Endothelial Damage and Angiogenesis Biomarkers During COVID-19

• Sponsor: University of Chile (Other)
• Overall Status: Completed
• CT.gov ID: NCT04609332
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Angiogenesis; Endothelial Dysfunction; Cardiovascular Morbidity	Diagnostic Test: Endothelial damage and angiogenic biomarkers

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection
• Actual Study Start Date: Nov 10, 2020
• Actual Primary Completion Date: Sep 26, 2021
• Actual Study Completion Date: Nov 30, 2021

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Syndecan-1 concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma Syndecan-1

Secondary Outcome Measures

1. Change from Baseline ANG-2 concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma ANG-2

2. Change from Baseline FGF basic concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma FGF basic

3. Change from Baseline HGF concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma HGF

4. Change from Baseline IL-8 concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma IL-8

5. Change from Baseline PDGF-BB concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma PDGF-BB

6. Change from Baseline TIMP-1 concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma TIMP-1

7. Change from Baseline TIMP-2 concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma TIMP-2

8. Change from Baseline TNFα concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma TNFα

9. Change from Baseline VEGF concentration at 10th day [24 Hours, 10 Days]

   Elevation of plasma VEGF

10. Change from Baseline Thrombomodulin concentration at 10th day [24 Hours, 10 Days]

    Elevation of plasma Thrombomodulin

11. Major cardiovascular events [1 month, 3 months, 6 months 12 months.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínico de la Universidad de Chile	Independencia	Santiago	Chile	8380456

Sponsors and Collaborators

• University of Chile

Investigators

• Principal Investigator: Felipe Maldonado, M.D., M.Sc., Hospital Clínico de la Universidad de Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felipe Andrés Maldonado Caniulao, Principal Investigator, University of Chile
• ClinicalTrials.gov Identifier: NCT04609332
• Other Study ID Numbers: OAIC 1164/20
• First Posted: Oct 30, 2020
• Last Update Posted: Dec 10, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Felipe Andrés Maldonado Caniulao, Principal Investigator, University of Chile: Syndecan-1; Thrombomodulin; VEFG; ANG-2
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Dec 10, 2021