Endothelial Damage and Angiogenesis Biomarkers During COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609332
• Other study ID #: OAIC 1164/20
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: July 2023
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2021
• Est. primary completion date: September 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiogenesis
• Cardiovascular Morbidity
• COVID-19
• Covid19
• Endothelial Dysfunction

Intervention

Diagnostic Test:
• Endothelial damage and angiogenic biomarkers
Blood samples for biomarkers study

Locations

Country	Name	City	State
Chile	Hospital Clínico de la Universidad de Chile	Independencia	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Maldonado F, Morales D, Diaz-Papapietro C, Valdes C, Fernandez C, Valls N, Lazo M, Espinoza C, Gonzalez R, Gutierrez R, Jara A, Romero C, Cerda O, Caceres M. Relationship Between Endothelial and Angiogenesis Biomarkers Envisage Mortality in a Prospective — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Syndecan-1 concentration at 10th day	Elevation of plasma Syndecan-1	24 Hours, 10 Days
Secondary	Change from Baseline ANG-2 concentration at 10th day	Elevation of plasma ANG-2	24 Hours, 10 Days
Secondary	Change from Baseline FGF basic concentration at 10th day	Elevation of plasma FGF basic	24 Hours, 10 Days
Secondary	Change from Baseline HGF concentration at 10th day	Elevation of plasma HGF	24 Hours, 10 Days
Secondary	Change from Baseline IL-8 concentration at 10th day	Elevation of plasma IL-8	24 Hours, 10 Days
Secondary	Change from Baseline PDGF-BB concentration at 10th day	Elevation of plasma PDGF-BB	24 Hours, 10 Days
Secondary	Change from Baseline TIMP-1 concentration at 10th day	Elevation of plasma TIMP-1	24 Hours, 10 Days
Secondary	Change from Baseline TIMP-2 concentration at 10th day	Elevation of plasma TIMP-2	24 Hours, 10 Days
Secondary	Change from Baseline TNFa concentration at 10th day	Elevation of plasma TNFa	24 Hours, 10 Days
Secondary	Change from Baseline VEGF concentration at 10th day	Elevation of plasma VEGF	24 Hours, 10 Days
Secondary	Change from Baseline Thrombomodulin concentration at 10th day	Elevation of plasma Thrombomodulin	24 Hours, 10 Days
Secondary	Major cardiovascular events	Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.	1 month, 3 months, 6 months 12 months.