COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: 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 f
Sponsors
Ilam University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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
Exclusion criteria: Pregnancy or Lactation Glibenclamide Consumption Cyclosporine Consumption Aminotransferases > 3 times normal Allergy to bosentan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Thromboembolic events. Timepoint: within 30 days after intervention. Method of measurement: clinical and paraclinical data.;Death from any cause. Timepoint: within 30 days after intervention. Method of measurement: Patient's medical record.;Sarcopenia. Timepoint: Change from baseline at 1-12 months. Method of measurement: AWGS criteria.;Functional status. Timepoint: Change from baseline at 1-12 months. Method of measurement: Post-Covid Functional Scale.;Dyspnea. Timepoint: Change from baseline at 1-12 months. Method of measurement: MMRC dyspnea scale.;Fatigability. Timepoint: Change from baseline at 3-12 months. Method of measurement: chalder fatigue scale.;Sleep disorders. Timepoint: Change from baseline at 1-12 months. Method of measurement: Pittsburgh Sleep Questionnaire.;Brain fog. Timepoint: Change from baseline at 1-12 months. Method of measurement: Visual Analog Scale.;Loss of taste and smell. Timepoint: Change from baseline at 1-12 months. Method of measurement: clinical and paraclinical exam.;Change in Weight. Timepoint: Change from baseline at 1-12 months. Method of measurement: Weight scale.;Changes in Subject's quality of life. Timepoint: Change from baseline at 1-12 months. Method of measurement: Health Survey Questionnaire.;Assessment of sexual function. Timepoint: Change from baseline at 1-12 months. Method of measurement: questionnaire.;Food Intake assessment. Timepoint: Change from baseline at 1-12 months. Method of measurement: questionnaire.;Hospital-free days. Timepoint: within 30 days after randomization. Method of measurement: Medical record. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShaahin Shahbazi
Ilam University of Medical Sciences
Outcome results
None listed