Asthmatic patients . COPD . Smokers ≥ 10 years . Hypersensitivity to Alcohol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ragab
    Phone
    +201099323347
    Email
    Dr.ezz2712@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    New Treatment for COVID-19 Using Ethanol Vapor Inhalation .

    We'll reach out to this number within 24 hrs