Bedside analysis of the sublingual microvascular glycocalyx in the emergency room and intensive care unit - the GlycoNurse study.
Alexandros Rovas, Alexander-Henrik Lukasz, Hans Vink...
https://pubmed.ncbi.nlm.nih.gov/29444696Actively Recruiting
Led by Aventyn, Inc. · Updated on 2024-03-20
27000
Participants Needed
3
Research Sites
52 weeks
Total Duration
A
Aventyn, Inc.
Lead Sponsor
I
Intel Corporation
Collaborating Sponsor
Researchers are developing a real-time epidemiology registry to evaluate COVID-19 risk assessment scores by recording symptoms, biomarkers, chronic illnesses, and mental health using digital tools like wearables and mobile apps. The study aims to explore variations in COVID-19 presentation among both PCR positive and negative individuals and identify factors predicting disease severity and post-COVID-19 complications. In Phase 2, 2,700 COVID-19 positive subjects will be studied to compare the effects of the drug ECL-19 against placebo on hospital admission rates. The study involves using the Coromec real-time epidemiology registry and the Vitalbeat digital therapeutics platform for remote patient monitoring, integrated with mobile apps, AI chatbots, IoT wearables, and cloud computing. Participants can self-report symptoms, mental health, chronic illness status, and vital signs daily. ECL-19 is being studied as a treatment to stabilize the endothelium in early-stage COVID-19 positive subjects, aiming to reduce hospitalizations. The registry supports public health by enabling immediate reporting and risk prediction. Participants will provide daily data through the Coromec app and website, including symptom scores, vital signs like oxygen saturation and BMI, chronic illness, and mental health assessments. Researchers will monitor these measures to evaluate predictors of hospitalization and post-COVID complications. The study also assesses the treatment strategy with ECL-19. Participation may involve follow-up visits, and the data collected will help improve pandemic care and guide future public health responses.
CONDITIONS
COVID-19 Risk Assessment for Hospitalization Outcomes and Epidemiology Efficacy
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Up to 1 year
Participants self-report symptoms, mental health assessments, chronic illness status, and vital signs daily using the Coromec mobile app and digital tools for real-time COVID-19 risk assessment and epidemiology monitoring.
Daily self-reporting via mobile app
Duration - Treatment duration as per protocol (not specified)
Participants with PCR positive Stage 1 COVID-19 infection receive ECL-19 treatment aimed at stabilizing the endothelium to prevent hospitalization and disease progression.
Treatment administered as part of the registry; assessment visits as scheduled per protocol
Total: 3 locations
1
Multiple Locations
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Multiple Locations
Bangalore, India
Actively Recruiting
3
Multiple Locations
Stockholm, Sweden
Actively Recruiting
K
Kris Vijay, MD
N
Navin Govind
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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