Monitoring and clinical assessments of COVID-19 patients from home. We are conducting an ongoing study with RedHill, a specialty pharmaceutical company, to test the efficacy and safety of a treatment for Covid-19. Studies to date conducted on treatments like remdesivir have focused on intravenous medications for hospitalized patients, despite the fact that the virus is highly contagious and that the majority of patients with COVID-19 fortunately, do not require hospitalization. They are told to self-isolate, rest, and take symptomatic medications. While some outpatient studies have been performed, most have been with parenteral medications, requiring significant infusion time in the clinic or ER. In addition, many of these studies require multiple return visits to the medical facility, inconveniencing acutely ill patients and posing a hazard for staff.This highlights a significant unmet medical need for an oral, easily administered medication for treatment of symptomatic COVID-19 patients at home. Until recently, it was assumed that patients needed to travel for certain types of research related assessments. 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, opening up a world of opportunity for more convenient capture of real-world data.
Evaluate the safety and efficacy on non-hospitalized COVID-19 patients of an oral investigational drug which has demonstrated in vitro activity against of SARS-CoV-2 viral replication.
Participants are being enrolled through both virtual and brick and mortar sites. Following examination and a test to confirm that they are COVID positive, participants are given or shipped the study drug plus several devices to collect telemetric information and patient-reported information to measure safety and efficacy signals.
Vitals measured via devices include:
In addition to this autonomous data collection – the protocol includes visits by a home healthcare nurse at various points during the study. This allows patients to continue to recover in the comfort of their own home while ensuring their safety by monitoring them very carefully. Home healthcare nurses perform 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.
Recruitment is ongoing, multiple participants have been enrolled in the US and the study is expanding to several other countries.
While it is too soon to point to any results, an immediate benefit of this approach is the level of convenience provided to participants. By structuring the study for only a single initial site visit and then following with a combination of ePRO, device use and in-home visits, we minimize the disruption inpatients’ lives while cost effectively collecting high quality and reliable data.