Covid-19Phase 3NCT04554433
New Treatment for COVID-19 Using Ethanol Vapor Inhalation .
A Phase 3 study testing Ethanol with Asprin in people with Covid-19 and Drug Effect, run by Mansoura University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Covid-19, Drug Effect
- What is being tested?
- Ethanol with Asprin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Show all 11Show fewer
- 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 )
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
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 .
Read the 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 .
- Conditions
- Covid-19, Drug Effect
- Being tested
- Ethanol with Asprin
- Keywords
- COVID-19, Clinical trial, Ethyl alcohol vapor inhalation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanol with AsprinDrug
Also called Controlled ethanol vapor inhalation combined with oral 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 .
- 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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 ..
Decrease mortality rate of mechanically ventilated patients with COVID-19 . Protection of health care workers . Negative PCR test .
Measured: Negative PCR test within 10 days from starting the protocol .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * (A) group: will receive the new protocol . * (B) group: Will receive the standard protocol .
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554433
- Sponsor's protocol ID
- 20.08.79
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disinfection of SARS-COV-2 ( COVID-19 ) in Human Respiratory Tract by Controlled Ethanol Vapor Inhalation Combined With Oral Asprin .
- ClinicalTrials.gov ID
- NCT04554433
- Acronym / sponsor ID
- 20.08.79
- Conditions
- Covid-19, Drug Effect
- Keywords
- COVID-19, Clinical trial, Ethyl alcohol vapor inhalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * (A) group: will receive the new protocol . * (B) group: Will receive the standard protocol .
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Ethanol with AsprinA ) 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 . |
| 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 . |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age from 20 - 60
- Confirmed COVID-19 positive with PCR test .
- Admitted to Mansoura university quarantine hospital ..
- Fever ≥ 38
- Respiratory rate ≥ 20
Key exclusion criteria (7 listed)
- Absence of any item from inclusion criteria
- Pregnancy .
- Signs of dehydration , Sepsis or shortness of breathing.
- Asthmatic patients .
- COPD .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanol with AsprinAlso: Controlled ethanol vapor inhalation combined with oral 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 . | Drug | Intervention |
Primary outcome
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 .
1 secondary outcome
Improvement of general condition of mechanically ventilated patients confirmed COVID-19 positive ..
Time frame: Negative PCR test within 10 days from starting the protocol .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethanol with Asprin in people with Covid-19 and Drug Effect, run by Mansoura University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ragab (+201099323347, Dr.ezz2712@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disinfection of COVID-19 in human respiratory tract . (time frame: Negative PCR test within 7 days from starting the protocol .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.