Bosentan for high-risk outpatients with COVID-19

Phase 3

• Conditions: COVID-19.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20211203053263N1
• Lead Sponsor: Ilam University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression within 15 days after randomization is defined as death or hospitalization. Timepoint: During within 15 days after intervention. Method of measurement: clinical and paraclinical data.