Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID04678193

COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy

Led by Aventyn, Inc. · Updated on 2024-03-20

27000

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

A

Aventyn, Inc.

Lead Sponsor

I

Intel Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing a real-time epidemiology registry to evaluate COVID-19 risk assessment scores by recording symptoms, biomarkers, chronic illnesses, and mental health using digital tools like wearables and mobile apps. The study aims to explore variations in COVID-19 presentation among both PCR positive and negative individuals and identify factors predicting disease severity and post-COVID-19 complications. In Phase 2, 2,700 COVID-19 positive subjects will be studied to compare the effects of the drug ECL-19 against placebo on hospital admission rates. The study involves using the Coromec real-time epidemiology registry and the Vitalbeat digital therapeutics platform for remote patient monitoring, integrated with mobile apps, AI chatbots, IoT wearables, and cloud computing. Participants can self-report symptoms, mental health, chronic illness status, and vital signs daily. ECL-19 is being studied as a treatment to stabilize the endothelium in early-stage COVID-19 positive subjects, aiming to reduce hospitalizations. The registry supports public health by enabling immediate reporting and risk prediction. Participants will provide daily data through the Coromec app and website, including symptom scores, vital signs like oxygen saturation and BMI, chronic illness, and mental health assessments. Researchers will monitor these measures to evaluate predictors of hospitalization and post-COVID complications. The study also assesses the treatment strategy with ECL-19. Participation may involve follow-up visits, and the data collected will help improve pandemic care and guide future public health responses.

CONDITIONS

Brief Title

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • COVID-19 PCR positive
  • COVID-19 PCR negative
  • COVID-19 PCR pending
  • COVID-19 high risk score
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Subjects unwilling to participate before, during, or after consent
  • Patients considered unreliable for follow-up visits by the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Monitoring

Duration - Up to 1 year

Participants self-report symptoms, mental health assessments, chronic illness status, and vital signs daily using the Coromec mobile app and digital tools for real-time COVID-19 risk assessment and epidemiology monitoring.

Daily self-reporting via mobile app

Treatment

Duration - Treatment duration as per protocol (not specified)

Participants with PCR positive Stage 1 COVID-19 infection receive ECL-19 treatment aimed at stabilizing the endothelium to prevent hospitalization and disease progression.

Treatment administered as part of the registry; assessment visits as scheduled per protocol

Trial Site Locations

Total: 3 locations

1

Multiple Locations

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Multiple Locations

Bangalore, India

Actively Recruiting

3

Multiple Locations

Stockholm, Sweden

Actively Recruiting

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Research Team

K

Kris Vijay, MD

N

Navin Govind

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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