COVID-19 Risk Assessment and Epidemiology Study

This observational study, called Coromec, is looking at how COVID-19 affects people and what factors might predict who gets very sick or needs to go to the hospital. Researchers are using a registry (a collection of health information) and digital tools like wearables and a mobile app to track symptoms, vital signs (like SpO2, which measures oxygen in your blood), and other health information. They are also using a tool called Glycocheck to assess microvascular score (a measure of small blood vessel health). The goal is to understand how COVID-19 presents in different people and to find ways to predict and prevent severe outcomes. This study is open to adults aged 18 and older who have tested positive, negative, or are awaiting results for COVID-19, or who have a high-risk score for COVID-19. The study aims to enroll 27,000 people, but its current status is unclear.

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It aims to enroll 27,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Predictors of post COVID-19 complications and hospitalization, health symptom scores, and vital signs (SpO2) are measured at 1 day.

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NCT04678193

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

UNKNOWN
Not specifiedAges 18+Observational
Aventyn, Inc.
~27,000 participants
Updated 2024-03-20 on ClinicalTrials.gov
What's tested:Coromec Registry with ECL-19

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Predictors of post COVID-19 complications and predictors of hospitalization
Measured over 1 Day
+7 more outcomes measured
Covid19
3 sites across 3 states
Arizona1
India1
Sweden1
  • Hans A Vink, PhD · PRINCIPAL_INVESTIGATOR · Maastricht University
  • Michael Castro, MD · PRINCIPAL_INVESTIGATOR · Abrazo Health Network
  • Kris Vijay, MD · STUDY_CHAIR · Abrazo Health Network

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Eligibility criteria

Inclusion

COVID-19 PCR positive
COVID-19 PCR negative
COVID-19 PCR pending
COVID-19 high risk score

Exclusion

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.
  • Predictors of post COVID-19 complications and predictors of hospitalization1 Day

    Measure COVID-19 infection risk score based on PCR Positive Test

  • Health symptom score1 Day

    Measure COVID-19 infection risk score based on health symptoms

  • Vital signs SpO2 score1 Day

    Measure COVID-19 infection high risk score based on vital signs SpO2 \<94%

  • Vital signs BMI score of 40 kg/m21 Day

    Measure COVID-19 infection high risk score based on Height 0.15 meters and Weight of 122 Kgs

  • Chronic Illness score1 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 score1 Day

    Measure COVID-19 infection risk score based on mental health assessment for Depression

  • Mental health assessment high score >11 on GAD 7 Anxiety score1 Day

    Measure COVID-19 infection risk score based on mental health assessment for Anxiety

  • Evaluate a treatment strategy with ECL-191 Day

    Measure hospital admissions in PCR positive COVID 19 subjects within 48 hours who are in Stage I of the disease process