| Trial registration number
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IRCT20211203053263N2 |
Full text link
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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http://en.irct.ir/trial/61743
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First author
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Shaahin Shahbazi
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Contact
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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mdkabe@gmail.com
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Registration date
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2022-02-26
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Recruitment status
Last imported at : May 29, 2022, 12:11 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Completed
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Study design
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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RCT
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Allocation
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Randomized
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Design
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Parallel
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Masking
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Blind label
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Center
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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multi-center
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Study aim
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Treatment
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Inclusion criteria
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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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.
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Exclusion criteria
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
|
Pregnancy or Lactation
Glibenclamide Consumption
Cyclosporine Consumption
Aminotransferases > 3 times normal
Allergy to bosentan
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Number of arms
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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2
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Funding
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Ilam University of Medical Sciences
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Inclusion age min
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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18
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Inclusion age max
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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100
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Countries
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Iran
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Type of patients
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Moderate/severe/critical disease at enrollment
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Severity scale
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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5: Moderate/severe/critical disease at enrollment
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Total sample size
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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200
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primary outcome
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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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.
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Notes
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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Phase 3
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Arms
Last imported at : Feb. 26, 2022, 7:30 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)
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[{"arm_notes": "", "treatment_id": 2095, "treatment_name": "Bosentan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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