COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Aventyn, Inc.
Study ID
NCT04678193
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Coromec Registry with ECL-19 — DRUG
    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

Study Details

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

Key Dates

Start date
Dec 24, 2020
Status verified
Mar 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
27,000 participants (estimated)

Arms

  • Arm: COVID19 PCR positive test and negative or high risk asymptomatic
    Patient population COVID-19 infection risk assessment real time epidemiology with 27000 subjects
  • Arm: 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)

Primary Outcome Measure

Predictors of post COVID-19 complications and predictors of hospitalization [ Time Frame: 1 Day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Multiple LocationsPhoenixArizona85016
Puja Chandler

Find similar trials in Phoenix, AZ

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Multiple Locations· Phoenix, AZ

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