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Endothelial Damage and Angiogenesis Biomarkers During COVID-19

Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04609332
Enrollment
40
Registered
2020-10-30
Start date
2020-11-10
Completion date
2021-11-30
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiogenesis, Cardiovascular Morbidity, Covid19, Endothelial Dysfunction

Keywords

Syndecan-1, Thrombomodulin, VEFG, ANG-2

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.

Interventions

DIAGNOSTIC_TESTEndothelial damage and angiogenic biomarkers

Blood samples for biomarkers study

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline Syndecan-1 concentration at 10th day24 Hours, 10 DaysElevation of plasma Syndecan-1

Secondary

MeasureTime frameDescription
Change from Baseline ANG-2 concentration at 10th day24 Hours, 10 DaysElevation of plasma ANG-2
Change from Baseline FGF basic concentration at 10th day24 Hours, 10 DaysElevation of plasma FGF basic
Change from Baseline HGF concentration at 10th day24 Hours, 10 DaysElevation of plasma HGF
Change from Baseline IL-8 concentration at 10th day24 Hours, 10 DaysElevation of plasma IL-8
Change from Baseline VEGF concentration at 10th day24 Hours, 10 DaysElevation of plasma VEGF
Change from Baseline TNFα concentration at 10th day24 Hours, 10 DaysElevation of plasma TNFα
Change from Baseline PDGF-BB concentration at 10th day24 Hours, 10 DaysElevation of plasma PDGF-BB
Change from Baseline TIMP-1 concentration at 10th day24 Hours, 10 DaysElevation of plasma TIMP-1
Change from Baseline TIMP-2 concentration at 10th day24 Hours, 10 DaysElevation of plasma TIMP-2
Major cardiovascular events1 month, 3 months, 6 months 12 months.Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.
Change from Baseline Thrombomodulin concentration at 10th day24 Hours, 10 DaysElevation of plasma Thrombomodulin

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026