[January 12, 2021]

Project Coromec Enables COVID19 Risk Assessment for Hospitalization Outcomes and Real Time Epidemiology Efficacy

Aventyn Inc. COVID19 Challenge: SARS-CoV-2 is a beta coronavirus similar to SARS and Middle East respiratory syndrome (MERS), the coronaviruses responsible for the last two epidemics in 2003 and 2012, respectively. At the time of this release, more than 86 million infections have been reported worldwide, with over 1.8 million having died due to COVID19 in a fast-moving pandemic. The United States has reported the highest number of cases and deaths in the world. As the pandemic has overwhelmed healthcare systems, better therapies are desperately needed to prevent positive cases that are asymptomatic or mildly symptomatic from worsening, leading to hospitalization. Individuals diagnosed with COVID19 can manifest a litany of symptoms, including fever, dry cough, dyspnea, myalgia, and fatigue. Within a few days of symptom onset, some patients rapidly progress to respiratory failure requiring mechanical ventilation. Elderly patients and those with medical comorbidities such as diabetes, hypertension, and obesity, underlying cardio-pulmonary disease, immunocompromised state, kidney disease, and cancer are at greater risk of developing worsening comorbidities rapidly progressing to Acute Respiratory Distress Syndrome and multi-organ failure, requiring hospitalization and prolonged care in the ICU. These patients also have a higher mortality rate compared to younger patients without comorbid conditions. A standardized approach to risk screening, testing, and early treatment preventing hospitalizations and treating patients with COVID19 continues to be a global challenge lacking peer-reviewed clinical validation.

While the COVID19 pandemic continues to spread globally, a clear role for innovative digital health technology has emerged as needed for assessing COVID19 infection spread, screening, diagnostics, disease management, and remote patient monitoring. In recent years, digital health generally has been innovating around managing health information for claims processing, optimizing hospital care delivery, and better understanding personalized health insights for implementing preventive, long-term care and wellness programs. With the pandemic there is a critical need for consensual, secure contact tracing apps with deidentified location detection and user acceptance.

Project Coromec, registered under ClinicalTrials.Gov (NCT04678193), is a real-time COVID19 epidemiology registry aimed at assessing the feasibility of monitoring enrolled subjects' infection progress using the Vitalbeat® digital therapeutics monitoring platform for remote patient monitoring and integrated chronic disease management with mobile apps, AI-bots, IoT Wearables, and cloud computing algorithms in collaboration with Intel (News - Alert) Corp., clinicians and scientists from Abrazo Health, Karolinska Institute, ASU College of Health Solutions, and global collaborators. The Coromec registry is a real-time epidemiology solution deploying the Vitalbeat health application platform developed by digital therapeutics company Aventyn (News - Alert), Inc., enabling pandemic public health stakeholders to report and assess subject risk prediction in order to avoid hospitalization. Healthcare is becoming more intelligent, distributed, and personalized. Intel technologies are helping to enable a new era of smart, connected, value-based patient care, remote edicine and monitoring, individually tailored prehospital treatment plans, and more-efficient clinical operations. This digital health technology platform aims to assess predictors of risk of hospitalization due to COVID19, assess what preventive strategies are being used, and the efficacy of treatment strategies for avoiding hospitalization. Subject participants can enroll at the study site Project Coromec.

"We see a grave need for the immediate development of digital tools for reporting of self-illness, testing, and actions taken by individuals through a mobile phone application that is freely downloadable and allows for geographic monitoring with subject consent at enrollment," said Kris Vijay, MD FACC, Project Coromec study chair. "Secondly, we call for immediate and mandatory daily hospital census reporting of hospitalized and critical ill COVID19 patients. We need organized solutions concerning redeployment of physical and human resources where they are needed most to track infection spread, and risk assessment to better utilize critical hospital resources."

"Project Coromec aims to enable real-time epidemiology integrating sources of information that include daily if not hourly reporting of cases stratified to indicate levels of infection, asymptomatic positive patients self-quarantined or at home, mild symptomatic positive patients at home, patients hospitalized in medical wards, and ICU and ventilator-dependent illness, as well as demise," said Michael Castro, MD FACP, Project Coromec Principal Investigator. "Actions that could be taken with such reporting of information enables identification of hotspots of suspected new epidemic clusters by patterns of self-reported illness and perceived exposure, capture, and utilization of `drive-by' community testing that is done on an individual basis."

Project Coromec encourages subjects to enroll and help risk stratification by uniform capture of key individual baseline variables such as age, gender, race, occupation (direct healthcare worker/other), cardiovascular disease (especially heart failure), kidney disease (eGFR, on dialysis), diabetes mellitus, chronic lung disease, smoking history quantified in pack-years and current, dementia, baseline use of angiotensin converting enzyme inhibitors/angiotensin receptor II antagonists, mental health, and other illnesses towards battling the effects of the pandemic short and longer term.

"The four pillars of pandemic response include 'Contagion Control,' 'Early Home Treatment,' 'Hospitalization,' and 'Vaccination,'" said Peter A. McCullough, MD, FACC, MPH, in his widely quoted U.S. Senate testimony . Dr. McCullough, an eminent clinical consultant, is a Project Coromec study team member. "Early treatment and risk assessment are gaps that need to be addressed immediately at all stages of COVID19, including viral replication, cytokine storm, and microthrombosis. We urgently need early risk assessment and outpatient treatment with a multi-drug regimen to disrupt viral replication, thereby reducing the risk of progression to high-morbidity cytokine storm and microthrombosis, leading to high hospital admissions and mortality."

Project Coromec in Phase 2 plans to enroll COVID19-positive subjects to study the intervention group, comparing early treatment vs. placebo with primary end point of hospital admission assessment. This phase will study the treatment strategy for PCR (News - Alert)-positive COVID19 subjects in the registry who are at an early stage of the COVID19 disease process with early treatment drugs compared to placebo in reducing hospital admissions. Dr. McCullough has over 600 peer-reviewed publications, with multiple recent publications on COVID19 disease and early treatment guidance to prevent hospitalization and death.

Global public health providers, payers, pharma-life science researchers, academic research centers, and skilled nursing home care service providers can visit Project Coromec and contact the study team by email at [email protected] to participate in the study and upcoming COVID19 early treatment clinical studies and trials for patient engagement and population health. Funding for this solution was provided in part by Intel Corporation, as part of their goal to accelerate progress against global challenges. Intel is committed to accelerating access to technology that can combat the current pandemic and enable scientific discovery that better prepares our world for future crises.

About Aventyn, Inc.

@Aventyn is an innovative, award winning digital therapeutics company delivering clinical evidenced solutions for Personalized Chronic Care, Medical Imaging, Predictive Analytics, and Risk Assessment. Our standards-based, secure core to cloud connected solutions Lower Costs - Improve Quality - Better Outcomes for Health Providers, Insurers, and Pharma-life sciences Cogenetics for population health management. Aventyn connected clinical information processing solutions with proprietary health information security and integrated wireless bio-sensor capability enable continuity of care anytime, anywhere. and anyplace. Vitalbeat Integrated Chronic Disease Management patient personalized solutions are tailored for bedside, home, and remote monitoring. Aventyn offers patient personalized solutions with strategic provider and payer partners with locations at Aventyn AB Sweden, Aventyn UK Ltd, Aventyn India, and Aventyn Inc., USA.

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