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IRCT20211203053263N2 IRCT 2022-02-26 Ilam University of Medical Sciences Bosentan in hospitalized patients with COVID-19 infection Comparison of the effect of bosentan with routine protocol on clinical outcomes of hospitalized patients with COVID-19 infection. 2022-02-27 anticipated 200 Complete https://irct.ir/trial/61743 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is an adaptive and add on trial, 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 be 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 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 for 30 days. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events. Intervention 2: Control group: The control group, in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee), receive a placebo twice a day for 30 days. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events. 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 Ilam University of Medical Sciences
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) 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. 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 Placebo 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 for 30 days. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events. Control group: The control group, in addition to the drugs used in the treatment of COVID-19 (approved by the National Committee), receive a placebo twice a day for 30 days. Patients will be followed for 30 days for recovery or discharge, duration of mechanical ventilation dependency, length of hospital stay, mortality, and thromboembolic events. 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. 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 from baseline at 3-12 months. Method of measurement: Health Survey Questionnaire. Assessment of sexual function. Timepoint: Change from baseline at 3-12 months. Method of measurement: questionnaire. Ilam University of Medical Sciences Approved 2022-02-21 Research Ethics Committees of Ilam University of Medical Sciences Banghanjab Blv. Ilam Ilam Iran (Islamic Republic of)