COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: The study 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: 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
Exclusion criteria: Pregnancy or Lactation Glibenclamide Consumption Cyclosporine Consumption Aminotransferases > 3 times normal Allergy to bosentan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Proportion of patients in each category of the WHO 11 point clinical progression scale on day 30 after randomization. Timepoint: Day 30. Method of measurement: WHO 11 point clinical progression scale.;Duration of mechanical ventilation. Timepoint: During hospitalization. Method of measurement: Mechanical ventilation, Observation.;Duration of hospitalization in survivors. Timepoint: During intervention. Method of measurement: Observation, Medical report.;The composite of symptomatic deep venous thrombosis; pulmonary embolism; arterial thromboembolism; myocardial infarction; ischemic stroke, up to 30 days after treatment initiation. Timepoint: 30 days from intervention. Method of measurement: Observation.;30 days mortality. Timepoint: 30 days from intervention. Method of measurement: Observation, Medical report.;Sarcopenia. Timepoint: Change from baseline at 3-12 months. Method of measurement: EWGSOP2 criteria.;Functional status. Timepoint: Change from baseline at 3-12 months. Method of measurement: Post-Covid Functional Scale.;Dyspnea. Timepoint: Change from baseline at 3-12 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 3-12 months. Method of measurement: Pittsburgh Sleep Questionnaire.;Brain fog. Timepoint: Change from baseline at 3-12 months. Method of measurement: Visual Analog Scale.;Loss of taste and smell. Timepoint: Change from baseline at 3-12 months. Method of measurement: Visual Analog Scale.;Thromboembolic events. Timepoint: Change from baseline at 3-12 months. Method of measurement: clinical and paraclinical exam.;Changes in serum level of CMP. Timepoint: Change from baseline at 3-12 months. Method of measurement: Serum measurement.;Change in Weight. Timepoint: Change from baseline at 3-12 months. Method of measurement: Weight scale.;Changes in Subject's quality of life. Timepoint: Change | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactIlam University of Medical Sciences
Ilam University of Medical Sciences
Outcome results
None listed