Protocol summary
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Study aim
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Determining the effect of ivermectin on PCR test, clinical improvement, percentage and duration of hospitalization in outpatients with COVID-19
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Design
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Clinical trial with control group, parallel groups, double-blind, randomized, phase 3 on 1000 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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Patients with COVID-19 positive rapid test or RT-PCR age >5 years and weight >15 kg are included in the study
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Intervention groups
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The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 6 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru Co of Iran 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
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Main outcome variables
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The primary outpoints are clinical improvement and negative PCR result after 6 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
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Reason for update
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Increase in sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20111224008507N4
Registration date:
2021-01-31, 1399/11/12
Registration timing:
prospective
Last update:
2021-03-06, 1399/12/16
Update count:
1
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Registration date
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2021-01-31, 1399/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-19, 1399/12/01
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Expected recruitment end date
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2021-08-22, 1400/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of outpatients with COVID-19 in 2021
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Public title
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Evaluation of the effect of Ivermectin in treatment of outpatients with COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with positive coronavirus rapid test or RT-PCR positive
No need for hospitalization
Weight >15 kg
Age >5 years
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
Pregnancy and lactation
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Age
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From 5 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
1000
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be randomly assigned to two groups of intervention and control with 500 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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-12-30, 1399/10/10
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Ethics committee reference number
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IR.MAZUMS.REC.1399.869
Health conditions studied
1
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Description of health condition studied
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COVID-19 infection
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ICD-10 code
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B34.2
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ICD-10 code description
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Coronavirus infection, unspecified
Primary outcomes
1
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Description
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Clinical improvement
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Timepoint
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Daily until improvement
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Method of measurement
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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
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Description
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Negative PCR result
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Timepoint
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6 days after intervention
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Method of measurement
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RT-PCR
Secondary outcomes
1
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Description
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The main complaints recovery time
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Timepoint
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Daily until symptoms resolve
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Method of measurement
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Checklist containing patient complaints
2
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Description
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Need to be hospitalized
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Timepoint
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Daily until hospitalization or improvement
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Method of measurement
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Percentage of hospitalization and the interval from the beginning of the intervention to hospitalization
3
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Description
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Mortality
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Timepoint
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Daily
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Method of measurement
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Record in checklist
4
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Description
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Drug side effect
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Timepoint
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Daily
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Method of measurement
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Wheezing, itching, skin rash, edema, and hypotension are assessed daily
Intervention groups
1
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Description
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Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 6 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru Co, Iran 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
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group, placebo tablets made by Alborz Daru company of Iran with the same shape, color and weight based dose of ivermectin will be used for three days.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Part of the data is accessible
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When the data will become available and for how long
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Starting in January 2022
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To whom data/document is available
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Everybody
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Under which criteria data/document could be used
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Systematic review articles
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From where data/document is obtainable
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Contact Dr. Mohammad Sadegh Rezai. E-mail: drmsrezaii@yahoo.com
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What processes are involved for a request to access data/document
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After contact, information is sent within a few days
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Comments
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