RECRUITING

COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-12-24
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04678193

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * COVID-19 PCR positive
  2. * COVID-19 PCR negative
  3. * COVID-19 PCR pending
  4. * COVID-19 high risk score
  1. * Subjects unwilling to participate in the study before, during or after consent
  2. * Patients considered unreliable by the investigator concerning the requirements for follow-up visits.

Contacts and Locations

Study Contact

Kris Vijay, MD
CONTACT
2317942328
coromec@aventyn.com
Navin Govind
CONTACT
2317942328
coromec@aventyn.com

Principal Investigator

Hans A Vink, PhD
PRINCIPAL_INVESTIGATOR
Maastricht University
Michael Castro, MD
PRINCIPAL_INVESTIGATOR
Abrazo Health Network
Kris Vijay, MD
STUDY_CHAIR
Abrazo Health Network

Study Locations (Sites)

Multiple Locations
Phoenix, Arizona, 85016
United States

Collaborators and Investigators

Sponsor: Aventyn, Inc.

  • Hans A Vink, PhD, PRINCIPAL_INVESTIGATOR, Maastricht University
  • Michael Castro, MD, PRINCIPAL_INVESTIGATOR, Abrazo Health Network
  • Kris Vijay, MD, STUDY_CHAIR, Abrazo Health Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-24
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-12-24
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Covid19