Endothelial Function and COVID-19

NCT04525443 | Completed DMC

• 1 other identifier: 20/451
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 2

Brief Summary

The present study aims to investigate the endothelial vasodilator function in patients with COVID-19

Conditions

COVID-19

Keywords

Endothelial function; Endothelial cells; Blood vessels

Outcome Measures

Primary Outcomes (1)

• Reactive hyperemia index (RHI)

  RHI derived from peripheral arterial tonometry with EndoPat system (Itamar)

  Baseline

Secondary Outcomes (2)

• Percentage of COVID-19 patients with impaired endothelial vasodilator function.

  Up to 3 months

• Percentage of non-COVID-19 patients with impaired endothelial vasodilator function.

  Baseline

Other Outcomes (1)

• Percentage variation of RHI during the evolutionary course of COVID-19.

  At baseline and 1-3 months after COVID-19 resolution

Study Arms (3)

Patients with active SARS-CoV-2 infection.

Patients admitted for COVID-19 at Hospital Clínico San Carlos with positive SARS-CoV-2 polymerase chain reaction (PCR).

Patients with past, not active, SARS-CoV-2 infection.

Patients with past infection (not active), demonstrated by serology and PCR.

People without concurrent or past SARS-CoV-2 infection

Health personnel from the Cardiology Service of Hospital Clínico San Carlos who demonstrate by serology that they have not had SARS-CoV-2 infection.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is made up of three group of patients: * Study group No. 1: patients with active SARS-CoV-2 infection. * Study group No. 2: patients with past, not active, SARS-CoV-2 infection. * Control group: People without concurrent or past SARS-CoV-2 infection. Group No. 1 will include patients admitted for COVID-19 at Hospital Clínico San Carlos with positive SARS-CoV-2 PCR; group 2 will include patients with past infection demonstrated by serology and PCR, and will be constituted by either health personnel from Hospital Clínico San Carlos who have passed the disease, or patients who have been discharged from the hospital; and the control group will include health personnel from the Cardiology Service of Hospital Clínico San Carlos who demonstrate by serology that they have not had SARS-CoV-2 infection.

You may qualify if:

• Study group No. 1: age ≥ 18 years; COVID-19 confirmed with positive PCR. Availability of informed consent.
• Study group No. 2: age ≥ 18 years; Past SARS-CoV-2 infection demonstrated by PCR and serology.
• Control group: age ≥ 18 years; absence of concurrent or previous SARS-CoV2 infection demonstrated by serology, and absence of acute or chronic diseases related to endothelial dysfunction, mainly acute or chronic infectious or inflammatory processes and known peripheral vascular disease.

You may not qualify if:

• Impossibility of performing the endothelial function test.
• Recent puncture of the radial artery (\<15 days).
• Hemodynamic instability.
• Unavailability of signed informed consent.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: June 3, 2020
• Primary Completion: November 11, 2020
• Study Completion: February 11, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

US (1); ES (1)