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RECRUITING
NCT04678193

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Sponsor: Aventyn, Inc.

View on ClinicalTrials.gov

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

Official title: COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

27000

Start Date

2020-12-24

Completion Date

2026-06-30

Last Updated

2024-03-20

Healthy Volunteers

Yes

Conditions

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

Locations (3)

Multiple Locations

Phoenix, Arizona, United States

Multiple Locations

Bangalore, India

Multiple Locations

Stockholm, Sweden