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Secondary outcomes
#1
empty
Sarcopenia
Sarcopenia
empty
سارکوپنی
سارکوپنی
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
EWGSOP2 criteria
EWGSOP2 criteria
empty
معيار EWGSOP2
معيار EWGSOP2
#2
empty
Functional status
Functional status
empty
وضعيت عملکردي
وضعيت عملکردي
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Post-Covid Functional Scale
Post-Covid Functional Scale
empty
امتياز عملکردي پس از کوويد
امتياز عملکردي پس از کوويد
#3
empty
dyspnea
dyspnea
empty
نفس تنگي
نفس تنگي
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
MMRC dyspnea scale
MMRC dyspnea scale
empty
امتياز نفس تنگي MMRC
امتياز نفس تنگي MMRC
#4
empty
fatigability
fatigability
empty
خستگي
خستگي
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
chalder fatigue scale
chalder fatigue scale
empty
امتياز خستگي چالدر
امتياز خستگي چالدر
#5
empty
Sleep disorders
Sleep disorders
empty
اختلالات خواب
اختلالات خواب
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Pittsburgh Sleep Questionnaire
Pittsburgh Sleep Questionnaire
empty
پرسشنامه خواب پيتسبرگ
پرسشنامه خواب پيتسبرگ
#6
empty
Brain fog
Brain fog
empty
مه مغزي
مه مغزي
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Visual Analog Scale
Visual Analog Scale
empty
مقیاس آنالوگ بصری
مقیاس آنالوگ بصری
#7
empty
Loss of taste and smell
Loss of taste and smell
empty
کاهش چشايي و بويايي
کاهش چشايي و بويايي
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Visual Analog Scale
Visual Analog Scale
empty
مقیاس آنالوگ بصری
مقیاس آنالوگ بصری
#8
empty
thromboembolic events
thromboembolic events
empty
حوادث ترومبوآمبوليک
حوادث ترومبوآمبوليک
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
clinical and paraclinical exam
clinical and paraclinical exam
empty
معاينات کلينيکي و پاراکلينيک
معاينات کلينيکي و پاراکلينيک
#9
empty
Changes in serum level of CMP
Changes in serum level of CMP
empty
تغيير در سطح سرمي CMP
تغيير در سطح سرمي CMP
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Serum measurement
Serum measurement
empty
اندازه گيري سرمي
اندازه گيري سرمي
#10
empty
Change in Weight
Change in Weight
empty
تغيير در وزن
تغيير در وزن
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Weight scale
Weight scale
empty
ترازوي وزن
ترازوي وزن
#11
empty
Changes in Subject's quality of life
Changes in Subject's quality of life
empty
تغيير در کيفيت زندگي فرد
تغيير در کيفيت زندگي فرد
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
Health Survey Questionnaire
Health Survey Questionnaire
empty
پرسشنامه بررسی سلامت
پرسشنامه بررسی سلامت
#12
empty
Assessment of sexual function
Assessment of sexual function
empty
بررسي عملکرد جنسی
بررسي عملکرد جنسی
empty
Change from baseline at 3-12 months
Change from baseline at 3-12 months
empty
تغییر از پایه در 3-12 ماهگی
تغییر از پایه در 3-12 ماهگی
empty
questionnaire
questionnaire
empty
پرسشنامه
پرسشنامه
Protocol summary
Study aim
Determining the effect of bosentan on clinical outcomes of hospitalized patients with COVID-19 infection in comparison with routine protocol
Design
Double-blind randomized controlled clinical trial
Settings and conduct
In this study, COVID-19 patients, hospitalized in Shahid Mostafa Khomeini and Imam Khomeini hospitals with the mentioned inclusion and exclusion criteria will be studied. Bosentan and placebo tablets are similar, and patients and researchers are unaware of labeling. Bosentan 62.5 mg tablets will be given twice daily. Patients are followed up daily. After discharge, they will be followed up for 30 days from the time of intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Written informed consent; Age over 18 years; Laboratory-confirmed SARS-CoV-2 infection;
Exclusion Criteria:
• Pregnancy; Lactation; Glibenclamide Consumption; Cyclosporine Consumption; Aminotransferases > 3 times normal; Allergy to bosentan
Intervention groups
Oral Bosentan 62.5 mg, twice daily, for 30 days.
Main outcome variables
The time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a WHO 11 point clinical progression scale or live discharge from the hospital, whichever came first.
General information
Reason for update
Start recruitment process
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053263N2
Registration date:2022-02-26, 1400/12/07
Registration timing:prospective
Last update:2022-07-19, 1401/04/28
Update count:2
Registration date
2022-02-26, 1400/12/07
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
2022-02-27, 1400/12/08
Expected recruitment end date
2022-05-29, 1401/03/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of bosentan with routine protocol on clinical outcomes of hospitalized patients with COVID-19 infection.
Public title
Bosentan in hospitalized patients with COVID-19 infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written informed consent prior to initiation of study.
Age over 18 years.
Laboratory-confirmed SARS-CoV-2 infection determined by PCR less than 72 hours before randomization.
Illness of any duration, and at least one of the following:Radiographic infiltrates by imaging , OR Clinical assessment (evidence of rales/crackles on exam) AND SpO2 ≤ 94% on room air, OR Requiring mechanical ventilation and/or supplemental oxygen.
Women of childbearing 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:
200
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 be 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 an adaptive and add on trial.
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
2022-02-21, 1400/12/02
Ethics committee reference number
IR.MEDILAM.REC.1400.220
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
The time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a WHO 11 point clinical progression scale or live discharge from the hospital, whichever came first.
Timepoint
During hospitalization
Method of measurement
WHO 11 point clinical progresson scale
Secondary outcomes
1
Description
Proportion of patients in each category of the WHO 11 point clinical progression scale on day 30 after randomization
Timepoint
Day 30
Method of measurement
WHO 11 point clinical progression scale
2
Description
Duration of mechanical ventilation
Timepoint
During hospitalization
Method of measurement
Mechanical ventilation, Observation
3
Description
Duration of hospitalization in survivors
Timepoint
During intervention
Method of measurement
Observation, Medical report
4
Description
The composite of symptomatic deep venous thrombosis; pulmonary embolism; arterial thromboembolism; myocardial infarction; ischemic stroke, up to 30 days after treatment initiation
Timepoint
30 days from intervention
Method of measurement
Observation
5
Description
30 days mortality
Timepoint
30 days from intervention
Method of measurement
Observation, Medical report
6
Description
Sarcopenia
Timepoint
Change from baseline at 3-12 months
Method of measurement
EWGSOP2 criteria
7
Description
Functional status
Timepoint
Change from baseline at 3-12 months
Method of measurement
Post-Covid Functional Scale
8
Description
dyspnea
Timepoint
Change from baseline at 3-12 months
Method of measurement
MMRC dyspnea scale
9
Description
fatigability
Timepoint
Change from baseline at 3-12 months
Method of measurement
chalder fatigue scale
10
Description
Sleep disorders
Timepoint
Change from baseline at 3-12 months
Method of measurement
Pittsburgh Sleep Questionnaire
11
Description
Brain fog
Timepoint
Change from baseline at 3-12 months
Method of measurement
Visual Analog Scale
12
Description
Loss of taste and smell
Timepoint
Change from baseline at 3-12 months
Method of measurement
Visual Analog Scale
13
Description
thromboembolic events
Timepoint
Change from baseline at 3-12 months
Method of measurement
clinical and paraclinical exam
14
Description
Changes in serum level of CMP
Timepoint
Change from baseline at 3-12 months
Method of measurement
Serum measurement
15
Description
Change in Weight
Timepoint
Change from baseline at 3-12 months
Method of measurement
Weight scale
16
Description
Changes in Subject's quality of life
Timepoint
Change from baseline at 3-12 months
Method of measurement
Health Survey Questionnaire
17
Description
Assessment of sexual function
Timepoint
Change from baseline at 3-12 months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: The study 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. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events.
Category
Treatment - Drugs
2
Description
Control group: The control group, in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee), receive a placebo twice a day for 30 days. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mostafa Khomaini hospital of Ilam
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
Imam Khomeini Hospital of Ilam
Full name of responsible person
Shaahin Shahbazi
Street address
Heidari street.
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
Ilam University of Medical Sciences
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
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
Internal Medicine
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
Internal Medicine
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
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