New Treatment for COVID-19 Using Ethanol Vapor Inhalation .

NCT04554433 | Unknown Phase 3 DMC

• 1 other identifier: 20.08.79
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Covid-19; Drug Effect

Keywords

COVID-19; Clinical trial; Ethyl alcohol vapor inhalation

Outcome Measures

Primary Outcomes (1)

• 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 .

  Negative PCR test within 7 days from starting the protocol .

Secondary Outcomes (1)

• Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..

  Negative PCR test within 10 days from starting the protocol .

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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 .

Drug: Ethanol with Asprin

Control

NO INTERVENTION

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 .

Interventions

Ethanol with Asprin DRUG

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 .

Also known as: Controlled ethanol vapor inhalation combined with oral Asprin .

Intervention

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .
• 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 )

You may not qualify if:

• Pregnancy .
• Signs of dehydration , Sepsis or shortness of breathing.
• Asthmatic patients .
• COPD .
• Smokers ≥ 10 years .
• Hypersensitivity to Alcohol

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

COVID-19

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Ragab

CONTACT

+201099323347; Dr.ezz2712@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anesthesia and surgical ICU

Model Details: * (A) group: will receive the new protocol . * (B) group: Will receive the standard protocol .

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 18, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: June 1, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-10