Protocol summary
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Study aim
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Dose finding of Ivermectin in control and treatment of COVID-19 patients and suggesting it as an antiviral drug against COVID-19
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Design
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clinical trial with control group, with parallel groups (5 groups in sum), double blinded, randomized with Randomizer software, with 100 participants.
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Settings and conduct
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This randomized double blinded multi center clinical trial will be implemented in Qazvin Bu Ali and Velayat hospitals and Khuzestan Razi, Sina and Taleghani hospitals.
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Participants/Inclusion and exclusion criteria
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1. Patients who test positive for COVID-19 by a commercially available Rapid Antigen Test (RAT) of the nasopharynx.
2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken.
3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment:
o Cough
o Sore throat
o Headache
o Nasal congestion
o Feeling feverish
o Body aches
o Fatigue
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Intervention groups
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Control group 1: Standard regimen based on Iran health ministry, Control group 2: Standard regimen based on Iran health ministry plus Placebo, Intervention group 1: Standard regimen based on Iran health ministry plus low dose Ivermectin (200 mcg/kg , PO, Once), Intervention group 2: Standard regimen based on Iran health ministry plus high dose Ivermectin(400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5), Intervention group 3: High dose Ivermectin (400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5)
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Main outcome variables
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chest CT scan, hospitalization time, CBC and CRP
General information
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Reason for update
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adding a new intervention group, changing Ivermectin dosages
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200408046987N1
Registration date:
2020-04-27, 1399/02/08
Registration timing:
prospective
Last update:
2020-07-21, 1399/04/31
Update count:
1
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Registration date
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2020-04-27, 1399/02/08
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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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2020-05-04, 1399/02/15
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Expected recruitment end date
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2020-06-04, 1399/03/15
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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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Dose-Finding study of Ivermectin treatment on patients infected with Covid-19:A clinical trial
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Public title
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Dose-Finding Study of Ivermectin in the Treatment of 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 who test positive for COVID-19 by a commercially available Test
Patients ≥ 20 but < 65 years of age with a temperature (oral) of 38°C
patients 65 - 80 years of age with a temperature (oral) of 37.8°C
Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment: Cough Sore throat Headache Nasal congestion Feeling feverisho Body aches and pains Fatigue (tiredness)
Exclusion criteria:
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Age
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From 20 years old to 80 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
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
125
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, simple randomization method will be used. A randomized list will be generated by online randomization site. Patients will be allocated to case or control group according to the generated list.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants will receive drug or placebo after signing the consort letter. Practitioner and consequence analyzer will not know about the treatment. Data analyzer will know the groups number only.
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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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2020-04-21, 1399/02/02
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Ethics committee reference number
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IR.QUMS.REC.1399.017
2
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Ethics committee
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Approval date
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2020-06-09, 1399/03/20
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Ethics committee reference number
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22144/20/د
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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COVID-19
Primary outcomes
1
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Description
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chest image(CT scan)
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Timepoint
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at hospital clearance
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Method of measurement
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Patient's profile(CT scan image)
2
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Description
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hospitalization time
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Timepoint
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end of intervention
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Method of measurement
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Hospitalization time
3
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Description
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CBC and CRP
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Timepoint
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Before intervention, 7 days after intervention
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Method of measurement
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Sampling and lab test
Intervention groups
1
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Description
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Control group: Standard regimen based on Iran health ministry
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Standard regimen based on Iran health ministry plus low dose Ivermectin(200 mcg/kg , PO, Once)
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Category
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Treatment - Drugs
3
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Description
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Intervention group: Standard regimen based on Iran health ministry plus high dose Ivermectin(200 mcg/kg , PO, interval days:1,2,5)
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Category
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Treatment - Drugs
4
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Description
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Control group: Standard regimen based on Iran health ministry plus Placebo,Once in first day. placebo is a simple tablet containing only fillers without any active ingredient and is made by Alborz Darou company.
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Category
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Treatment - Drugs
5
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Description
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Intervention group: 400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5
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Category
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Treatment - Drugs
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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Chistasazan Notash Fartak Company Limited.
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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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Private
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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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Other
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