Novel Technologies to Quickly Act on Outbreak Data

Decentralized Trials and Self-blood Collection

The need to reach potential research subjects outside clinical centers grew urgent during the COVID-19 pandemic, as hospitals became overwhelmed with surges in cases and many isolated at home. Our team partnered with the Naval Health Research Center (NHRC) and Tripler Army Medical Center (TAMC) to develop and deploy a decentralized study of ambulatory COVID-19 cases and their close contacts. Research subjects enrolled at NHRC never set foot in a clinic for study visits, nor did they have in-person contact with the study team. Blood collection was enabled using a novel technology, the Tasso micro-needle self-blood collection device.

The Tasso Serum Separator Tube (SST) (Tasso Inc., WA, USA) is a single-use, sterile, disposable, integrated device for self-collection of capillary blood by the user. The device comprises a lancet assembly and a detachable reservoir collection unit, designed to collect up to 300 μL capillary blood that can be processed to generate serum at a central processing lab for downstream analysis.

Point-of-care biomarker assay platforms

Triage decisions became critical during the pandemic, but clinicians had very little to guide them on which patients to admit to the hospital and which to discharge to isolate at home. We set out to develop a rapid point-of-care test for the risk of hospitalization of recently diagnosed COVID-19 patients. This technology aims to quickly classify those patients recommended for hospitalization versus those who could isolate at home. We partnered with LightDeck, as their technology platform has unique capabilities for point-of-care (POC) host-response biomarker assays. We evaluated potential COVID-19 host-response biomarkers for outcomes using a bank of clinical samples covering both hospitalized and non-hospitalized patients. Out of that evaluation, we demonstrated that two specific markers, C-reactive protein (CRP) and inducible-protein 10 (IP-10 or CXCL-10) are markedly elevated in those patients who are hospitalized. Hospitalization risk prognosis/ triage could provide significant benefit during pandemics or biothreat events when resources (e.g., nurses, ICU beds, ventilators, etc.) are limited.

Wearable biosensors

Remote monitoring of vital signs with sophisticated personalized algorithms has the potential to provide a non-invasive means to assess disease progression and provide early indication of infection. We have partnered with PhysIQ, a company that specializes in collecting and analyzing continuous physiological data acquired from wearable biosensors, as well as NHRC, TAMC, Duke University, and Johns Hopkins University to deploy wearable biosensors in subjects with COVID-19 and their close contacts. 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.

POCUS

From austere to tertiary care settings, Point-of-Care Ultrasound (POCUS) is an emerging technology that could guide life-saving treatment for the Warfighter. POCUS could be used to identify both lung pathology and causes of shock in the field. However, algorithms to guide clinicians and medics on the appropriate use of this promising tool are needed. HJF has developed and modified clinical research protocols for the deployment of POCUS. Deployment included training of study personnel, collection of associated clinical data and imaging, establishment of required agreements, as well as engagement of subject matter experts for training and annotation of images.

Technologies that help health care providers make informed treatment decisions as well as those giving patients ways to provide information to their
caregivers remotely have the capacity to improve outcomes for service members as well as the general public, whether in a pandemic situation or not. ACESO is committed to furthering such studies and creating results that bring these benefits to life.

Founded in 2010, the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO) is a consortium consisting of U.S. Government, non-profit, academic and industry partners. ACESO’s mission is to improve survival for patients with sepsis through development of host-based diagnostic and prognostic assays and evidence- based clinical management. ACESO is specifically focused on developing solutions to guide clinical decision-making in settings where a modern intensive care unit (ICU) is not available, including military deployments to areas with long medical evacuation chains, medical centers in low- and middle-income countries, and pandemic or other public health emergency settings.

The HJF/ACESO team leveraged our advances in sepsis at the start of the COVID-19 pandemic to rapidly translate and deploy technologies to better understand COVID-19 and develop solutions.

For more information, see:
https://www.aceso-sepsis.org https://www.hjf.org/news/hjf-filter-covid-19

Acknowledgments:
Dr. Danielle Clark, Director & Co-Founder of ACESO and HJF Scientific Director;
Dr. Josh Chenoweth, Director of Experimental & Translational Biology, ACESO and HFJ Scientific Director; and Kathryn McKean, Communications Coordinator, ACESO/HJF