Monitoring and clinical assessments of COVID-19 patients from home
We are currently planning a study with 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. Yet the majority of patients with COVID-19 are, fortunately, not being hospitalized. They are told to self-isolate, rest, and take symptomatic medications. This highlights a significant unmet medical need for an oral, easily administered medication for treatment of symptomatic COVID-19 patient 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
We will conduct a randomized, double-blind, placebo-controlled hybrid study. Participants will enroll at a clinical site and be sent home with study drug and several devices to collect both telemetric information and patient-reported information in order to measure the safety and efficacy of the investigational treatment. Measurements will include temperature, respiratory and pulse rates, blood pressure, pulse oximetry, electrocardiogram (ECG) and weight
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.
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 are able to minimize the disruption inpatients’ lives while cost effectively collecting high quality and reliable data.
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