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Protocol summary
100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control. Patients and doctors will be blinded.
100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control.
100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control. Patients and doctors will be blinded.
100 بیمار مبتلا به COVID-19 بستری در بیمارستان فیروزگر به صورت تصادفی در دو گروه مداخله و کنترل تقسیم می شوند. کورسازی در پزشک، پرستار و بیمار صورت می خواهد گرفت.
100 بیمار مبتلا به COVID-19 بستری در بیمارستان فیروزگر به صورت تصادفی در دو گروه مداخله و کنترل تقسیم می شوند.
100 بیمار مبتلا به COVID-19 بستری در بیمارستان فیروزگر به صورت تصادفی در دو گروه مداخله و کنترل تقسیم می شوند. کورسازی در پزشک، پرستار و بیمار صورت می خواهد گرفت.
Patients in the control group will be given a standard treatment regimen including Kaletra (Lopinavir-Ritonavir) and Hydroxychloroquine according to guidlines. Patients in the intervention group will be given oral Hydroxychloroquine with Arbidol orally at a dose of 50 mg 4 times daily for 5 to 10 days.
Patients in the control group will be given a standard treatment regimen including Kaletra (Lopinavir-Ritonavir) and Hydroxychloroquine according to guidlines. Patients in the intervention group will be given oral Hydroxychloroquine with Arbidol orally at a dose of 50 mg 3 times daily for 5 to 10 days.
Patients in the control group will be given a standard treatment regimen including Kaletra (Lopinavir-Ritonavir) and Hydroxychloroquine according to guidlines. Patients in the intervention group will be given oral Hydroxychloroquine with Arbidol orally at a dose of 50 mg 43 times daily for 5 to 10 days.
به بیماران گروه کنترل، رژیم درمانی استاندارد شامل کلترا (Lopinavir-Ritonavir) همراه هیدروکسی کلروکین، طبق دستورالعمل ها
داده خواهد شد. به بیماران گروه مداخله، هیدروکسی کلروکین همراه آربیدول به صورت خوراکی با دوز 50 میلی گرم، 4 بار در روز برای5 تا 10روز به بیماران داده خواهد شد.
به بیماران گروه کنترل، رژیم درمانی استاندارد شامل کلترا (Lopinavir-Ritonavir) همراه هیدروکسی کلروکین، طبق دستورالعمل ها
داده خواهد شد. به بیماران گروه مداخله، هیدروکسی کلروکین همراه آربیدول به صورت خوراکی با دوز 50 میلی گرم، 3 بار در روز برای5 تا 10روز به بیماران داده خواهد شد.
به بیماران گروه کنترل، رژیم درمانی استاندارد شامل کلترا (Lopinavir-Ritonavir) همراه هیدروکسی کلروکین، طبق دستورالعمل ها داده خواهد شد. به بیماران گروه مداخله، هیدروکسی کلروکین همراه آربیدول به صورت خوراکی با دوز 50 میلی گرم، 43 بار در روز برای5 تا 10روز به بیماران داده خواهد شد.
General information
empty
Due to the implementation requirements, the update has been made in accordance with the existing conditions.
Due to the implementation requirements, the update has been made in accordance with the existing conditions.
empty
با توجه متقضیات اجرا بروز رسانی متناسب با شرایط موجود صورت گرفته است.
با توجه متقضیات اجرا بروز رسانی متناسب با شرایط موجود صورت گرفته است.
Primary outcomes
#1
Improvement of patients fever
Measurement of patients fever
ImprovementMeasurement of patients fever
بهبود تب بیماران
اندازه گیری تب بیماران
بهبوداندازه گیری تب بیماران
#2
Improvement of complete blood count test
Measurement of complete blood count test
ImprovementMeasurement of complete blood count test
بهبود آزمایش شمارش کامل سلول های خون
اندازه گیری آزمایش شمارش کامل سلول های خون
بهبوداندازه گیری آزمایش شمارش کامل سلول های خون
#3
Improvement of C-reactive protein test
Determination of C-reactive protein test
ImprovementDetermination of C-reactive protein test
بهبود آزمایش پروتئین واکنشی C
تعیین آزمایش پروتئین واکنشی C
بهبودتعیین آزمایش پروتئین واکنشی C
#4
Improvement of chest X-Ray symptoms
chest CT Scan view symptoms
Improvement of chest X-RayCT Scan view symptoms
بهبود علائم عکس قفسه سینه
مشاهده علائم تصویر سی تی اسکن قفسه سینه
بهبودمشاهده علائم عکستصویر سی تی اسکن قفسه سینه
Examination of patient's chest x-ray at the beginning of the study and 7 days after starting treatment
Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment
Examination of patient'sPatient's chest x-rayCT scan check at the beginning of the study and 730 days after starting treatment
بررسی عکس رادیوگرافی قفسه سینه بیمار در ابتدای مطالعه و 7 روز پس از شروع درمان
بررسی عکس سی تی اسکن قفسه سینه بیمار در ابتدای مطالعه و سی روز پس از شروع درمان
بررسی عکس رادیوگرافیسی تی اسکن قفسه سینه بیمار در ابتدای مطالعه و 7سی روز پس از شروع درمان
Taking a chest x-ray
Taking a chest CT scan
Taking a chest x-rayCT scan
انجام عکس رادیوگرافی قفسه سینه
انجام عکس سی تی اسکن قفسه سینه
انجام عکس رادیوگرافیسی تی اسکن قفسه سینه
#5
Improvement of blood oxygen saturation and no adjuvant oxygen therapy
Measurement of blood oxygen saturation and no adjuvant oxygen therapy
ImprovementMeasurement of blood oxygen saturation and no adjuvant oxygen therapy
بهبود اشباع اکسیژن خون و عدم نیاز به درمان کمکی اکسیژن
اندازه گیری اشباع اکسیژن خون و عدم نیاز به درمان کمکی اکسیژن
بهبوداندازه گیری اشباع اکسیژن خون و عدم نیاز به درمان کمکی اکسیژن
Secondary outcomes
#1
Improvement of erythrocyte sedimentation rate test
Measurement of erythrocyte sedimentation rate test
ImprovementMeasurement of erythrocyte sedimentation rate test
بهبود آزمایش سرعت رسوب گلبول های قرمز
اندازه گیری آزمایش سرعت رسوب گلبول های قرمز
بهبوداندازه گیری آزمایش سرعت رسوب گلبول های قرمز
اندازه گیری سرعت رسوب گلبول های قرمز در ابتدای مطالعه و 7 روز پس از شروع درمان
اندازه گیری سرعت رسوب گلبول های قرمز در ابتدای مطالعه و 7 روز پس از شروع درمان
اندازه گیری سرعت رسوب گلبول های قرمز در ابتدای مطالعه و 7 روز پس از شروع درمان
Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine 400 mg single dose and Arbidol orally at a dose of 50 mg 4 times a day for 5 to 10 days.
Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days.
Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg single dose/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 50200 mg 43 times a day for 5 to 10 days.
گروه مداخله: به 50 بیمار مبتلا به کووید-19 رژیم درمانی شامل دو قرص هیدروکسی کلروکین سولفات خوراکی 200 میلی گرم به صورت تک دوز همراه قرص آربیدول خوراکی با دوز 50 میلی گرم، 4 بار در روز برای 5 تا 10روز دریافت خواهند کرد.
گروه مداخله: به 50 بیمار مبتلا به کووید-19 رژیم درمانی شامل رژیم استاندارد هیدروکسی کلروکین سولفات (روز اول 400 میلی گرم دو بار در روز و از روز دوم 200 میلی گرم 2 بار در روز) به همراه قرص آربیدول خوراکی با دوز 200 میلی گرم، 3 بار در روز برای 5 تا 10روز دریافت خواهند کرد.
گروه مداخله: به 50 بیمار مبتلا به کووید-19 رژیم درمانی شامل دو قرصرژیم استاندارد هیدروکسی کلروکین سولفات خوراکی(روز اول 400 میلی گرم دو بار در روز و از روز دوم 200 میلی گرم 2 بار در روز) به صورت تک دوز همراه قرص آربیدول خوراکی با دوز 50200 میلی گرم، 43 بار در روز برای 5 تا 10روز دریافت خواهند کرد.
#2
Control group: Sixty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and two Hydroxychloroquine sulfate 200 mg tablets as a single dose for 5 to 10 days.
Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days.
Control group: SixtyFifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and two Hydroxychloroquine sulfate 200 mg tablets as a (single dose 400 mg/ BD for first day) for 5 to 10 days.
گروه کنترل: به 60 بیمار کووید-19 گروه کنترل، رژیم درمانی 2 قرص کلترا 200/50 میلی گرم هر 12 ساعت و دو قرص هیدروکسی کلروکین سولفات 200 میلی گرم به صورت تک دوز به مدت 5 تا 10 روز داده خواهد شد.
گروه کنترل: به 50 بیمار کووید-19 گروه کنترل، رژیم درمانی استاندارد کلترا 200/50 میلی گرم هر 12 ساعت ورژیم هیدروکسی کلروکین سولفات (یک دوز 400 میلی گرم 2 بار در روز) به مدت 5 تا 10 روز داده خواهد شد.
گروه کنترل: به 6050 بیمار کووید-19 گروه کنترل، رژیم درمانی 2 قرصاستاندارد کلترا 200/50 میلی گرم هر 12 ساعت و دو قرصورژیم هیدروکسی کلروکین سولفات 200(یک دوز 400 میلی گرم به صورت تک دوز2 بار در روز) به مدت 5 تا 10 روز داده خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان فیروزگر
Name of recruitment center - Persian: Firoozgar hospital
Full name of responsible person - English: Dr. Mitra ranjbar
Full name of responsible person - Persian: دکتر میترا رنجبر
Street address - English: Firoozgar hospital., Beh Afarin Ave., Karimkhan Ave., Valiasr Sq
Street address - Persian: میدان ولیعصر ( عج )، خیابان کریم خان زند، خیابان به آفرین، بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۵۹۳۷۴۷۸۱۱
Phone: +98 21 8214 1600
Fax:
Email: h_firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: Firoozgar hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr. Mitra ranjbar
Full name of responsible person - Persian: دکتر میترا رنجبر
Street address - English: Firoozgar hospital., Beh Afarin Ave., Karimkhan Ave., Valiasr Sq
Street address - Persian: میدان ولیعصر ( عج )، خیابان کریم خان زند، خیابان به آفرین، بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1593747811
Phone: +98 21 8214 1600
Fax:
Email: h_firoozgar@yahoo.com
Web page address:
Name of recruitment center - English: بیمارستان فیروزگرFiroozgar hospital Name of recruitment center - Persian: Firoozgar hospitalبیمارستان فیروزگر Full name of responsible person - English: Dr. Mitra ranjbar Full name of responsible person - Persian: دکتر میترا رنجبر Street address - English: Firoozgar hospital., Beh Afarin Ave., Karimkhan Ave., Valiasr Sq Street address - Persian: میدان ولیعصر ( عج )، خیابان کریم خان زند، خیابان به آفرین، بیمارستان فیروزگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۵۹۳۷۴۷۸۱۱1593747811 Phone: +98 21 8214 1600 Fax: Email: h_firoozgar@yahoo.com Web page address:
Sponsors / Funding sources
#1
100
80
10080
#2
contact.organization_id:
Name of organization / entity - English: Presidential Transformation and Development Cooperation Center
Name of organization / entity - Persian: مرکز همکاری های تحول و پیشرفت ریاست جمهوری
Full name of responsible person - English: Doctor sirous vatankhah
Full name of responsible person - Persian: دكتر سيروس وطن خواه
Street address - English: No 8, East Avesta str, Sheikh Baha'i Square
Street address - Persian: ميدان شيخ بهايي، خيابان اوستاي شرقي، پلاك ٨
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1995859611
Phone: +98 21 6100 6100
Fax:
Email: Info@cpdi.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Presidential Transformation and Development Cooperation Center Name of organization / entity - Persian: مرکز همکاری های تحول و پیشرفت ریاست جمهوری Full name of responsible person - English: Doctor sirous vatankhah Full name of responsible person - Persian: دكتر سيروس وطن خواه Street address - English: No 8, East Avesta str, Sheikh Baha'i Square Street address - Persian: ميدان شيخ بهايي، خيابان اوستاي شرقي، پلاك ٨ City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1995859611 Phone: +98 21 6100 6100 Fax: Email: Info@cpdi.ir Web page address:
empty
Yes
1
empty
20
20
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
empty
Presidential Transformation and Development Cooperation Center
Presidential Transformation and Development Cooperation Center
empty
مرکز همکاری های تحول و پیشرفت ریاست جمهوری
مرکز همکاری های تحول و پیشرفت ریاست جمهوری
Protocol summary
Study aim
1- Determining the effect of Arbidol in the treatment of patients with Coronavirus hospitalized in Firoozgar hospital.
2- Determining the effect of therapy according to guidelines in treatment of patients with Coronavirus.
3- Comparison of effect of treatment of patients with Coronavirus in Firoozgar hospital between control and intervention groups.
Design
Two arm parallel group, phase 3 trial, with total sample size of 100, simple randomization using random blocks
Settings and conduct
100 COVID-19 patients, hospitalization in Firoozgar hospital are randomly divided into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age equal or greater than 18 years; Signing a consent form; Diagnosis of COVID-19 by chest CT-scan or RT-PCR test.
Exclusion criteria: People with a history of allergies to this drug and / or a history of severe allergies; ََPatients who used Arbidol (Tablets, capsules, granules) before hospitalization; Women who are breastfeeding or pregnant, Respiratory failure, renal or liver failure, Anemia or thrombocytopenia, Coagulation disorders, patients who received immunosuppressive drugs during 3 months ago, congenital heart disease,, arrhythmia
Intervention groups
Patients in the control group will be given a standard treatment regimen including Kaletra (Lopinavir-Ritonavir) and Hydroxychloroquine according to guidlines. Patients in the intervention group will be given oral Hydroxychloroquine with Arbidol orally at a dose of 50 mg 3 times daily for 5 to 10 days.
Main outcome variables
Antipyretic rate; Improvement of complete blood count ESR and CRP tests; Virus negative conversion rate; Improvement of blood oxygen saturation and no adjuvant oxygen therapy; Improvement of chest X-Ray symptoms
General information
Reason for update
Due to the implementation requirements, the update has been made in accordance with the existing conditions.
Acronym
IRCT registration information
IRCT registration number:IRCT20180725040596N2
Registration date:2020-04-18, 1399/01/30
Registration timing:prospective
Last update:2020-06-12, 1399/03/23
Update count:2
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Nasir Dehghan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 5162
Email address
dehghan.n@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19
Public title
Effect of Arbidol in treatment of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age equal or greater than 18 years
Signing informed consent
Diagnosis of COVID-19 by chest CT-scan or RT-PCR test
Exclusion criteria:
Respiratory failure
People with a history of allergies to this drug and or a history of severe allergies
Patients who used Arbidol (Tablets, capsules, granules) before hospitalization
Women who are breastfeeding or pregnant
Renal or liver function failure
Anemia or thrombocytopenia
Patient who received immunosuppressive drug during 3 months ago
Congenital heart failure
History of arrhythmia
coagulation disorders
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Method: Simple randomization.
Unit: Individual.
Tools: Random blocks
How to build: Using 4 times Blocks (AABB, ABAB, ....) with random selection of block and reading from right to left
Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Ethics Committee of Iran University of Medical Sciences, Hemmat expressways, Iran University of Medical sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-04-14, 1399/01/26
Ethics committee reference number
IR.IUMS.REC.1399.090
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Measurement of patients fever
Timepoint
Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment
Method of measurement
Thermometer
2
Description
Measurement of complete blood count test
Timepoint
Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
3
Description
Determination of C-reactive protein test
Timepoint
Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
4
Description
chest CT Scan view symptoms
Timepoint
Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment
Method of measurement
Taking a chest CT scan
5
Description
Measurement of blood oxygen saturation and no adjuvant oxygen therapy
Timepoint
Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Measurement of erythrocyte sedimentation rate test
Timepoint
Measurement of erythrocyte sedimentation rate at the beginning of the study and 7 days after starting treatment
Method of measurement
Blood test
2
Description
Observing virological results
Timepoint
Measurement of patient's sputum viral load at the beginning of the study and 7 days after starting treatment
Method of measurement
Real-time polymerase chain reaction test
Intervention groups
1
Description
Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days.
Category
Treatment - Drugs
2
Description
Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days.
Iran University of Medical Sciences., Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 2225
Email
mnojomi@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Marzieh Nojomi
Position
Professor of Community Medicine
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Fax
+98 21 8860 2217
Email
mnojomi@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after patients have become unrecognizable.
When the data will become available and for how long
The information access will begin immediately after the results are shared.
To whom data/document is available
University researchers and industry professionals will be able to access the data.
Under which criteria data/document could be used
Individuals with official letters from research centers, research institutes, research institutes affiliated with the Ministry of Health, as well as scientific research institutes will be able to view without interference.
From where data/document is obtainable
Individuals should refer to the Prevention Medicine and Public Health Research Center of Iran University of Medical Sciences located in Tehran, Hemmat Highway, next to Milad Tower, School of Medicine, third floor to Ms. Neda Soleiman Vandi.
Website address: www.pmph.iums.ac.ir
Email: pmph@iums.ac.ir
Phone number: 02186703350
Postal Code: 1449614535
Mailbox: 354-14665
What processes are involved for a request to access data/document
By sending an e-mail or sending a letter to the esteemed head of the Prevention Medicine and Public Health Research Center Iran University of Medical Sciences and presenting the reasons for their request so that they will receive the data in less than a month after examining their reasons and during the relevant legal procedure.