Metro Detroit residents needed for oral COVID-19 treatment clinical trial
Metro Detroit residents who have been recently diagnosed with COVID-19 or are currently ill after being exposed are needed for a clinical trial for a new virus treatment.
Phase 2/3 of the national study will examine the safety and efficacy of Raleigh, North Carolina-based RedHill Biopharma's drug RHB-107, or upamostat. The medication is an orally administered serine protease inhibitor with antiviral and potential tissue-protective effects that target human cells rather than the COVID-19 virus itself
Researchers are enrolling 300 patients with symptomatic COVID-19 who do not require hospital care in a randomized, double-blind study with placebos.
The trial requires one visit toHenry Ford Hospital on West Grand Boulevard in Detroit at the beginning of the study and the remainder of the trial will be self-monitoring at home with devices to monitor vitals. Nurses will make in-home visits to check in on patients, collect blood samples and test for the virus using PCR swabs at home.
While many previous COVID-19 treatment studies have focused on intravenous medications for hospitalized patients, there's a need to treat the majority of patients who are battling the virus at home, said Dr. Terry Plasse, medical director of RedHilll Biopharma.
"The ability to treat patients early in the course of the COVID-19 disease, with an oral therapy that shows promise against emerging viral variants and is designed to be used outside the hospital, has the potential to be a game-changer in managing this disease,” Plasse said. “Until recently, it was assumed that patients needed to travel to clinical sites for assessments of vital signs. However, inroads in the development of accurate and 510(k)-cleared medical devices for in-home use enable patients in clinical trials to do much of this from home."
"Clinical studies involving COVID-19 patients introduce significant risks, requiring constant monitoring and careful practices to avoid exposure to the virus," said Ivan Jarry, CEO of ObvioHealth, a global research organization that launched the trial. "This innovative trial allows participants to remain quarantined during treatment while remotely providing valuable data to researchers, reducing risk of spread."
Interested participants can visit https://1nhealth.com/feeling-the-symptoms/#details for more information and to pre-qualify for the trial.