Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19. The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death. Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.

Detailed Description
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This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization. The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints. The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.

Official Title
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Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study

Conditions
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Covid19, SARS-CoV Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with SARS-CoV-2 Recently admitted to the hospital (≤ 72 hours) Not yet proceeded to ICU care Exclusion Criteria: Patients transferred from other hospitals Participants in delirium state Participants with a recent history of endotracheal intubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COVID-19<br>Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome | A composite outcome including ICU admission, intubation and all-cause mortality | Up to hospital discharge, an average of 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause mortality rate along the study | Up to hospital discharge, an average of 4 weeks | 
| ICU admission | Admission to the ICU along the study | Up to hospital discharge, an average of 4 weeks | 
| Intubation | Necessity of intubation along the study | Up to hospital discharge, an average of 4 weeks | 
| Cardiovascular complications | Cardiovascular complications, such as arterial, deep venous or pulmonary embolism, acute myocardial infarction, stroke, cardiac arrest, atrial fibrillation and acute kidney injury | Up to hospital discharge, an average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endothelial function, flow-mediated dilation, vascular function, carotid intima-media thickness