COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

Status unconfirmed

Conditions studied: Covid19

In brief

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 facts

Study ID

NCT04678193

Run by

Aventyn, Inc.

People needed

27000

Starts

2020-12-24

Expected to finish

2026-06-30

Last updated by the study team

2024-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• COVID-19 PCR positive
• COVID-19 PCR negative
• COVID-19 PCR pending
• COVID-19 high risk score

You may not qualify if…

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

Where it is running

• Multiple Locations — Phoenix, Arizona, United States (enrolling)
• Multiple Locations — Bangalore, India (enrolling)
• Multiple Locations — Stockholm, Sweden (enrolling)

Full record on ClinicalTrials.gov

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