Comparison of Bosentan with routine protocol on outcomes of high-risk outpatients with COVID-19 infection.

Assessment of effects of Bosentan therapy on outcomes of outpatients with COVID-19

A double-blind randomized adaptive clinical trial study with a control group with a parallel design; on 300 patients. Block randomization method will be used for randomization.

This study will enroll adults presenting to the the clinic of Mostafa Khomaini hospital with mild, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management. Blinding in this study is double blind that the drug and placebo are labeled by the manufacturer 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.

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 level> 3 times normal, Allergy to bosentan

The study group will recieve tab Bosentan 62.5 mg twice daily and the control group will receive placebo.

Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days

To update sample size

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 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.