History
# Registration date Revision Id
2 2020-05-25, 1399/03/05 144019
1 2020-04-27, 1399/02/08 131517
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  • Protocol summary

    clinical trial with control group, with parallel groups (4 groups in sum), double blinded, randomized with Randomizer software, with 100 participants.
    clinical trial with control group, with parallel groups (5 groups in sum), double blinded, randomized with Randomizer software, with 100 participants.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی (مجموعا 4 گروه)، دو سویه کور ، تصادفی شده با نرم افزار Randomizer با حجم نمونه 100 نفر
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی (مجموعا 5 گروه)، دو سویه کور ، تصادفی شده با نرم افزار Randomizer با حجم نمونه 125 نفر
    This randomized double blinded clinical trial will be implemented in Qazvin Velayat hospital.
    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.
    این مطالعه به صورت کارآزمایی بالینی تصادفی به صورت دو سو کور می باشد که در بیمارستان ولایت قزوین انجام خواهد شد.
    این مطالعه به صورت کارآزمایی بالینی تصادفی به صورت دو سو کور و چند مرکزی می باشد که در بیمارستانهای بوعلی و ولایت قزوین و بیمارستان های سینا، رازی و طالقانی استان خوزستان انجام خواهد شد.
    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)
    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)
    گروه کنترل1: رژیم درمانی استاندارد وزارت بهداشت ایران، گروه کنترل2: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه دارونما، گروه مداخله1: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز پایین(200 میکروگرم بر کیلوگرم، خوراکی، یک مرتبه)، گروه مداخله2: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز بالا(200 میکروگرم بر کیلوگرم، با اینتروال روزهای اول و دوم و پنجم)
    گروه کنترل1: رژیم درمانی استاندارد وزارت بهداشت ایران، گروه کنترل2: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه دارونما، گروه مداخله1: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز پایین(200 میکروگرم بر کیلوگرم، خوراکی، یک مرتبه)، گروه مداخله2: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز بالا(400 میکروگرم بر کیلوگرم در روز اول، 200 میکروگرم بر کیلوگرم در روزهای دوم و پنجم) گروه مداخله3: آیورمکتین با دوز بالا(400 میکروگرم بر کیلوگرم در روز اول، 200 میکروگرم بر کیلوگرم در روزهای دوم و پنجم)
  • General information

    100
    125
    empty
    adding a new intervention group, changing Ivermectin dosages
    empty
    اضافه کردن یک گروه مداخله جدید، تغییر دوز تجویزی ایورمکتین
  • Ethics committees

    #1
    empty
    2020-06-09, 1399/03/20
    empty
    22144/20/د
  • Intervention groups

    #1
    گروه مداخله: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز پایین(200 میکروگرم بر کیلوگرم، خوراکی، یک مرتبه)
    گروه مداخله: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز پایین(400 میکروگرم بر کیلوگرم، خوراکی، یک مرتبه)
    #2
    گروه مداخله: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز بالا(200 میکروگرم بر کیلوگرم با اینتروال روز اول و دوم و پنجم)
    گروه مداخله: رژیم درمانی استاندارد وزارت بهداشت ایران به اضافه آیورمکتین با دوز بالا(400 میکروگرم بر کیلوگرم در روز اول، 200 میکروگرم بر کیلوگرم در روزهای دوم و پنجم)
    #3
    empty
    Treatment - Drugs
    empty
    Intervention group: 400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5
    empty
    گروه مداخله: آیورمکتین 400 میکروگرم بر کیلوگرم در روز اول، 200 میکروگرم بر کیلوگرم در روزهای دوم و پنجم
  • Recruitment centers

    #1
    Name of recruitment center - English: Velayat Hospital
    Name of recruitment center - Persian: بیمارستان ولایت
    Full name of responsible person - English: Dr. Aliakbar Karami
    Full name of responsible person - Persian: دکتر علی اکبر کرمی
    Street address - English: velayat hospital, taavon square, 22 bahman boulevard, Minoodar town
    Street address - Persian: مینودر، بلوار 22 بهمن ، میدان تعاون، مرکز آموزشی و درمانی ولایت
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3471991984
    Phone: +98 28 3379 0620
    Fax: +98 28 3379 0611
    Email: Ali32024@yahoo.com
    Web page address:
    Name of recruitment center - English: Velayat Hospital
    Name of recruitment center - Persian: بیمارستان ولایت
    Full name of responsible person - English: Dr. Aliakbar Karami, Dr Elham Zsabganeh
    Full name of responsible person - Persian: دکتر علی اکبر کرمی، دکتر الهام زنگنه
    Street address - English: velayat hospital, taavon square, 22 bahman boulevard, Minoodar town
    Street address - Persian: مینودر، بلوار 22 بهمن ، میدان تعاون، مرکز آموزشی و درمانی ولایت
    City - English: Qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3471991984
    Phone: +98 28 3379 0620
    Fax: +98 28 3379 0611
    Email: Ali32024@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Sina Hospital
    Name of recruitment center - Persian: بیمارستان سینا
    Full name of responsible person - English: Dr mohamad jafar yadyad, Dr mehran Varnasseri
    Full name of responsible person - Persian: دکتر محمدجعفر یدید، دکتر مهران ورناصری
    Street address - English: Shahed1 avenue, Imam Ali square, Ayatollah behbahani boulevard
    Street address - Persian: بلوار آیت الله بهبهانی، میدان امام علی(ع)، خیابان شاهد1
    City - English: ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 82213410
    Phone: +98 61 3555 0591
    Fax:
    Email: 2.myadyad@yahoo.com
    Web page address:
    #3
    Name of recruitment center - English: Razi Hospital
    Name of recruitment center - Persian: بیمارستان رازی
    Full name of responsible person - English: Dr mehrdad dargahi, Dr Amir Hooshang Bavarsad
    Full name of responsible person - Persian: دکتر مهرداد درگاهی، دکتر امیرهوشنگ باورصاد
    Street address - English: Felestin Boulevard, Amaniyeh
    Street address - Persian: امانیه، بلوار فلسطین
    City - English: Ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 82213410
    Phone: +98 61 3333 5935
    Fax:
    Email: dr.mehrdad.dargahi@gmail.com
    Web page address:
    #4
    Name of recruitment center - English: Taleghani Hospital
    Name of recruitment center - Persian: بیمارستان طالقانی
    Full name of responsible person - English: Dr Ramin Jamshidian, Dr Fatemeh Amini
    Full name of responsible person - Persian: دکتر رامین جمشیدیان، دکتر فاطمه امینی
    Street address - English: Mosta'an Boulevard, Amanieh
    Street address - Persian: امانیه، بلوار مستعان
    City - English: Ahwaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6193874473
    Phone: +98 61 3554 0255
    Fax:
    Email: Jamshidian.ramin@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Chistasazan notash fartak
    Name of organization / entity - Persian: شرکت چیستاسازان نوتاش فرتاک
    Full name of responsible person - English: dr. morteza shakhs niaee
    Full name of responsible person - Persian: دکتر مرتضی شخصی نیایی
    Street address - English: science and technology park
    Street address - Persian: پارک علم و فناوری قزوین
    City - English: qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3471991984
    Phone: +98 28 3336 7100
    Fax:
    Email: dr.niaee@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Chistasazan Notash Fartak Company Limited.
    Name of organization / entity - Persian: شرکت چیستاسازان نوتاش فرتاک
    Full name of responsible person - English: Dr morteza shakhs niaee
    Full name of responsible person - Persian: دکتر مرتضی شخصی نیایی
    Street address - English: science and technology park
    Street address - Persian: پارک علم و فناوری قزوین
    City - English: qazvin
    City - Persian: قزوین
    Province: Qazvin
    Country: Iran (Islamic Republic of)
    Postal code: 3471991984
    Phone: +98 28 3336 7100
    Fax:
    Email: dr.niaee@gmail.com
    Web page address:
    Chistasazan notash fartak
    Chistasazan Notash Fartak Company Limited.

Protocol summary

Study aim
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 (5 groups in sum), double blinded, randomized with Randomizer software, with 100 participants.
Settings and conduct
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.
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(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)
Main outcome variables
chest CT scan, hospitalization time, CBC and CRP

General information

Reason for update
adding a new intervention group, changing Ivermectin dosages
Acronym
IRCT registration information
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
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: 125
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

2

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
3419915315
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
22144/20/د

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

5

Description
Intervention group: 400 mcg/kg in day1 followed by 200 mcg/kg in day 2 and day 5
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Aliakbar Karami, Dr Elham Zsabganeh
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

3

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr mohamad jafar yadyad, Dr mehran Varnasseri
Street address
Shahed1 avenue, Imam Ali square, Ayatollah behbahani boulevard
City
ahwaz
Province
Khouzestan
Postal code
82213410
Phone
+98 61 3555 0591
Email
2.myadyad@yahoo.com

4

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr mehrdad dargahi, Dr Amir Hooshang Bavarsad
Street address
Felestin Boulevard, Amaniyeh
City
Ahwaz
Province
Khouzestan
Postal code
82213410
Phone
+98 61 3333 5935
Email
dr.mehrdad.dargahi@gmail.com

5

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Ramin Jamshidian, Dr Fatemeh Amini
Street address
Mosta'an Boulevard, Amanieh
City
Ahwaz
Province
Khouzestan
Postal code
6193874473
Phone
+98 61 3554 0255
Email
Jamshidian.ramin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chistasazan Notash Fartak Company Limited.
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 Company Limited.
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
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