University Hospitals to study one of the first investigational drugs for outpatients in fight against COVID-19

Monday, February 22, 2021

One of the first U.S. sites for Phase 2/3 clinical trial of once a day, orally-administered study drug RHB-107, also referred to as Upamostat

CLEVELAND -- University Hospitals (UH) will open as one of the first sites in the nation for a clinical trial evaluating an investigational drug for COVID-19 in patients who do not require hospitalization.
 
The study drug is a novel, orally-administered serine protease inhibitor called RHB-107, also known as Upamostat, which has demonstrated antiviral and potential tissue-protective effects. Upamostat is being evaluated by RedHill Biopharma in a Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. 
 
Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at UH and Director, UH Clinical Research Center, is the Principal Investigator of the study at UH. 
 
“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. McComsey. “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.”
 
Study participants will be randomly assigned to either the study drug or placebo, and the sponsor, study team, and participants will not know which one is assigned. Participants will take the study drug or placebo by mouth, once per day for up to 14 days.
 
“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.
 
Enrollment is competitive and open in several study sites nationally, and researchers plan to enroll a total of 310 participants into this study.
 
Participants must be 18 years or older, started having symptoms or had a positive test for COVID-19 disease within three days from the planned start of study treatment, do not require hospitalization, and able to use a smartphone for the study.
 
Eligible participants will take study drug or placebo in a capsule by mouth once a day for up to 14 days. This study only has one in-person clinic visit, then participants will be monitored closely for the duration of the study, up to 57 days, through phone apps, telehealth, and by home health care visits. 


RedHill Biopharma (NASDAQ: RDHL), a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases, is the sponsor of the study and has selected UH and several other sites in the United States.
 
For more information about the study, please see uhhospitals.org/upamostat or call 1-833-788-7425, or visit ClinicalTrials.gov, study ID:   NCT04723537
 
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