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University Hospitals to study drug formulated to assist outpatients battling COVID-19

More than 300 people are expected to take part in the study nationwide.

CLEVELAND — As the state of Ohio continues its fight against the coronavirus pandemic and local health officials work to effectively distribute the vaccine, health care systems are doing what they can to better treat COVID-19 patients. 

On Monday, University Hospitals announced that it will become one of the first locations in the nation to participate in a clinical trial evaluating an investigational drug for outpatients, not requiring hospitalization, diagnosed with COVID-19. 

The drug, known as RHB-107 or Upamostat, has "demonstrated antiviral and potential tissue-protective effects," according to a press release. 

“Laboratory studies have shown that Upamostat may prevent attachment and entry of SARS-CoV-2 virus, commonly called COVID-19, particles to cells. Therefore, it is being studied to see if it helps people with coronavirus infections at an early stage before they become severe and require hospitalization,” said Dr. Grace McComsey, MD, the principal investigator of the study. “This is what we need currently; we need early COVID-19 studies to keep people at home and out of the hospital and keep COVID-19 as a mild illness that does not progress.”

The novel, orally-administered serine protease inhibitor, is being evaluated by RedHill Bipharma, a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. 

More than 300 people are expected to take part in the study nationwide. Participants, who must be 18 years or older, will be randomly assigned to either the study drug or the placebo. The study requires the drug to be taken once per day, orally, for 14 days. Patients will be monitored closely for nearly 60 days through applications, telehealth, and smartphones. 

“The purpose of this research study is two-fold: Firstly, to ascertain the most appropriate dose and secondly, to test the safety of the drug and to see if it can help people with early COVID-19 infection. Participants will take Upamostat or placebo just once per day,” said Dr. McComsey.

RedHill Biopharma is the sponsor of the study and has selected UH and several other sites in the United States for testing and evaluation. 

For more information about the study, click here, or call 1-833-788-7425, or visit ClinicalTrials.gov, study ID: NCT04723537