COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy (COROMEC)

COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy

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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Coromec Registry with ECL-19

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

• Study Type: Observational
• Enrollment (Estimated): 27000

Contacts and Locations

• Study Contact: Name: Kris Vijay, MD; Phone Number: 2317942328; Email: coromec@aventyn.com
• Study Contact Backup: Name: Navin Govind; Phone Number: 2317942328; Email: coromec@aventyn.com

Study Locations

• India
  • Bangalore, India
    • Recruiting
    • Multiple locations
    • Contact: Kiran Balakrishna
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Multiple locations
    • Contact: Alexander Eriksson
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Recruiting
      • Multiple locations
      • Contact: Puja Chandler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Unselected patient population of COVID 19 positive infection

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID19 PCR positive test and negative or high risk asymptomatic; Patient population COVID-19 infection risk assessment real time epidemiology with 27000 subjects
COVID19 PCR positive test Stage 1 infection; Patient population of PCR positive COVID-19 Stage 1 infection in registry targeted for ECL-19 treatment for reduced hospitalization with 2700 subjects (10% ECL-19 and 20% Placebo)	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 Names: Glycocheck

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of post COVID-19 complications and predictors of hospitalization	Measure COVID-19 infection risk score based on PCR Positive Test	1 Day
Health symptom score	Measure COVID-19 infection risk score based on health symptoms	1 Day
Vital signs SpO2 score	Measure COVID-19 infection high risk score based on vital signs SpO2 <94%	1 Day
Vital signs BMI score of 40 kg/m2	Measure COVID-19 infection high risk score based on Height 0.15 meters and Weight of 122 Kgs	1 Day
Chronic Illness score	Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM	1 Day
Mental health assessment high score >11 on PHQ9 Depression score	Measure COVID-19 infection risk score based on mental health assessment for Depression	1 Day
Mental health assessment high score >11 on GAD 7 Anxiety score	Measure COVID-19 infection risk score based on mental health assessment for Anxiety	1 Day
Evaluate a treatment strategy with ECL-19	Measure hospital admissions in PCR positive COVID 19 subjects within 48 hours who are in Stage I of the disease process	1 Day

Collaborators and Investigators

• Sponsor: Aventyn, Inc.
• Collaborators: Karolinska Institutet; Intel Corporation; Abrazo Health Network; ASU College of Health Solutions
• Investigators: Principal Investigator: Hans A Vink, PhD, Maastricht University; Principal Investigator: Michael Castro, MD, Abrazo Health Network; Study Chair: Kris Vijay, MD, Abrazo Health Network

Publications and helpful links

General Publications

• Rovas A, Lukasz AH, Vink H, Urban M, Sackarnd J, Pavenstadt H, Kumpers P. Bedside analysis of the sublingual microvascular glycocalyx in the emergency room and intensive care unit - the GlycoNurse study. Scand J Trauma Resusc Emerg Med. 2018 Feb 14;26(1):16. doi: 10.1186/s13049-018-0483-4.
• Weissgerber TL, Garcia-Valencia O, Milic NM, Codsi E, Cubro H, Nath MC, White WM, Nath KA, Garovic VD. Early Onset Preeclampsia Is Associated With Glycocalyx Degradation and Reduced Microvascular Perfusion. J Am Heart Assoc. 2019 Feb 19;8(4):e010647. doi: 10.1161/JAHA.118.010647.
• Rovas A, Seidel LM, Vink H, Pohlkotter T, Pavenstadt H, Ertmer C, Hessler M, Kumpers P. Association of sublingual microcirculation parameters and endothelial glycocalyx dimensions in resuscitated sepsis. Crit Care. 2019 Jul 24;23(1):260. doi: 10.1186/s13054-019-2542-2.

Helpful Links

• Utility of Remote Monitoring Using a Mobile Phone in Patients with Heart Failure: the REMOTE-HF-1 Study

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CORAVT 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No