Protocol summary
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Study aim
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Evaluating the efficacy and safety of Ivermectin in the treatment of COVID-19 patients: A double-blind randomized controlled trial, phase II
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Design
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Randomize double blind clinical trial, with control group, with a sample size of 60 people, with parallel groups, Phase 2 of Clinical trial
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Settings and conduct
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The place of the study is Razi hospital and Sina hospital, Ahvaz university of medical science, simple sampling of patients with random allocation , double blind clinical trial, used drug and placebo, supervisor and participants are blind
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age ≥18 years, Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19, Hospitalized, Satisfaction to participate in the study, Acceptance of non-participation in another study before the 28th day of the study. Exclusion criteria: Patients with a history of allergic reaction to Ivermectin Renal dysfunction Liver dysfunction Pregnancy or deciding to get pregnant or breastfeeding
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Intervention groups
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Intervention group: Receive medication. One ivermectin 14 mg tablet every 12 hours for 3 days. Control group: placebo received a pill quite similar to Ivermectin every 12 hours for 3 days.
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Main outcome variables
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virus polymerase reaction chain, Number of hospitalization days, hospitfever, dyspnea, , cough, chest CT scan, cell blood count, C-reactive protein
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200404046937N4
Registration date:
2020-08-06, 1399/05/16
Registration timing:
registered_while_recruiting
Last update:
2021-06-11, 1400/03/21
Update count:
1
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Registration date
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2020-08-06, 1399/05/16
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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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2020-07-30, 1399/05/09
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Expected recruitment end date
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2020-08-30, 1399/06/09
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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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Evaluating the efficacy and safety of Ivermectin in the treatment of COVID-19 patients: A double-blind randomized controlled trial, phase II
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Public title
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Evaluating the effect of Ivermectin on covid 19 patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ≥18 years
Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19
Hospitalized
Satisfaction to participate in the study
Acceptance of non-participation in another study before the 28th day of the study
Exclusion criteria:
Patients with a history of allergic reaction to Ivermectin
Renal dysfunction
Liver dysfunction
Pregnancy or deciding to get pregnant or breastfeeding
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Age
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From 18 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical software, make a random sequence is by using statistical software allocation concealment is by assigning unique codes
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group.The drug in both groups is exactly the same in pill form and is in exactly the same packages. The packages are distinguished only by mentioning the number and the list of numbers will be at the disposal of the statistical consultant and then the data will be analyzed.
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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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2020-06-26, 1399/04/06
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Ethics committee reference number
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IR.AJUMS.REC.1399.322
Health conditions studied
1
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Description of health condition studied
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COVID 19
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ICD-10 code
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U07.1
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ICD-10 code description
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Corona virus infection, unspecified
Primary outcomes
1
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Description
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Viral diagnostic test
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Timepoint
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The first day of the study
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Method of measurement
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Polymerase chain reaction
2
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Description
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Duration of hospitalization
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Timepoint
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Time of dyscharge
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Method of measurement
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Patient file
Secondary outcomes
1
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Description
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Fever
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Timepoint
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Daily
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Method of measurement
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Thermometer
2
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Description
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Respiratory rate
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Timepoint
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Daily
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Method of measurement
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Patient file
3
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Description
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Dyspnea
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
4
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Description
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Cough
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Timepoint
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Daily
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Method of measurement
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Patients interview and patient file
5
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Description
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Cell blood count
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Lab test
6
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Description
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C_reactive protein
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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Lab test
7
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Description
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CT scan
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Timepoint
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The first day of the study and the end of the study
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Method of measurement
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CT scan set
Intervention groups
1
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Description
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Intervention group: Patients in the itervetion group will receive the drug of this study after treatment with routine medications of the disease, which is 14 mg ivermectin tablet, so that the patient will receive one ivermectin tablet every 12 hours for 3 days and then at the time of discharge, Patient symptoms and laboratory data and CT scans will be reviewed.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in the control group will receive placebo after treatment with routine medications, which is quite similar to ivermectin, in that the patient will receive one placebo pill every 12 hours for 3 days, and then at the time of discharge, Patient symptoms and laboratory data and CT scans will be reviewed.d.
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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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Ahvaz 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available