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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04678193
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : January 12, 2021
Sponsor:
Collaborators:
Intel Corporation
Abrazo Health Network
Karolinska Institutet
ASU College of Health Solutions
Information provided by (Responsible Party):
Aventyn, Inc.

Tracking Information
First Submitted Date November 6, 2020
First Posted Date December 21, 2020
Last Update Posted Date January 12, 2021
Actual Study Start Date December 24, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2020)
  • 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
  • Health symptom score [ Time Frame: 1 Day ]
    Measure COVID-19 infection risk score based on health symptoms
  • Vital signs SpO2 score [ Time Frame: 1 Day ]
    Measure COVID-19 infection high risk score based on vital signs SpO2 <94%
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
Official Title COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
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
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Unselected patient population of COVID 19 positive infection
Condition Covid19
Intervention 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
Study Groups/Cohorts
  • 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)
    Intervention: Drug: Coromec Registry with ECL-19
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: December 18, 2020)
27000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04678193
Other Study ID Numbers CORAVT 001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Aventyn, Inc.
Study Sponsor Aventyn, Inc.
Collaborators
  • Intel Corporation
  • Abrazo Health Network
  • Karolinska Institutet
  • ASU College of Health Solutions
Investigators
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
PRS Account Aventyn, Inc.
Verification Date January 2021