Endothelial Damage and Angiogenesis Biomarkers During COVID-19

Completed

• Conditions: Angiogenesis; Endothelial Dysfunction; Covid19; Cardiovascular Morbidity

• Registration Number: NCT04609332
• Lead Sponsor: University of Chile

Brief Summary

Severe SARS-CoV-2 disease is characterized by a progressive hypoxemic respiratory failure. Autopsies from these patients show severe endothelial damage with extensive vascular thrombosis, microangiopathy, and occlusion of alveolar capillaries and, finally, evidence of new vessel growth through intussusceptive angiogenesis.

This research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events.

Detailed Description

To study the presence of endothelial damage and angiogenic biomarkers with major cardiovascular events, the investigators will perform an observational study to evaluate plasma biomarkers concentrations in Covid-19 patients hospitalized in critical care units.

After ethical review board approval, the investigators will select 40 patients admitted to intensive care units (ICU). After patient written consent or if the participants are unable to consent, after a relative subrogated acceptance, the investigators will collect blood samples in the first 24 hrs and on the 10th day of hospitalization.

Venous blood samples are collected. After obtaining all samples, serum Syndecan-1, thrombomodulin, ANG-2, FGF basic, HGF, IL-8, PDGF-BB, TIMP-1, TIMP-2, TNFα y VEGF will be determined by a researcher blinded to the patient using commercially available Elisa kits. The concentration of each biomarker at each sample time will be compared. The investigators will observe clinical outcomes after one, 3, 6, and 12 months after the hospitalization.

The investigators found no previous data of this measurement in the COVID-19 scenario. In this observational study, the investigators select a sample size on convenience for the primary outcome.

Study Timeline

• Study First Submitted: 2020-10-23
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-30
• Study Start: 2020-11-10
• Primary Completion: 2021-09-26
• Study Completion: 2021-11-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients older than 18 years
2. Patient with a diagnosis of COVID-19 confirmed by PCR
3. Patient with radiological image suggestive of COVID-19 with pending confirmation
4. Need for ventilatory support with oxygen therapy by HFNC (High-flow nasal cannula)
5. Need for invasive mechanical ventilation.

Exclusion Criteria

1. Patient with an image suggestive of COVID-19 with negative PCR
2. Anticoagulation users before admission for any reason.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Syndecan-1 concentration at 10th day	24 Hours, 10 Days	Elevation of plasma Syndecan-1

Secondary Outcome Measures

Name	Time	Method
Change from Baseline IL-8 concentration at 10th day	24 Hours, 10 Days	Elevation of plasma IL-8
Change from Baseline PDGF-BB concentration at 10th day	24 Hours, 10 Days	Elevation of plasma PDGF-BB
Change from Baseline ANG-2 concentration at 10th day	24 Hours, 10 Days	Elevation of plasma ANG-2
Change from Baseline FGF basic concentration at 10th day	24 Hours, 10 Days	Elevation of plasma FGF basic
Change from Baseline HGF concentration at 10th day	24 Hours, 10 Days	Elevation of plasma HGF
Change from Baseline TIMP-1 concentration at 10th day	24 Hours, 10 Days	Elevation of plasma TIMP-1
Change from Baseline TIMP-2 concentration at 10th day	24 Hours, 10 Days	Elevation of plasma TIMP-2
Change from Baseline TNFα concentration at 10th day	24 Hours, 10 Days	Elevation of plasma TNFα
Change from Baseline VEGF concentration at 10th day	24 Hours, 10 Days	Elevation of plasma VEGF
Change from Baseline Thrombomodulin concentration at 10th day	24 Hours, 10 Days	Elevation of plasma Thrombomodulin
Major cardiovascular events	1 month, 3 months, 6 months 12 months.	Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.

Trial Locations

Locations (1)

Hospital Clínico de la Universidad de Chile; 🇨🇱 Independencia, Santiago, Chile