New Treatment for COVID-19 Using Ethanol Vapor Inhalation .

• ClinicalTrials.gov Identifier: NCT04554433
• Recruitment Status: Unknown
• First Posted: September 18, 2020
• Last Update Posted: October 28, 2020
• Sponsor: Mansoura University
• Information provided by (Responsible Party): Ragab, Mansoura University

Tracking Information

• First Submitted Date: September 17, 2020
• First Posted Date: September 18, 2020
• Last Update Posted Date: October 28, 2020
• Estimated Study Start Date: December 1, 2020
• Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 .

Current Secondary Outcome Measures (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 (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 .

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 .

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: Interventional
• Study Phase: Phase 3

Study Design

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

• Covid-19
• Drug Effect

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 17, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2022
• Estimated Primary Completion Date: October 1, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04554433
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Ragab, Mansoura University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mansoura University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mansoura University
• Verification Date: October 2020