Amidst the global push to vaccinate enough people to establish COVID-19 herd immunity, the medical and pharma communities continue the search for effective treatments for patients infected with the virus. ObvioHealth and RedHill Biopharma recently launched a COVID-19 treatment trial based on remote patient monitoring (RPM) using biometric sensing devices in patients’ homes.
The at-home RPM trial is a noteworthy example of an all-hands-on-deck approach to patient care during the pandemic. ObvioHealth is a Virtual Research Organization (VRO). ObvioHealth developed a downloadable patient-centric smartphone app people use to participate in clinical trials from their homes. Prior to this new trial, ObvioHealth ran 40 clinical trials in 14 areas of medicine in 28 countries.
RedHill Biopharma develops pharmaceutical products for gastrointestinal and infectious disease. The trial with ObvioHealth will test the safety and efficacy of RedHill’s RHB-107 (upamostat) for treating COVID-19. RHB-107 is an orally-administered pharmaceutical that has antiviral and potential tissue-protect effects. RHB-107 targets human cells, not the virus, according to the developer. RedHill expects the treatment to work with new COVID-19 variants.
The U.S.-based study is a hybrid trial with more than 300 asymptomatic COVID-19 patients who don’t need to be hospitalized. The trial will include devices, the smartphone app, and visits by home healthcare professionals. The study will give patients RHB-107 and five FDA 510(k) cleared devices to take home. The ObvioHealth app collects patient-reported and device transmitted data. The devices will report patient temperature, respiratory and pulse rates, blood pressure, pulse oximetry, ECG, and weight. During home healthcare visits nurses will check on patients, observe patient-reported data capture using the devices, collect blood samples, and perform virus PCR swabs.
In addition to allowing patients to receive treatment while at home, the hybrid treatment will reduce exposure for health care personnel and patients while also keeping the patients quarantined during treatment. This method also also enables research on RHB-107 while protecting the researchers from exposure.
The ObvioHealth and RedHill trial is particularly notable from our perspective in its use of RPM and various bio-sensing devices with several layers of benefits while enabling research related to an urgent health threat.