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Protocol summary
A double-blind randomized clinical trial study with a control group with a parallel design; on 60 patients. Block randomization method was used for randomization.
A double-blind randomized adaptive clinical trial study with a control group with a parallel design; on 300 patients. Block randomization method will be used for randomization.
A double-blind randomized adaptive clinical trial study with a control group with a parallel design; on 60300 patients. Block randomization method waswill be used for randomization.
مطالعه کارازمایی بالینی دارای گروه کنترل با گروه موازی و دوسویه کور تصادفی شده بر روی 60 بیمار. روش تصادفی سازی بلوکی برای تصادفی سازی استفاده شد.
مطالعه کارازمایی بالینی تطبیقی دارای گروه کنترل با گروه موازی و دوسویه کور تصادفی شده بر روی 300 بیمار. روش تصادفی سازی بلوکی برای تصادفی سازی استفاده شد.
مطالعه کارازمایی بالینی تطبیقی دارای گروه کنترل با گروه موازی و دوسویه کور تصادفی شده بر روی 60300 بیمار. روش تصادفی سازی بلوکی برای تصادفی سازی استفاده شد.
Subject clinical status (10 point WHO clinical progression scale)
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days
Subject clinical status (10 point WHO clinicalDisease progression scale)defined as death or hospital admission or seeking emergency or urgent care within 15 days
وضعيت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهاني
پیشرفت بیماری برمبنای مرگ یا بستری یا نیز به مراقبت فوری
وضعيت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهانيپیشرفت بیماری برمبنای مرگ یا بستری یا نیز به مراقبت فوری
General information
Coronavirus disease
Coronavirus disease
60
300
60300
2022-03-11, 1400/12/20
2022-05-14, 1401/02/24
2022-0305-1114 00:00:00
I want to add actual recruitment date which is 2021-12-15
Increasing sample size and description of outcomes
I want to add actual recruitment date which is 2021-12-15Increasing sample size and description of outcomes
ميخواهم زمان واقعي نمونه گيري را وارد کنم که 24 آذرماه 1400 است.
افزايش حجم نمونه و توضيح پيامدها
ميخواهم زمان واقعيافزايش حجم نمونه گيري را وارد کنم که 24 آذرماه 1400 است.و توضيح پيامدها
Permuted Block Randomization was used for random allocation. The size of the blocks was randomly selected. There were 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations were considered for the intervention group and two allocations for the control group. Random Allocation Software was used for this purpose. The concealment was done using sequentially numbered, sealed envelopes.
Permuted Block Randomization will be used for random allocation. The size of the blocks will randomly selected. There are 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations are considered for the intervention group and two allocations for the control group. Random Allocation Software will be used for this purpose. The concealment will done using sequentially numbered, sealed envelopes.
Permuted Block Randomization waswill be used for random allocation. The size of the blocks waswill randomly selected. There wereare 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations wereare considered for the intervention group and two allocations for the control group. Random Allocation Software waswill be used for this purpose. The concealment waswill done using sequentially numbered, sealed envelopes.
جهت تخصیص تصادفی، از روش تصادفی سازی بلوکی (Permuted Block Randomization) استفاده شد. اندازه بلوک ها به صورت تصادفی انتخاب شدند. بلوک های تصادفی 4، تایی بود که در هر بلوک به تعداد مساوی از هر دو گروه مداخله و کنترل موجود است. در بلوک های 4 تایی دو تخصیص برای گروه مداخله و دو تخصیص برای گروه کنترل در نظر گرفته شد. برای این منظور از نرم افزار Random Allocation Software استفاده شد. پنهان سازی با استفاده از نامه های که به صورت متوالی شماره گذاری شده و مهر و موم شده بود انجام شد.
جهت تخصیص تصادفی، از روش تصادفی سازی بلوکی (Permuted Block Randomization) استفاده خواهد شد. اندازه بلوک ها به صورت تصادفی انتخاب ميشوند. بلوک های تصادفی 4، تایی بود که در هر بلوک به تعداد مساوی از هر دو گروه مداخله و کنترل موجود است. در بلوک های 4 تایی دو تخصیص برای گروه مداخله و دو تخصیص برای گروه کنترل در نظر گرفته شده است. برای این منظور از نرم افزار Random Allocation Software استفاده ميشود. پنهان سازی با استفاده از نامه های که به صورت متوالی شماره گذاری شده و مهر و موم شده بود انجام ميشود.
جهت تخصیص تصادفی، از روش تصادفی سازی بلوکی (Permuted Block Randomization) استفاده خواهد شد. اندازه بلوک ها به صورت تصادفی انتخاب شدندميشوند. بلوک های تصادفی 4، تایی بود که در هر بلوک به تعداد مساوی از هر دو گروه مداخله و کنترل موجود است. در بلوک های 4 تایی دو تخصیص برای گروه مداخله و دو تخصیص برای گروه کنترل در نظر گرفته شدشده است. برای این منظور از نرم افزار Random Allocation Software استفاده شدميشود. پنهان سازی با استفاده از نامه های که به صورت متوالی شماره گذاری شده و مهر و موم شده بود انجام شدميشود.
Ethics committees
#1
2021-11-29, 1400/09/08
2021-12-15, 1400/09/24
2021-1112-2915 00:00:00
Primary outcomes
#1
Subject clinical status (10 point WHO clinical progression scale)
Disease progression within 15 days after randomization, on the basis of 11 points WHO clinical progression scale.
Subject clinical status (10 pointDisease progression within 15 days after randomization, on the basis of 11 points WHO clinical progression scale).
وضعيت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهاني
پیشرفت بیماری بر مبنای مقياس پيشرفت باليني 11 امتيازي WHO طی ۱۵ روز از زمان ورود به مطالعه
وضعيتپیشرفت بیماری بر مبنای مقياس پيشرفت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهاني11 امتيازي WHO طی ۱۵ روز از زمان ورود به مطالعه
day 15
During 15 days from intervention
dayDuring 15 days from intervention
روز پانزدهم
در مدت 15 روز از زمان مداخله
در مدت 15 روز پانزدهماز زمان مداخله
WHO 10 point progresson scale
clinical and paraclinical data
WHO 10 point progresson scaleclinical and paraclinical data
سيستم امتيازدهي 10 مرحله اي سازمان بهداشت جهاني
داده های بالینی و پاراکلینیک
سيستم امتيازدهي 10 مرحله اي سازمان بهداشت جهانيداده های بالینی و پاراکلینیک
Secondary outcomes
#1
National early warning scale
Thromboembolic events
National early warning scaleThromboembolic events
امتياز هشدار زودرس ملي
حوادث ترومبو آمبولیک
امتياز هشدار زودرس مليحوادث ترومبو آمبولیک
Days: 3,5,8,11,13,15
within 30 days after intervention
Days: 3,5,8,11,13,15within 30 days after intervention
روزهاي 3-5-8-11-15
در مدت 30 روز از شروع مداخله
روزهاي 3-5-8-11-15در مدت 30 روز از شروع مداخله
pulse oximeter, thermometer, sphygmomanometer
clinical and paraclinical data
pulse oximeter, thermometer, sphygmomanometerclinical and paraclinical data
پالس اکسيمتر، ترمومتر، فشارسنج
یافته های بالینی و پارا کلینیک
پالس اکسيمتر، ترمومتر، فشارسنجیافته های بالینی و پارا کلینیک
#2
Subject clinical status (10 point WHO clinical progression scale)
hospital-free days
Subject clinical status (10 point WHO clinical progression scale)hospital-free days
وضعيت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهاني
روزهاي بدون بستري
وضعيت باليني بيمار بر مبناي امتياز 10 مرحله اي سازمان بهداشت جهانيروزهاي بدون بستري
Days: 3,5,8,11,13,15
within 30 days after intervention
Days: 3,5,8,11,13,15within 30 days after intervention
روزهاي 3-5-8-11-15
در مدت 30 روز از شروع مداخله
روزهاي 3-5-8-11-15در مدت 30 روز از شروع مداخله
WHO 10 point progresson scale
Observation
WHO 10 point progresson scaleObservation
سيستم امتيازدهي 10 مرحله اي سازمان بهداشت جهاني
مشاهده
سيستم امتيازدهي 10 مرحله اي سازمان بهداشت جهانيمشاهده
#3
empty
Death from any cause
Death from any cause
empty
مرگ به هر دليل
مرگ به هر دليل
empty
within 30 days after intervention
within 30 days after intervention
empty
در مدت 30 روز از شروع مداخله
در مدت 30 روز از شروع مداخله
empty
Patient's medical record
Patient's medical record
empty
پرونده پزشکی بیمار
پرونده پزشکی بیمار
Recruitment centers
#1
Name of recruitment center - English: Ilam Mostafa Khomaini hospital
Name of recruitment center - Persian: بيمارستان مصطفي خميني ايلام
Full name of responsible person - English: Shaahin Shahbazi
Full name of responsible person - Persian: شاهين شهبازي
Street address - English: Tapeh Khargooshan St
Street address - Persian: خيابان تپه خرگوشان
City - English: Ilam
City - Persian: ايلام
Province: Ilam
Country: Iran (Islamic Republic of)
Postal code: 1639393939
Phone: +98 84 3333 8228
Fax:
Email: mdkabe@gmail.com
Web page address:
Name of recruitment center - English: Ilam Mostafa Khomaini hospital
Name of recruitment center - Persian: بيمارستان مصطفي خميني ايلام
Full name of responsible person - English: Shaahin Shahbazi
Full name of responsible person - Persian: شاهين شهبازي
Street address - English: Tapeh Khargooshan St
Street address - Persian: خيابان تپه خرگوشان
City - English: Ilam
City - Persian: ايلام
Province: Ilam
Country: Iran (Islamic Republic of)
Postal code: 1639393939
Phone: +98 84 3333 8228
Fax:
Email: mdkabe@gmail.com
Web page address: http://mostafahospital.medilam.ac.ir/
Name of recruitment center - English: Ilam Mostafa Khomaini hospital Name of recruitment center - Persian: بيمارستان مصطفي خميني ايلام Full name of responsible person - English: Shaahin Shahbazi Full name of responsible person - Persian: شاهين شهبازي Street address - English: Tapeh Khargooshan St Street address - Persian: خيابان تپه خرگوشان City - English: Ilam City - Persian: ايلام Province: Ilam Country: Iran (Islamic Republic of) Postal code: 1639393939 Phone: +98 84 3333 8228 Fax: Email: mdkabe@gmail.com Web page address: http://mostafahospital.medilam.ac.ir/
#2
Name of recruitment center - English: Ilam emamkhomeiny hospital
Name of recruitment center - Persian: بیمارستان امام خمینی ایلام
Full name of responsible person - English: shaahin shahbazi
Full name of responsible person - Persian: شاهین شهبازی
Street address - English: خیابان حیدری بیمارستان امام خمینی
Street address - Persian: Heidari street , Emamkhomeini hospital
City - English: Ilam
City - Persian: ایلام
Province: Ilam
Country: Iran (Islamic Republic of)
Postal code: 6931975397
Phone: +98 84 3333 4500
Fax:
Email: mdkabe@gmail.com
Web page address: http://emamhospital.medilam.ac.ir
Name of recruitment center - English: Ilam emamkhomeiny hospital Name of recruitment center - Persian: بیمارستان امام خمینی ایلام Full name of responsible person - English: shaahin shahbazi Full name of responsible person - Persian: شاهین شهبازی Street address - English: خیابان حیدری بیمارستان امام خمینی Street address - Persian: Heidari street , Emamkhomeini hospital City - English: Ilam City - Persian: ایلام Province: Ilam Country: Iran (Islamic Republic of) Postal code: 6931975397 Phone: +98 84 3333 4500 Fax: Email: mdkabe@gmail.com Web page address: http://emamhospital.medilam.ac.ir
Protocol summary
Study aim
Assessment of effects of Bosentan therapy on outcomes of outpatients with COVID-19
Design
A double-blind randomized adaptive clinical trial study with a control group with a parallel design; on 300 patients. Block randomization method will be used for randomization.
Settings and conduct
This study will enroll adults presenting to the the clinic of Mostafa Khomaini hospital with mild, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management. Blinding in this study is double blind that the drug and placebo are labeled by the manufacturer as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling.
Participants/Inclusion and exclusion criteria
Inclusion criteria: One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 determined by PCR assay < 72 hours prior to randomization, Has at least one CDC defined risk factor for severe COVID-19 illness, Clinical team deems stable for outpatient management without supplemental oxygen, Has informed consent women of child bearing potential must agree to use at least one primary form of contraception for the duration of the study.
Exclusion criteria: Pregnancy or Lactation, Glibenclamide Consumption, Cyclosporine Consumption, Aminotransferases level> 3 times normal, Allergy to bosentan
Intervention groups
The study group will recieve tab Bosentan 62.5 mg twice daily and the control group will receive placebo.
Main outcome variables
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days
General information
Reason for update
Increasing sample size and description of outcomes
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053263N1
Registration date:2021-12-15, 1400/09/24
Registration timing:registered_while_recruiting
Last update:2022-03-12, 1400/12/21
Update count:5
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Shaahin Shahbazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 3960
Email address
mdkabe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-15, 1400/09/24
Expected recruitment end date
2022-05-14, 1401/02/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Bosentan with routine protocol on outcomes of high-risk outpatients with COVID-19 infection.
Public title
Bosentan for high-risk outpatients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 determined by PCR assay < 72 hours prior to randomization
Has at least one CDC defined risk factor for severe COVID-19 illness
Clinical team deems stable for outpatient management without supplemental oxygen
Has informed consent
women of child bearing potential must agree to use at least one primary form of contraception for the duration of the study
Exclusion criteria:
Pregnancy or Lactation
Glibenclamide Consumption
Cyclosporine Consumption
Aminotransferases > 3 times normal
Allergy to bosentan
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used for random allocation. The size of the blocks will randomly selected. There are 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations are considered for the intervention group and two allocations for the control group. Random Allocation Software will be used for this purpose. The concealment will done using sequentially numbered, sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study is double blind that the drug and placebo are labeled as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling.
Placebo
Used
Assignment
Parallel
Other design features
This study is add on trial study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Ilam University of Medical Sciences
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.MEDILAM.REC.1400.164
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
Disease progression within 15 days after randomization, on the basis of 11 points WHO clinical progression scale.
Timepoint
During 15 days from intervention
Method of measurement
clinical and paraclinical data
Secondary outcomes
1
Description
Thromboembolic events
Timepoint
within 30 days after intervention
Method of measurement
clinical and paraclinical data
2
Description
hospital-free days
Timepoint
within 30 days after intervention
Method of measurement
Observation
3
Description
Death from any cause
Timepoint
within 30 days after intervention
Method of measurement
Patient's medical record
Intervention groups
1
Description
Intervention group: The case group in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee), is treated with oral Bosentan 62.5 mg twice a day for 30 days.
Category
Treatment - Drugs
2
Description
Control group: Control group: Patients receive only the drugs used to treat COVID-19 (approved by the National Committee).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ilam Mostafa Khomaini hospital
Full name of responsible person
Shaahin Shahbazi
Street address
Tapeh Khargooshan St
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 84 3333 8228
Email
mdkabe@gmail.com
Web page address
http://mostafahospital.medilam.ac.ir/
2
Recruitment center
Name of recruitment center
Ilam emamkhomeiny hospital
Full name of responsible person
shaahin shahbazi
Street address
خیابان حیدری بیمارستان امام خمینی
City
Ilam
Province
Ilam
Postal code
6931975397
Phone
+98 84 3333 4500
Email
mdkabe@gmail.com
Web page address
http://emamhospital.medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 84 3333 8228
Email
mdkabe@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 84 3333 8228
Email
mdkabe@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 84 3333 8228
Email
mdkabe@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Shaahin Shahbazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology
Street address
Banghanjab Blv.
City
Ilam
Province
Ilam
Postal code
1639393939
Phone
+98 84 3333 8228
Email
mdkabe@gmail.com
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