COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• COVID-19 PCR positive

• COVID-19 PCR negative

• COVID-19 PCR pending

• COVID-19 high risk score

Locations
United States
Arizona
Multiple Locations
RECRUITING
Phoenix
Other Locations
India
Multiple Locations
RECRUITING
Bangalore
Sweden
Multiple Locations
RECRUITING
Stockholm
Contact Information
Primary
Kris Vijay, MD
coromec@aventyn.com
2317942328
Backup
Navin Govind
coromec@aventyn.com
2317942328
Time Frame
Start Date: 2020-12-24
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 27000
Treatments
COVID19 PCR positive test and negative or high risk asymptomatic
Patient population COVID-19 infection risk assessment real time epidemiology with 27000 subjects
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)
Related Therapeutic Areas
Sponsors
Collaborators: Karolinska Institutet, Intel Corporation, Abrazo Health Network, ASU College of Health Solutions
Leads: Aventyn, Inc.

This content was sourced from clinicaltrials.gov