PhysIQ Inc., Johns Hopkins University, Duke University and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), on May 4 announced a collaboration to deploy physIQ’s platform to support a clinical trial to evaluate investigational products for early treatment and post-exposure prophylaxis of COVID-19.
In this 18-month study, continuous monitoring with sophisticated personalized algorithms will be deployed to evaluate predictive power of physiologic signals to assess disease progression and provide early indication of infection. These signals will also support the evaluation of novel products for treatment and prevention of COVID-19.
PhysIQ, a company that specializes in collecting and analyzing continuous physiological data acquired from wearable biosensors, will deploy its pinpointIQ platform at Johns Hopkins University and Duke University in support of the study. Confirmed COVID-19 positive individuals and patients at high risk of exposure will wear a clinical-grade biosensor that continuously streams data to pinpointIQ where advanced FDA-cleared analytics will process the raw biosensor data. In addition to capturing continuous physiological data, patients will also use physIQ’s mobile application to submit pulse oximeter measurements and report symptoms.
Dr. Danielle Clark, Co-founder and Director of the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) program, administered by HJF, is the protocol PI.
“Given the challenge of what appears to be an ever-evolving virus, the opportunity to deploy cutting-edge technology to study COVID-19 is paramount to ultimately understanding its progression and aid in the fight to defeat it,” Clark said. “This is our second clinical study with physIQ, and we are excited to expand our relationship by continuing to trial this innovative diagnostic technology.”
ACESO’s mission is to improve survival for patients with severe infections through development of host-based diagnostic and prognostic tools and evidence-based clinical management strategies.
Among the specific objectives of the study are to use continuous physiological data to characterize immune response to infection, evaluate novel machine-learning-enabled diagnostic and prognostic tools, and evaluate the efficacy of emergency investigational new drug therapies that may be administered to enrolled participants. For exploratory purposes, the study also seeks to identify baseline and longitudinal host and pathogen factors predictive of progression to guide clinical triage and treatment decision.
“We are excited to expand our long standing collaborative work with Dr. Clark and team up with our collaborators at Duke and Johns Hopkins,” said Stephan Wegerich, physIQ’s Chief Science Officer. “This continued work will expand our understanding of COVID-19 infection severity trajectories and will provide the data necessary for developing a continuous, and objective biosensor-based analytic to serve as a proxy for subjective patient severity surveys.”
PhysIQ’s technology is currently being utilized in observational and interventional studies across multiple protocols. Given the nature of the continuous, near real-time data collection capability of the pinpointIQ platform, and because all data are stored and processed in the cloud, and available for viewing through a secure web-interface, clinicians have rapid access to the streaming data for use in patient monitoring and researchers have access to offline data to support ongoing COVID-19 related research initiatives.
This collaboration is funded by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) on behalf of the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)).
Read more: https://www.hjf.org/news/PhysIQ-partner-study-covid-19