Determining the effect of ivermectin on PCR test, clinical improvement, percentage and duration of hospitalization in outpatients with COVID-19
Design
Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 500 patients. Patients are divided into two groups by a simple randomization method with a table of random numbers. The control group will receive standard and placebo treatment and the intervention group will receive Ivermectin for three days in addition to the standard treatment.
Settings and conduct
COVID-19 positive rapid test patients referred to family physician and infectious disease specialist are divided into two groups of intervention and control. The present study is double-blind so that patients and physicians will be unaware of how the intervention and control groups are assigned.
Participants/Inclusion and exclusion criteria
Patients with COVID-19 positive rapid test weighing more than 15 kg are included in the study
Intervention groups
The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Europhartech France for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg
Main outcome variables
The primary outpoints are clinical improvement and negative PCR result after 5 days. Clinical improvement is defined as reduction in persistent cough (more than one hour of excessive coughing, or 3 periods of coughing in 24 hours that disrupts daily life and ability to work) and tachypnea and O2 saturation above 94%.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111224008507N4
Registration date:2021-01-31, 1399/11/12
Registration timing:prospective
Last update:2021-01-31, 1399/11/12
Update count:1
Registration date
2021-01-31, 1399/11/12
Registrant information
Name
Mohammadsadegh Rezai
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1325 7230
Email address
rezai@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of outpatients with COVID-19 in 2021
Public title
Evaluation of the effect of Ivermectin in treatment of outpatients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive coronavirus rapid test
No need for hospitalization
Weight >15 kg
No treatment with antiviral drugs before and during the study
Informed consent for inclusion
Exclusion criteria:
Underlying liver and kidney disease
Patients with acquired immunodeficiency
Consumption of warfarin and ACEI family drugs (captopril, enalapril, etc.)
Pregnancy and lactation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
500
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to two groups of intervention and control with 250 members using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the samples, none of the participant will be aware of randomization and allocation to groups. Physicians are given a table of pre-coded numbered numbers and patients are entered into the study in order of table numbers. Therefore, the present study is double-blind. Ivermectin and placebo tablets are the same shape, color and size and are delivered to the patient/parents in a package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی مازندران
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Approval date
2020-12-30, 1399/10/10
Ethics committee reference number
IR.MAZUMS.REC.1399.869
Health conditions studied
1
Description of health condition studied
COVID-19 infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Clinical improvement
Timepoint
Daily until improvement
Method of measurement
Clinical improvement is defined as reduction in persistent cough (more than one hour of excessive coughing, or 3 periods of coughing in 24 hours that disrupts daily life and ability to work) and tachypnea and O2 saturation above 94%.
2
Description
Negative PCR result
Timepoint
6 days after intervention
Method of measurement
RT-PCR
Secondary outcomes
1
Description
The main complaints recovery time
Timepoint
Daily until symptoms resolve
Method of measurement
Checklist containing patient complaints
2
Description
Need to be hospitalized
Timepoint
Daily until hospitalization or improvement
Method of measurement
Percentage of hospitalization and the interval from the beginning of the intervention to hospitalization
3
Description
Mortality
Timepoint
Daily
Method of measurement
Record in checklist
4
Description
Drug side effect
Timepoint
Daily
Method of measurement
Wheezing, itching, skin rash, edema, and hypotension are assessed daily
Intervention groups
1
Description
Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Europhartech France for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg
Category
Treatment - Drugs
2
Description
Control group: In the control group, placebo tablets made by the Department of Pharmacology of Mazandaran University of Medical Sciences with the same shape, color and weight based dose of ivermectin will be used for three days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of family physicians and infectious disease specialists and pediatric infectious diseases sub
Full name of responsible person
Dr Mohammad Sadegh Rezai
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Vice chancellor for Research, Moallem square, Sari
City
Sari
Province
Mazandaran
Postal code
4712855689
Phone
+98 11 3334 2334
Email
msaidi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Sadegh Rezai
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bouali Hospital, Pasdaran boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Mohammadsadegh Rezai
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Infectious diseases
Street address
Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
drmsrezaii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinzadeh
Position
Officer
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bouali Hospital, Pasdaran Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 2334
Email
fatima.hzade@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
Not applicable
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
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data is accessible
When the data will become available and for how long
Starting in January 2021
To whom data/document is available
Everybody
Under which criteria data/document could be used
Systematic review articles
From where data/document is obtainable
Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com
What processes are involved for a request to access data/document
After contact, information is sent within a few days