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.
For more information, click here.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.