Official Title
COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
Brief Summary

Researchers are creating real-time epidemiology registry to evaluate the efficacy ofCOVID-19 subject risk assessment scores based on recording of symptoms, biomarkers,chronic illness and mental health assessments with digital technology using wearables andmobile app tools. Researchers aim to study in Phase 1, epidemiological variations inCOVID-19 presentation in both PCR positive and negative subjects in the registry.Assessment of variables, predictive modeling of variables that impact severity ofCOVID-19 positive and negative subjects and assessment of predictors for post COVID-19complications. In Phase 2, 2700 subjects with COVID-19 positive test will be studied inthe intervention group comparing ECL-19 vs placebo with primary end point of hospitaladmission assessment. Treatment strategy for PCR positive COVID-19 subjects in theregistry who are in Stage I of the disease process with ECL-19 drug compared to placeboin reducing hospital admissions

Detailed Description

Investigators aim is to create a real time COVID-19 Coromec epidemiology registry to
assess the feasibility of monitoring subject infection progress using Vitalbeat digital
therapeutics monitoring platform for remote patient monitoring and integrated chronic
disease management with mobile app, AI-bot, IoT wearables and cloud computing algorithms
developed by health technology company Aventyn, Inc., in collaboration with Intel Corp.,
clinicians and scientists from Baylor Heart, Abrazo Health, Karolinska Institute, Dignity
Health. Coromec registry is a real time epidemiology solution deploying Vitalbeat for
pandemic public health stakeholders to enable immediate reporting, assess subject risk
prediction for COVID-19 avoiding hospitalization.

The digital health technology aims to assess predictors of risk and predictors of
preventing COVID-19, assess what preventive strategies are being used and the efficacy of
treatment strategies for avoiding hospitalization. The platform launched globally and is
available on the public internet at www.coromec.org

Users can self-report symptoms, mental health assessment, chronic illness status and
vital sign measures on a daily basis for risk assessment and preventive treatment with a
variety of digital tools by downloading Coromec mobile app, access interactive chatbots
and the Coromec real time epidemiology website Researchers aim to study ECL-19 as a drug
treatment in stabilizing the endothelium as the first line of approach in COVID 19
positive subjects that may quickly restore their glycocalyx and endothelium thus avoiding
hospitalizations and progression of disease with ECL-19

A validated approach would enable vulnerable subjects and communities access to pandemic
care. Registry data can assist public health scientists in further studies and enable
global registries in future pandemic emergencies to help better understand use of digital
tools, intelligent algorithms and predict risk outcomes with targeted novel treatment
strategies

Recruiting
COVID19

Drug: Coromec Registry with ECL-19

Glycocheck to assess Microvascular Score will be used on all patients. An algorithm-based
identification of symptoms and objective evidence using care coordination and remote
sensor driven technology
Other Name: Glycocheck

Eligibility Criteria

Inclusion Criteria:

- COVID-19 PCR positive

- COVID-19 PCR negative

- COVID-19 PCR pending

- COVID-19 high risk score

Exclusion Criteria:

- Subjects unwilling to participate in the study before, during or after consent

- Patients considered unreliable by the investigator concerning the requirements for
follow-up visits.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
India
Sweden
United States
Locations

Multiple Locations
Phoenix, Arizona, United States

Multiple Locations
Bangalore, India

Multiple Locations
Stockholm, Sweden

Contacts

Kris Vijay, MD
2317942328
coromec@aventyn.com

Navin Govind
2317942328
coromec@aventyn.com

Aventyn, Inc.
NCT Number
MeSH Terms
COVID-19