COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy

NCT04678193 | Recruiting DMC

• 1 other identifier: CORAVT 001
• Study Type: observational
• Target: 27,000
• Locations: 3 countries
• Sites: 3

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

• Predictors of post COVID-19 complications and predictors of hospitalization

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

  1 Day

• Health symptom score

  Measure COVID-19 infection risk score based on health symptoms

  1 Day

• Vital signs SpO2 score

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

  1 Day

• 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

  1 Day

• Chronic Illness score

  Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM

  1 Day

• Mental health assessment high score >11 on PHQ9 Depression score

  Measure COVID-19 infection risk score based on mental health assessment for Depression

  1 Day

• Mental health assessment high score >11 on GAD 7 Anxiety score

  Measure COVID-19 infection risk score based on mental health assessment for Anxiety

  1 Day

• Evaluate a treatment strategy with ECL-19

  Measure hospital admissions in PCR positive COVID 19 subjects within 48 hours who are in Stage I of the disease process

  1 Day

Study Arms (2)

COVID19 PCR positive test and negative or high risk asymptomatic

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

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)

Drug: Coromec Registry with ECL-19

Interventions

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

Also known as: Glycocheck

COVID19 PCR positive test Stage 1 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected patient population of COVID 19 positive infection

You may qualify if:

• COVID-19 PCR positive
• COVID-19 PCR negative
• COVID-19 PCR pending
• COVID-19 high risk score

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aventyn, Inc.: lead
• Intel Corporation: collaborator
• Abrazo Health Network: collaborator
• Karolinska Institutet: collaborator
• ASU College of Health Solutions: collaborator

Study Sites (3)

Multiple Locations

Phoenix, Arizona, 85016, United States

RECRUITING

Multiple Locations

Bangalore, India

RECRUITING

Multiple Locations

Stockholm, Sweden

RECRUITING

Related Publications (3)

• 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.

  PMID: 29444696 BACKGROUND

• 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.

  PMID: 30764695 BACKGROUND

• 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.

  PMID: 31340868 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hans A Vink, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Michael Castro, MD

  Abrazo Health Network

  PRINCIPAL INVESTIGATOR

• Kris Vijay, MD

  Abrazo Health Network

  STUDY CHAIR

Central Study Contacts

Kris Vijay, MD

CONTACT

2317942328; coromec@aventyn.com

Navin Govind

CONTACT

2317942328; coromec@aventyn.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: December 21, 2020
• Study Start: December 24, 2020
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); US (1); IN (1)