NCT04609332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

October 23, 2020

Last Update Submit

July 21, 2023

Conditions

Covid19AngiogenesisEndothelial DysfunctionCardiovascular Morbidity

Keywords

Syndecan-1ThrombomodulinVEFGANG-2

Outcome Measures

Primary Outcomes (1)

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

    Elevation of plasma Syndecan-1

    24 Hours, 10 Days

Secondary Outcomes (11)

  • Change from Baseline ANG-2 concentration at 10th day

    24 Hours, 10 Days

  • Change from Baseline FGF basic concentration at 10th day

    24 Hours, 10 Days

  • Change from Baseline HGF concentration at 10th day

    24 Hours, 10 Days

  • Change from Baseline IL-8 concentration at 10th day

    24 Hours, 10 Days

  • Change from Baseline PDGF-BB concentration at 10th day

    24 Hours, 10 Days

  • +6 more secondary outcomes

Interventions

Endothelial damage and angiogenic biomarkersDIAGNOSTIC_TEST

Blood samples for biomarkers study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will include Covid 19 patients admitted to ICU with the need for oxygen and ventilatory support. Blood plasma biomarkers will be obtained on the first and 10th day of hospitalization. Information on major cardiac events will be obtained from the patient clinical file and by phone interview after hospitalization.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

Location

Related 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 Cohort of COVID-19 Patients Requiring Respiratory Support. Front Med (Lausanne). 2022 Mar 16;9:826218. doi: 10.3389/fmed.2022.826218. eCollection 2022.

    PMID: 35372407RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Felipe Maldonado, M.D., M.Sc.

    Hospital Clínico de la Universidad de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2020

First Posted

October 30, 2020

Study Start

November 10, 2020

Primary Completion

September 26, 2021

Study Completion

November 30, 2021

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)