| Trial registration number
|
IRCT20211203053263N1 |
Full text link
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
http://en.irct.ir/trial/60392
|
First author
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Shaahin Shahbazi
|
Contact
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
mdkabe@gmail.com
|
Registration date
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2021-12-15
|
Recruitment status
Last imported at : May 14, 2022, 7:12 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Completed
|
Study design
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
RCT
|
Allocation
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Randomized
|
Design
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Parallel
|
Masking
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Blind label
|
Center
Last imported at : March 13, 2022, 12:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
multi-center
|
Study aim
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Treatment
|
Inclusion criteria
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
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
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnancy or Lactation
Glibenclamide Consumption
Cyclosporine Consumption
Aminotransferases > 3 times normal
Allergy to bosentan
|
Number of arms
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
2
|
Funding
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Ilam University of Medical Sciences
|
Inclusion age min
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
18
|
Inclusion age max
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
100
|
Countries
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Iran
|
Type of patients
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Mild disease at enrollment
|
Severity scale
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
1: Mild disease at enrollment
|
Total sample size
Last imported at : April 30, 2023, 4:14 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
350
|
primary outcome
Last imported at : June 30, 2022, 10:41 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Disease progression within 15 days after randomization is defined as death or hospitalization.
|
Notes
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
|
Phase
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Phase 3
|
Arms
Last imported at : Dec. 16, 2021, 3:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
[{"arm_notes": "", "treatment_id": 2095, "treatment_name": "Bosentan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]
|