COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

NCT ID: NCT04678193

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 27000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-24
• Study Completion Date: 2026-06-30

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

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

COVID19 PCR positive test and negative or high risk asymptomatic

Patient population COVID-19 infection risk assessment real time epidemiology with 27000 subjects

No interventions assigned to this group

COVID19 PCR positive test Stage 1 infection

Patient population of PCR positive COVID-19 Stage 1 infection in registry targeted for ECL-19 treatment for reduced hospitalization with 2700 subjects (10% ECL-19 and 20% Placebo)

Coromec Registry with ECL-19

Intervention Type: 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

Interventions

Coromec Registry with ECL-19

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

Intervention Type: DRUG

Other Intervention Names

Glycocheck

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intel Corporation

INDUSTRY

Sponsor Role: collaborator

Abrazo Health Network

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

ASU College of Health Solutions

UNKNOWN

Sponsor Role: collaborator

Aventyn, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans A Vink, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Michael Castro, MD

Role: PRINCIPAL_INVESTIGATOR

Abrazo Health Network

Kris Vijay, MD

Role: STUDY_CHAIR

Abrazo Health Network

Locations

Multiple Locations

Phoenix, Arizona, United States

Site Status: RECRUITING

Multiple Locations

Bangalore, , India

Site Status: RECRUITING

Multiple Locations

Stockholm, , Sweden

Site Status: RECRUITING

Countries

United States; India; Sweden

Central Contacts

Kris Vijay, MD

Role: CONTACT

coromec@aventyn.com

2317942328

Navin Govind

Role: CONTACT

coromec@aventyn.com

2317942328

Facility Contacts

Puja Chandler

Role: primary

Kiran Balakrishna

Role: primary

Alexander Eriksson

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 29444696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30764695 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31340868 (View on PubMed)

Other Identifiers

CORAVT 001

Identifier Type: -

Identifier Source: org_study_id