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ObvioHealth, a global virtual research organization, has announced the launch of a hybrid clinical trial for the treatment of COVID-19, using a study design with digital data capture to remotely monitor patient vitals. This US Phase II/III study will examine the safety and efficacy of RedHill Biopharma’s RHB-107 (upamostat), using ObvioHealth’s clinical trial ecosystem, including digital devices, a patient-centric smartphone application and home healthcare visits.
RHB-107 is an orally-administered serine protease inhibitor with antiviral and potential tissue-protective effects which targets human cells rather than the virus itself and is expected to be effective against new viral strains. The two-part randomized, double-blind, placebo-controlled hybrid U.S. Phase II/III study is enrolling more than 300 patients with symptomatic COVID-19, who do not require hospital care, to evaluate the safety and effectiveness of RHB-107.
Patients will be sent home with RHB-107 and five 510(k)-cleared devices to begin treatment. ObvioHealth’s platform is collecting both telemetric and patient-reported information; biomarkers continuously gathered from the devices will include patients’ temperature, respiratory and pulse rates, blood pressure, pulse oximetry, electrocardiogram (ECG) and weight.
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