The effect of Ivermectin on COVID19 virus, studied in vitro and reported by Australian investigators. In this study we intend to verify the efficacy of Ivermectin on the effect of this drug on the on the course of this disease and possible prevention from ICU admission, intubation, and mortality as well as some laboratory hallmarks in this disease.
Design
After randomization to two groups of 25 individuals the subjects in treatment group will receive three doses of oral ivermectin 200 micrograms/Kg once every other day for 3 doses plus the usual national protocol of treatment for COVID-19 disease while the control group receive only the national treatment protocol. Clinical trial with be one-way blind, phase 3 trial. Clinical findings and physiological parameters of respiration and treatment outcome as well as the changes in laboratory findings will be recorded. The results of the study will be analyzed using SPSS software.
Settings and conduct
In this study, 25 patients with COVID 19 being admitted to ImamReza Hospital who do not meet the exclusion criteria and after matching the similar control group of patients with this disease, in addition to the usual care, will receive three doses of oral ivermectin 200 micrograms / kg once every other day for 3 doses.
Participants/Inclusion and exclusion criteria
50 patients with COVID 19 disease with no exclusion criteria
Exclusion criteria:
history of allergy to ivermectin
current helminthic disease
Severe CHF, arrhythmia, renal or hepatic failure, end stage malignancy or any other disease on discretion of the physician before randomization and recruitment.
Intervention groups
ivermectin
Main outcome variables
ICU admission, intubation and mechanical ventilation, and mortality as well as the changes in LDH, CRP, and NLR as a marker of disease activity and predictors of the outcome in COVID-19 disease.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200818048444N3
Registration date:2021-06-20, 1400/03/30
Registration timing:retrospective
Last update:2021-06-20, 1400/03/30
Update count:0
Registration date
2021-06-20, 1400/03/30
Registrant information
Name
Khalil Ansarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8093
Email address
dr.ansarin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-02, 1399/09/12
Expected recruitment end date
2021-01-31, 1399/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ivermectine effect in treatment of patients with COVID-19 disease
Public title
Ivermectine effect in treatment and prophylaxis of patients and exposed idividuals with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of COVID-19 disease
Exclusion criteria:
History of allergy to ivermectin, and evidence for current helminthic disease
Advanced renal failure with GFR<30
Advanced liver failure
Advanced malignancy
Severe heart failure or active cardiac arrhythmia
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the eligibility criteria and obtaining informed consent from patients, they will be assigned into the study groups using the Balanced Block Randomization method generated by the designer of the study. The size of the blocks and random sequence generation process will not be clarified for the principal investigator and other researchers so that the allocation concealment will be fully established. In addition, randomization efficacy will be tested at the end of the study and those confounding variables with imbalanced distribution across the study groups will be adjusted through the multivariable models.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Committee on Research Ethics (Studies in Human Subjects)
Street address
No .2, Tabriz University of Medical Science. Golgasht st., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-07-20, 1399/04/30
Ethics committee reference number
IR.TBZMED.REC.1399.375
Health conditions studied
1
Description of health condition studied
Covid-19 Disease
ICD-10 code
U07.1
ICD-10 code description
Covid-19 Disease
Primary outcomes
1
Description
Patient mortality
Timepoint
Within 28 days after the onset of the disease
Method of measurement
Physician report
2
Description
Transfer to ICU
Timepoint
Within 28 days after the onset of the disease
Method of measurement
Physician report
3
Description
Intubation or mechanical ventilation
Timepoint
Within 28 days after the onset of the disease
Method of measurement
Physician report
Secondary outcomes
1
Description
Improve clinical symptoms
Timepoint
Start treatment up to 28 days
Method of measurement
Physician report
2
Description
CRP value
Timepoint
Start treatment up to 28 days
Method of measurement
Measurements in serum
3
Description
LDH value
Timepoint
Start treatment up to 28 days
Method of measurement
Measurements in serum
4
Description
NLR value
Timepoint
Start treatment up to 28 days
Method of measurement
Measurement with CBCD
Intervention groups
1
Description
Intervention group: 3 doses of oral ivermectin 200 μg / kg once daily for 3 doses
Category
Treatment - Drugs
2
Description
Control group: The patients in the control group will receive the standard treatment recommended by ministry of health for this disease
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Khalil Ansarin
Street address
Imam Reza Hospital, Golgasht str.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ministry of Health
Full name of responsible person
Dr. Harirchi, Iraj
Street address
Ghods Town, Iran Sima St., between Flamek and Zarafshan, Headquarters of the Ministry of Health, Treatment and Medical Education
City
Tehran
Province
East Azarbaijan
Postal code
Phone
+98 21 8836 3560
Email
mardomi@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khalil Ansarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St.
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3337 8093
Email
dr.ansarin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Professor Khalil Ansarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3337 8093
Fax
+98 41 3337 8093
Email
dr.ansarin@gmail.com
Web page address
https://isid.research.ac.ir/Khalil_Ansarin
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khalil Ansarin
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St
City
Tabriz
Province
East Azarbaijan
Postal code
5142954481
Phone
+98 41 3337 8093
Email
dr.ansarin@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
No - There is not 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
No - There is not 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 can potentially be shared after unidentified individuals.
When the data will become available and for how long
Spring 1400
To whom data/document is available
Data is allowed for all researchers after submitting an access request and confirming it
Under which criteria data/document could be used
In order to use the data, researchers must first identify and send the required items and data upon request, after which the data will be delivered.
From where data/document is obtainable
By email dr.ansarin@gmail.com or postal code: 5142954481
What processes are involved for a request to access data/document
The researcher must state his request in a letter. After agreeing to his request, the data will be emailed to him in Excel or Spss.