Covid19 Clinical Trial
— COROMECOfficial title:
COVID-19 Risk Assessment Hospitalization Outcomes Epidemiology Efficacy
NCT number | NCT04678193 |
Other study ID # | CORAVT 001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 24, 2020 |
Est. completion date | June 30, 2026 |
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
Status | Recruiting |
Enrollment | 27000 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Multiple Locations | Bangalore | |
Sweden | Multiple Locations | Stockholm | |
United States | Multiple Locations | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Aventyn, Inc. | Abrazo Health Network, ASU College of Health Solutions, Intel Corporation, Karolinska Institutet |
United States, India, Sweden,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Predictors of post COVID-19 complications and predictors of hospitalization | Measure COVID-19 infection risk score based on PCR Positive Test | 1 Day | |
Primary | Health symptom score | Measure COVID-19 infection risk score based on health symptoms | 1 Day | |
Primary | Vital signs SpO2 score | Measure COVID-19 infection high risk score based on vital signs SpO2 <94% | 1 Day | |
Primary | 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 | |
Primary | Chronic Illness score | Measure COVID-19 infection high risk score based on chronic illness response; Yes on uncontrolled Asthma, COPD, Hypertension, T2DM | 1 Day | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |