COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

ConditionCovid19
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAventyn, Inc.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Coromec Registry with ECL-19

    Drug

    Glycocheck 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

27,000 Participants
are divided into 2 treatment groups
Group A: COVID19 PCR positive test and negative or high risk asymptomatic0 interventions
Group B: COVID19 PCR positive test Stage 1 infection1 intervention

Trial outcomes

Primary outcomes

1

Predictors of post COVID-19 complications and predictors of hospitalization

Measure COVID-19 infection risk score based on PCR Positive Test

Time frame
1 Day
2

Health symptom score

Measure COVID-19 infection risk score based on health symptoms

Time frame
1 Day
3

Vital signs SpO2 score

Measure COVID-19 infection high risk score based on vital signs SpO2 \<94%

Time frame
1 Day
4

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

Time frame
1 Day

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aventyn, Inc.

Lead sponsor

Intel Corporation

Collaborator

Abrazo Health Network

Collaborator

Karolinska Institutet

Collaborator

ASU College of Health Solutions

Collaborator