Clinical trial NCT04678193: COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
Official title: COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Aventyn, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Intel Corporation
name: Abrazo Health Network
name: Karolinska Institutet
name: ASU College of Health Solutions
First posted: 2020-12-21
Enrollment: 27000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unselected patient population of COVID 19 positive infection

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

Detailed description: Investigators aim is to create a real time COVID-19 Coromec epidemiology registry to assess the feasibility of monitoring subject infection progress using Vitalbeat digital therapeutics monitoring platform for remote patient monitoring and integrated chronic disease management with mobile app, AI-bot, IoT wearables and cloud computing algorithms developed by health technology company Aventyn, Inc., in collaboration with Intel Corp., clinicians and scientists from Baylor Heart, Abrazo Health, Karolinska Institute, Dignity Health. Coromec registry is a real time epidemiology solution deploying Vitalbeat for pandemic public health stakeholders to enable immediate reporting, assess subject risk prediction for COVID-19 avoiding hospitalization.

The digital health technology aims to assess predictors of risk and predictors of preventing COVID-19, assess what preventive strategies are being used and the efficacy of treatment strategies for avoiding hospitalization. The platform launched globally and is available on the public internet at www.coromec.org

Users can self-report symptoms, mental health assessment, chronic illness status and vital sign measures on a daily basis for risk assessment and preventive treatment with a variety of digital tools by downloading Coromec mobile app, access interactive chatbots and the Coromec real time epidemiology website Researchers aim to study ECL-19 as a drug treatment in stabilizing the endothelium as the first line of approach in COVID 19 positive subjects that may quickly restore their glycocalyx and endothelium thus avoiding hospitalizations and progression of disease with ECL-19

A validated approach would enable vulnerable subjects and communities access to pandemic care. Registry data can assist public health scientists in further studies and enable global registries in future pandemic emergencies to help better understand use of digital tools, intelligent algorithms and predict risk outcomes with targeted novel treatment strategies

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.

Primary outcomes:
measure: Predictors of post COVID-19 complications and predictors of hospitalization
timeFrame: 1 Day
measure: Health symptom score
timeFrame: 1 Day
measure: Vital signs SpO2 score
timeFrame: 1 Day
measure: Vital signs BMI score of 40 kg/m2
timeFrame: 1 Day
measure: Chronic Illness score
timeFrame: 1 Day
measure: Mental health assessment high score >11 on PHQ9 Depression score
timeFrame: 1 Day
measure: Mental health assessment high score >11 on GAD 7 Anxiety score
timeFrame: 1 Day
measure: Evaluate a treatment strategy with ECL-19
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Multiple Locations
state: Arizona
city: Bangalore
country: India
facility: Multiple Locations
city: Stockholm
country: Sweden
facility: Multiple Locations
Study officials:
affiliation: Maastricht University
name: Hans A Vink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abrazo Health Network
name: Michael Castro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abrazo Health Network
name: Kris Vijay, MD
role: STUDY_CHAIR
References:
citation: Rovas A, Lukasz AH, Vink H, Urban M, Sackarnd J, Pavenstadt H, Kumpers P. Bedside analysis of the sublingual microvascular glycocalyx in the emergency room and intensive care unit - the GlycoNurse study. Scand J Trauma Resusc Emerg Med. 2018 Feb 14;26(1):16. doi: 10.1186/s13049-018-0483-4.
citation: Weissgerber TL, Garcia-Valencia O, Milic NM, Codsi E, Cubro H, Nath MC, White WM, Nath KA, Garovic VD. Early Onset Preeclampsia Is Associated With Glycocalyx Degradation and Reduced Microvascular Perfusion. J Am Heart Assoc. 2019 Feb 19;8(4):e010647. doi: 10.1161/JAHA.118.010647.
citation: Rovas A, Seidel LM, Vink H, Pohlkotter T, Pavenstadt H, Ertmer C, Hessler M, Kumpers P. Association of sublingual microcirculation parameters and endothelial glycocalyx dimensions in resuscitated sepsis. Crit Care. 2019 Jul 24;23(1):260. doi: 10.1186/s13054-019-2542-2.