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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04714125
• Other study ID #: FMDCOVID
• Status: Recruiting
• Start date: June 19, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2021
• Source: University of Sao Paulo General Hospital
• Contact: Tiago Peçanha, PhD
• Phone: 11948243542
• Email: tiagopecanha[@]usp.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 1, 2022
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Infection
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome	A composite outcome including ICU admission, intubation and all-cause mortality	Up to hospital discharge, an average of 4 weeks
Secondary	All-cause mortality	All-cause mortality rate along the study	Up to hospital discharge, an average of 4 weeks
Secondary	ICU admission	Admission to the ICU along the study	Up to hospital discharge, an average of 4 weeks
Secondary	Intubation	Necessity of intubation along the study	Up to hospital discharge, an average of 4 weeks
Secondary	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