]>
IRCT20211203053263N1 IRCT 2021-12-15 Ilam University of Medical Sciences Bosentan for high-risk outpatients with COVID-19 Comparison of Bosentan with routine protocol on outcomes of high-risk outpatients with COVID-19 infection. 2021-12-15 anticipated 350 Complete https://irct.ir/trial/60392 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is add on trial study, Randomization description: Permuted Block Randomization will be used for random allocation. The size of the blocks will randomly selected. There are 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations are considered for the intervention group and two allocations for the control group. Random Allocation Software will be used for this purpose. The concealment will done using sequentially numbered, sealed envelopes, Blinding description: Blinding in this study is double blind that the drug and placebo are labeled as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and the person distributing the medicine does not know about this labeling. 3 COVID-19. 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 for 30 days. Intervention 2: Control group: Control group: Patients receive only the drugs used to treat COVID-19 (approved by the National Committee). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Shaahin Shahbazi
Banghanjab Blv.
Ilam Iran (Islamic Republic of) 1639393939 +98 84 3333 8228 mdkabe@gmail.com Ilam University of Medical Sciences scientific Shaahin Shahbazi
Banghanjab Blv.
Ilam Iran (Islamic Republic of) 1639393939 +98 84 3333 8228 mdkabe@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years no limit Both Pregnancy or Lactation Glibenclamide Consumption Cyclosporine Consumption Aminotransferases > 3 times normal Allergy to bosentan U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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 for 30 days. Control group: Control group: Patients receive only the drugs used to treat COVID-19 (approved by the National Committee). 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. 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. Ilam University of Medical Sciences Approved 2021-12-15 Research Ethics Committees of Ilam University of Medical Sciences Banghanjab Blv. Ilam Ilam Iran (Islamic Republic of)