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

NCT04714125 | Unknown

• 1 other identifier: FMDCOVID
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV Infection

Keywords

endothelial function; flow-mediated dilation; vascular function; carotid intima-media thickness

Outcome Measures

Primary Outcomes (1)

• Composite outcome

  A composite outcome including ICU admission, intubation and all-cause mortality

  Up to hospital discharge, an average of 4 weeks

Secondary Outcomes (4)

• All-cause mortality

  Up to hospital discharge, an average of 4 weeks

• ICU admission

  Up to hospital discharge, an average of 4 weeks

• Intubation

  Up to hospital discharge, an average of 4 weeks

• Cardiovascular complications

  Up to hospital discharge, an average of 4 weeks

Study Arms (1)

Patients with COVID-19

Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female adults with SARS-CoV-2 and recently admitted (≤ 72 hours) to the General Hospital of the Faculty of Medicine of the University of Sao Paulo.

You may qualify if:

• Patients diagnosed with SARS-CoV-2
• Recently admitted to the hospital (≤ 72 hours)
• Not yet proceeded to ICU care

You may not qualify if:

• Patients transferred from other hospitals
• Participants in delirium state
• Participants with a recent history of endotracheal intubation

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

São Paulo, 05403-010, Brazil

RECRUITING

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Tiago Peçanha, PhD

CONTACT

11948243542; tiagopecanha@usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: June 19, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

BR (1)