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Completed

NCT Number: NCT04609332

Endothelial Damage and Angiogenesis Biomarkers During COVID-19

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.

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Key information

Conditions

Covid19 Angiogenesis COVID-19 Cardiovascular Morbidity Coronaviridae Infections Coronavirus Infections Endothelial Dysfunction Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endothelial damage and angiogenic biomarkers

Diagnostic Test

Blood samples for biomarkers study

Primary outcomes

  1. Change from Baseline Syndecan-1 concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma Syndecan-1

Secondary outcomes

  1. Change from Baseline ANG-2 concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma ANG-2

  2. Change from Baseline FGF basic concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma FGF basic

  3. Change from Baseline HGF concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma HGF

  4. Change from Baseline IL-8 concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma IL-8

  5. Change from Baseline PDGF-BB concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma PDGF-BB

  6. Change from Baseline TIMP-1 concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma TIMP-1

  7. Change from Baseline TIMP-2 concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma TIMP-2

  8. Change from Baseline TNFα concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma TNFα

  9. Change from Baseline VEGF concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma VEGF

  10. Change from Baseline Thrombomodulin concentration at 10th day

    Time frame: 24 Hours, 10 Days

    Elevation of plasma Thrombomodulin

  11. Major cardiovascular events

    Time frame: 1 month, 3 months, 6 months 12 months.

    Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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