About this trial
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
This trial accepts healthy volunteersQualifiers
COVID-19 PCR positive
COVID-19 PCR negative
COVID-19 PCR pending
COVID-19 high risk score
Disqualifiers
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.
Trial population
Unselected patient population of COVID 19 positive infection
Trial design
Cohort
Other
Treatments tested in this trial
Coromec Registry with ECL-19
DrugGlycocheck to assess Microvascular Score will be used on all patients. An algorithm-based identification of symptoms and objective evidence using care coordination and remote sensor driven technology
Treatment groups
Trial outcomes
Primary outcomes
Predictors of post COVID-19 complications and predictors of hospitalization
Measure COVID-19 infection risk score based on PCR Positive Test
Health symptom score
Measure COVID-19 infection risk score based on health symptoms
Vital signs SpO2 score
Measure COVID-19 infection high risk score based on vital signs SpO2 \<94%
Vital signs BMI score of 40 kg/m2
Measure COVID-19 infection high risk score based on Height 0.15 meters and Weight of 122 Kgs
Sponsors and contacts
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Aventyn, Inc.
Lead sponsor
Intel Corporation
Collaborator
Abrazo Health Network
Collaborator
Karolinska Institutet
Collaborator
ASU College of Health Solutions
Collaborator