Bosentan in hospitalized patients with COVID-19 infectio
Phase 3
- Conditions
- COVID-19.U07.1COVID-19, virus identified
- Registration Number
- IRCT20211203053263N2
- Lead Sponsor
- Ilam University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method