What You Should Know:
– RedHill Biopharma, a specialty biopharmaceutical company, and ObvioHealth, a global virtual research organization, have partnered on the largest remote clinical study for a new at-home COVID-19 treatment, Upamostat.
– The trial is being performed completely remotely in patients’ homes using ObvioHealth’s clinical trial ecosystem including digital devices, a patient-centric smartphone application and home healthcare visits.
– The randomized, double-blind, placebo-controlled hybrid study will include more than 300 COVID-19-positive participants and evaluate the effectiveness of Upamostat against the virus. Patients are provided with Upamostat and five 510(k)-cleared devices to begin treatment while ObvioHealth’s platform collects both telemetric information and patient-reported information. Key remote safety monitoring includes patients’ heart rate, respiratory rate and temperature, which will be monitored continuously via a biosticker device, and their pulse oximetry, which is monitored twice daily.
– Home healthcare nurses will make four in-home visits to check-in on patients, collect blood samples for certain laboratory parameters, perform virus PCR swabs at home, and assist in certain patient-reported data capture, using devices provided to participants at home.