Ivermectine effect in treatment of patients with COVID-19 disease (2024)

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Protocol summary

Study aim: 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 ivermectincurrent helminthic diseaseSevere 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 diseaseAdvanced renal failure with GFR<30Advanced liver failureAdvanced malignancySevere 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
See Also
Coronavirus : attention aux fausses informations sur la Covid-19 circulant sur les réseaux sociaux
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.
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