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

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ClinicalTrials.gov Identifier: NCT04678193
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : May 26, 2021
Sponsor:
Collaborators:
Intel Corporation
Abrazo Health Network
Karolinska Institutet
ASU College of Health Solutions
Information provided by (Responsible Party):
Aventyn, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment
Covid19 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 27000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
Actual Study Start Date : December 24, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: Glycocheck




Primary Outcome Measures :
  1. Predictors of post COVID-19 complications and predictors of hospitalization [ Time Frame: 1 Day ]
    Measure COVID-19 infection risk score based on PCR Positive Test

  2. Health symptom score [ Time Frame: 1 Day ]
    Measure COVID-19 infection risk score based on health symptoms

  3. Vital signs SpO2 score [ Time Frame: 1 Day ]
    Measure COVID-19 infection high risk score based on vital signs SpO2 <94%

  4. Vital signs BMI score of 40 kg/m2 [ Time Frame: 1 Day ]
    Measure COVID-19 infection high risk score based on Height 0.15 meters and Weight of 122 Kgs

  5. Chronic Illness score [ Time Frame: 1 Day ]
    Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM

  6. Mental health assessment high score >11 on PHQ9 Depression score [ Time Frame: 1 Day ]
    Measure COVID-19 infection risk score based on mental health assessment for Depression

  7. Mental health assessment high score >11 on GAD 7 Anxiety score [ Time Frame: 1 Day ]
    Measure COVID-19 infection risk score based on mental health assessment for Anxiety

  8. Evaluate a treatment strategy with ECL-19 [ Time Frame: 1 Day ]
    Measure hospital admissions in PCR positive COVID 19 subjects within 48 hours who are in Stage I of the disease process



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Unselected patient population of COVID 19 positive infection
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04678193


Contacts
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Contact: Kris Vijay, MD 2317942328 coromec@aventyn.com
Contact: Navin Govind 2317942328 coromec@aventyn.com

Locations
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United States, Arizona
Multiple Locations Recruiting
Phoenix, Arizona, United States, 85016
Contact: Puja Chandler         
India
Multiple Locations Recruiting
Bangalore, India
Contact: Kiran Balakrishna         
Sweden
Multiple Locations Recruiting
Stockholm, Sweden
Contact: Alexander Eriksson         
Sponsors and Collaborators
Aventyn, Inc.
Intel Corporation
Abrazo Health Network
Karolinska Institutet
ASU College of Health Solutions
Investigators
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Study Director: Peter A McCullough, MD Baylor Heart and Vascular Institute
Principal Investigator: Michael Castro, MD Abrazo Health Network
Study Chair: Kris Vijay, MD Abrazo Health Network
Additional Information:
Publications:
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Responsible Party: Aventyn, Inc.
ClinicalTrials.gov Identifier: NCT04678193    
Other Study ID Numbers: CORAVT 001
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases