Covid19COROMECNCT04678193
COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
An observational study of Covid19, run by Aventyn, Inc. at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Coromec Registry with ECL-19
- How many people
- 27,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 Dec 2020to 30 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unselected patient population of COVID 19 positive infection
Who may be able to join
- COVID-19 PCR positive
- COVID-19 PCR negative
- COVID-19 PCR pending
- COVID-19 high risk score
Who cannot join
- 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 locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
Multiple Locations
Phoenix, Arizona, 85016
Puja Chandler
India1 site, 1 recruiting
- Recruiting
Multiple Locations
Bangalore
Kiran Balakrishna
Sweden1 site, 1 recruiting
- Recruiting
Multiple Locations
Stockholm
Alexander Eriksson
About this study
Official title: COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
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
Read the 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
- Being tested
- Coromec Registry with ECL-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coromec Registry with ECL-19Drug
Also called Glycocheck
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Coromec Registry with ECL-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of post COVID-19 complications and predictors of hospitalization
Measure COVID-19 infection risk score based on PCR Positive Test
Measured: 1 Day
Health symptom score
Measure COVID-19 infection risk score based on health symptoms
Measured: 1 Day
Vital signs SpO2 score
Measure COVID-19 infection high risk score based on vital signs SpO2 <94%
Measured: 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
Measured: 1 Day
Chronic Illness score
Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM
Measured: 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
Measured: 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
Measured: 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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start24 Dec 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 27,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Aventyn, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intel Corporation, Abrazo Health Network, Karolinska Institutet, ASU College of Health Solutions
- Responsible party
- Sponsor
- Investigators
- Hans A Vink, PhD, Principal investigator, Maastricht UniversityMichael Castro, MD, Principal investigator, Abrazo Health NetworkKris Vijay, MD, Study chair, Abrazo Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678193
- Sponsor's protocol ID
- CORAVT 001
- Acronym
- COROMEC
- Status last verified
- Mar 2024
- First submitted
- 6 Nov 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29444696Weissgerber 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.
PubMed 30764695Rovas 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.
PubMed 31340868
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
- ClinicalTrials.gov ID
- NCT04678193
- Acronym / sponsor ID
- COROMEC / CORAVT 001
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27,000 participants (estimated)
- Lead sponsor
- Aventyn, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Intel Corporation, Abrazo Health Network, Karolinska Institutet, ASU College of Health Solutions
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Coromec Registry with ECL-19Patient 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected patient population of COVID 19 positive infection
Key inclusion criteria (4 listed)
- COVID-19 PCR positive
- COVID-19 PCR negative
- COVID-19 PCR pending
- COVID-19 high risk score
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coromec Registry with ECL-19Also: GlycocheckGlycocheck 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 | Drug | COVID19 PCR positive test Stage 1 infection |
Primary outcome
Predictors of post COVID-19 complications and predictors of hospitalization
Time frame: 1 Day
Measure COVID-19 infection risk score based on PCR Positive Test
Health symptom score
Time frame: 1 Day
Measure COVID-19 infection risk score based on health symptoms
Vital signs SpO2 score
Time frame: 1 Day
Measure COVID-19 infection high risk score based on vital signs SpO2 <94%
Vital signs BMI score of 40 kg/m2
Time frame: 1 Day
Measure COVID-19 infection high risk score based on Height 0.15 meters and Weight of 122 Kgs
Chronic Illness score
Time frame: 1 Day
Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM
Mental health assessment high score >11 on PHQ9 Depression score
Time frame: 1 Day
Measure COVID-19 infection risk score based on mental health assessment for Depression
Mental health assessment high score >11 on GAD 7 Anxiety score
Time frame: 1 Day
Measure COVID-19 infection risk score based on mental health assessment for Anxiety
Evaluate a treatment strategy with ECL-19
Time frame: 1 Day
Measure hospital admissions in PCR positive COVID 19 subjects within 48 hours who are in Stage I of the disease process
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 29444696Rovas 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.
- Background: PubMed 30764695Weissgerber 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.
- Background: PubMed 31340868Rovas 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.
- Utility of Remote Monitoring Using a Mobile Phone in Patients with Heart Failure: the REMOTE-HF-1 StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans A Vink, PhD principal investigator
Maastricht University
Michael Castro, MD principal investigator
Abrazo Health Network
Kris Vijay, MD study chair
Abrazo Health Network
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Aventyn, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, India, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kris Vijay, MD (2317942328, coromec@aventyn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of post COVID-19 complications and predictors of hospitalization (time frame: 1 Day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.