Assessment of effects of Bosentan therapy on outcomes of outpatients with COVID-19
Design
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.
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
Subject clinical status (10 point WHO clinical progression scale)
General information
Reason for update
Acronym
Coronavirus disease
IRCT registration information
IRCT registration number:IRCT20211203053263N1
Registration date:2021-12-15, 1400/09/24
Registration timing:registered_while_recruiting
Last update:2021-12-15, 1400/09/24
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
2021-12-11, 1400/09/20
Expected recruitment end date
2022-03-11, 1400/12/20
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
2021-11-29, 1400/09/08
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
Subject clinical status (10 point WHO clinical progression scale)
Timepoint
day 15
Method of measurement
WHO 10 point progresson scale
Secondary outcomes
1
Description
National early warning scale
Timepoint
Days: 3,5,8,11,13,15
Method of measurement
pulse oximeter, thermometer, sphygmomanometer
2
Description
Subject clinical status (10 point WHO clinical progression scale)
Timepoint
Days: 3,5,8,11,13,15
Method of measurement
WHO 10 point progresson scale
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
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