University Hospitals will serve as one of the first sites in the nation for a clinical trial evaluating an investigational drug for COVID-19 patients who don’t need to be hospitalized, according to a news release.
A novel, orally-administered serine protease inhibitor called RHB-107 has demonstrated antiviral and potential tissue-protective effects, according to the release. RedHill Biopharma (NASDAQ: RDHL) is evaluating the study drug, also known as Upamostat, in a Phase 2/3 study for treating patients with symptomatic COVID-19 who don’t require inpatient care.
A specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases, RedHill Biopharma is sponsoring the study at UH and several other U.S. sites.
“Laboratory studies have shown that Upamostat may prevent attachment and entry of SARS-CoV-2 virus, commonly called COVID-19, particles to cells,” said Dr. Grace McComsey, vice president of research and associate chief scientific officer at UH, in a provided statement. “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. 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.”
McComsey, also UH Clinical Research Center director, is the principal investigator of the study at UH. The study aims to ascertain the most appropriate dose, test the safety of the drug and see if it can help people with early COVID-19, she said in the release.
Enrollment is competitive and open in several study sites nationally. Researchers plan to enroll a total of 310 participants, who will be randomly assigned to take either the study drug or a placebo by mouth, once per day for up to 14 days, according to the release. Participants must be 18 years or older, be able to use a smartphone and have begun having symptoms or received a positive test for COVID-19 within three days from the planned start of study treatment and not require hospitalization.
This study has one in-person clinic visit, after which, participants will be monitored for the duration of the study (up to 57 days) via phone apps, telehealth and home health care visits, according to the release.