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

• Conditions: SARS-CoV Infection; Covid19

• Registration Number: NCT04714125
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-06-19
• Status Verified: 2021-01
• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Primary Completion: 2021-02-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome	Up to hospital discharge, an average of 4 weeks	A composite outcome including ICU admission, intubation and all-cause mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP; 🇧🇷 Sao Paulo, Brazil