COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * COVID-19 PCR positive * COVID-19 PCR negative * COVID-19 PCR pending * COVID-19 high risk score Exclusion Criteria: * 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.