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New Treatment for COVID-19 Using Ethanol Vapor Inhalation .

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554433
Recruitment Status : Not yet recruiting
First Posted : September 18, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ragab, Mansoura University

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE September 18, 2020
Last Update Posted Date October 28, 2020
Estimated Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
Disinfection of COVID-19 in human respiratory tract . [ Time Frame: 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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2020)
Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive .. [ Time Frame: Negative PCR test within 10 days from starting the protocol . ]
Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Treatment for COVID-19 Using Ethanol Vapor Inhalation .
Official Title  ICMJE Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
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 .

  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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • (A) group: will receive the new protocol .
  • (B) group: Will receive the standard protocol .
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Drug Effect
Intervention  ICMJE Drug: 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 Name: Controlled ethanol vapor inhalation combined with oral Asprin .
Study Arms  ICMJE
  • Active Comparator: 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 .
    Intervention: Drug: Ethanol with Asprin
  • No Intervention: 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 .
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ragab +201099323347 Dr.ezz2712@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04554433
Other Study ID Numbers  ICMJE 20.08.79
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ragab, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP