Dose finding of Ivermectin in control and treatment of COVID-19 patients and suggesting it as an antiviral drug against COVID-19
Design
clinical trial with control group, with parallel groups (4 groups in sum), double blinded, randomized with Randomizer software, with 100 participants.
Settings and conduct
This randomized double blinded clinical trial will be implemented in Qazvin Velayat hospital.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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(200 mcg/kg , PO, Intervals days: 1,2,5)
Main outcome variables
chest CT scan, hospitalization time, CBC and CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046987N1
Registration date:2020-04-27, 1399/02/08
Registration timing:prospective
Last update:2020-04-27, 1399/02/08
Update count:1
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
Nematollah Gheibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 8212
Email address
ngheibi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dose-Finding study of Ivermectin treatment on patients infected with Covid-19:A clinical trial
Public title
Dose-Finding Study of Ivermectin in the Treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
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:
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonr Blvd. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
----------
Approval date
2020-04-21, 1399/02/02
Ethics committee reference number
IR.QUMS.REC.1399.017
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
chest image(CT scan)
Timepoint
at hospital clearance
Method of measurement
Patient's profile(CT scan image)
2
Description
hospitalization time
Timepoint
end of intervention
Method of measurement
Hospitalization time
3
Description
CBC and CRP
Timepoint
Before intervention, 7 days after intervention
Method of measurement
Sampling and lab test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Standard regimen based on Iran health ministry
Category
Treatment - Drugs
2
Description
Intervention group: Standard regimen based on Iran health ministry plus low dose Ivermectin(200 mcg/kg , PO, Once)
Category
Treatment - Drugs
3
Description
Intervention group: Standard regimen based on Iran health ministry plus high dose Ivermectin(200 mcg/kg , PO, interval days:1,2,5)
Category
Treatment - Drugs
4
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Aliakbar Karami
Street address
velayat hospital, taavon square, 22 bahman boulevard, Minoodar town
City
Qazvin
Province
Qazvin
Postal code
3471991984
Phone
+98 28 3379 0620
Fax
+98 28 3379 0611
Email
Ali32024@yahoo.com
2
Recruitment center
Name of recruitment center
Bo ALI hospital
Full name of responsible person
Dr Abbas Allami
Street address
Bo Ali Street
City
Qazvin
Province
Qazvin
Postal code
-----------
Phone
+98 28 3333 6001
Email
allami9@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chistasazan notash fartak
Full name of responsible person
dr. morteza shakhs niaee
Street address
science and technology park
City
qazvin
Province
Qazvin
Postal code
3471991984
Phone
+98 28 3336 7100
Email
dr.niaee@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chistasazan notash fartak
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nematollah Gheibi
Position
Professor of University
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Shaid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3741999184
Phone
+98 28 3332 8212
Fax
+98 28 3332 8213
Email
ngheibi@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nematollah Gheibi
Position
Professor of University
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Shaid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3741999184
Phone
+98 28 3332 8212
Fax
+98 28 3332 8213
Email
ngheibi@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nematollah Gheibi
Position
Professor of University
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Shaid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3741999184
Phone
+98 28 3332 8212
Fax
+98 28 3332 8213
Email
ngheibi@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available