Evaluation of the effectiveness of inhaled ethanol therapy in the control of Covid-19 disease
Design
Phase 3 clinical trial with a control group, parallel and single-blind type, in which the patient remains unaware of the name of the intervention drug.
Random sampling on 86 patients.
Settings and conduct
This study was performed at Issa Bin Maryam Hospital in, Iran on patients who are temporarily hospitalized to receive remedicivir and dexamethasone or are hospitalized for several days in other wards. For patients in the ethanol group the oxygen flow meter or the nebulizer is poured with ethanol 35% .
Participants/Inclusion and exclusion criteria
Eligibility criteria
Positive RT-PCR test
Less than seven days from onset of symptoms
Age 15-69 years;
Non-Eligibility criteria
Pregnancy
History of asthma
Alcoholism
Epilepsy
Contraindications to ethanol
Disagreement of the treating physician
Intervention groups
In both groups, standard treatments are given according to the usual procedure. In the intervention group the inhaled ethanol is also added. Inhalation of 10 ml of 70% ethanol with 10 ml of distilled water in an oxygen flow meter with a flow of 2-3 liters per minute, every six hours for 15 minutes for up to five days will be our intervention. If the patient does not accept this method, the same amount of ethanol and distilled water is poured into the cold nebulizer and it is prescribed. In the control group, only 20 ml distilled water is poured into an oxygen flow meter instead of ethanol.
Main outcome variables
Symptoms, SPO2, WBC, CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210725051981N1
Registration date:2021-10-19, 1400/07/27
Registration timing:prospective
Last update:2021-10-19, 1400/07/27
Update count:0
Registration date
2021-10-19, 1400/07/27
Registrant information
Name
Ali Amoushahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3667 6152
Email address
aliamoushahi@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-26, 1400/08/04
Expected recruitment end date
2021-11-25, 1400/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Ethanol inhalation on early stage of COVID-19 (a clinical trial study)
Public title
Inhalation Ethanol therapy in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive RT-PCR test of SARS-COV2
Less than 7 days of starting of signs or symptoms of COVID-19
Age 15-69 yr
Exclusion criteria:
Pregnancy
History of Asthma
History of Alcohol dependency
History of Seizure
Contraindication of Ethanol addministration
Disagreement of patient physician
Age
From 15 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization tool: Random number table
Even and zero digits are assigned to the ethanol treatment group and odd numbers to the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The blinding of the participant is done by not telling him the name of the drug under study. Analysts and staff collecting the data are given questionnaires in two groups named A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of School of Medicine - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.MUI.MED.REC.1400.506
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Requires non-temporary hospitalization
Timepoint
Daily until 5 daus
Method of measurement
Counting the days
2
Description
Needing to ICU admission
Timepoint
Days 7, 14, 21
Method of measurement
Evaluate medical file records
3
Description
Mortality Rate
Timepoint
Days 7, 14, 21, 28
Method of measurement
Evaluate medical file records
4
Description
Respiratory status of patients
Timepoint
ِDays from 1 to 5
Method of measurement
SPO2
5
Description
Inflammatory condition
Timepoint
Days 1-5-14
Method of measurement
WBC counting -CRP titration
6
Description
Clinical status
Timepoint
Days 1-5-14
Method of measurement
Score from the table of clinical signs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, in addition to the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, nebulizing ethanol is also added in this way. Four times a day, each time 10 ml of ethanol 70% of Sepahan bio-product CO. is poured in oxygen flowmeter or in the tank of the nebulizer device. After that, we add 10 ml of distilled water to it and encourage the patient to inhale it from mouth and nose. This technique must repeat for five days.
Category
Treatment - Drugs
2
Description
Control group: In this group, the current treatment of Covid-19, which is remdesivir and methylprednisolone or dexamethasone, is continued, and 20 ml of distilled water as placebo is poured into an oxygen flow meter or nebulizer, and the patient is encouraged to inhale it.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isa Ben Maryam Hospital
Full name of responsible person
Ali Amoushahi
Street address
Shams Abadi St.
City
Isfahan
Province
Isfehan
Postal code
8134735945
Phone
+98 31 3235 1541
Email
aliamoushah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghju Javanmard
Street address
Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Moazam
Position
Social medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Shams Abadi
City
Isfahan
Province
Isfehan
Postal code
8134735945
Phone
+98 31 3235 1541
Fax
+98 21 8978 4962
Email
el_moazam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Amoushahi
Position
Specialist Physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ayneh Khane Avn.
City
Isfahan
Province
Isfehan
Postal code
8164644370
Phone
+98 31 3667 6152
Email
aliamoushah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Amoushahi
Position
Specialist physician
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasargad Complex, Ayneh Khane Avn.
City
Isfahan
Province
Isfehan
Postal code
8164644370
Phone
+98 31 3667 6152
Email
aliamoushah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is shareable.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It is permissible to use this data to find patients who respond better to this treatment.
From where data/document is obtainable
Contact Ali Amoshahi by phone (00989131158298) or email (aliamoushah@gmail.com).
What processes are involved for a request to access data/document
The request will be answered in a week in consultation with other partners in the project.