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COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

NCT04678193 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 27000

Last updated 2024-03-20

No results posted yet for this study

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

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • Intel Corporation

    collaborator INDUSTRY

  • Abrazo Health Network

    collaborator UNKNOWN

  • Karolinska Institutet

    collaborator OTHER

  • ASU College of Health Solutions

    collaborator UNKNOWN

  • Aventyn, Inc.

    lead INDUSTRY

Principal Investigators

  • Hans A Vink, PhD · Maastricht University

  • Michael Castro, MD · Abrazo Health Network

  • Kris Vijay, MD · Abrazo Health Network

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-24
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • United States
  • India
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678193 on ClinicalTrials.gov