Covid19NCT04609332
Endothelial Damage and Angiogenesis Biomarkers During COVID-19
An observational study of Covid19 and Angiogenesis, run by University of Chile at 1 site in Chile.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Angiogenesis, Endothelial Dysfunction
- What is being tested?
- Endothelial damage and angiogenic biomarkers
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 10 Nov 2020to 30 Nov 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient with an image suggestive of COVID-19 with negative PCR
- Anticoagulation users before admission for any reason.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico de la Universidad de Chile
Independencia, Santiago Metropolitan, 8380456
About this study
Official title: Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection
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.
Read the 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.
- Being tested
- Endothelial damage and angiogenic biomarkers
- Keywords
- Syndecan-1, Thrombomodulin, VEFG, ANG-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial damage and angiogenic biomarkersDiagnostic test
Blood samples for biomarkers study
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Syndecan-1 concentration at 10th day
Elevation of plasma Syndecan-1
Measured: 24 Hours, 10 Days
Secondary outcomes (11)
Change from Baseline ANG-2 concentration at 10th day
Elevation of plasma ANG-2
Measured: 24 Hours, 10 Days
Change from Baseline FGF basic concentration at 10th day
Elevation of plasma FGF basic
Measured: 24 Hours, 10 Days
Change from Baseline HGF concentration at 10th day
Elevation of plasma HGF
Measured: 24 Hours, 10 Days
Change from Baseline IL-8 concentration at 10th day
Elevation of plasma IL-8
Measured: 24 Hours, 10 Days
Change from Baseline PDGF-BB concentration at 10th day
Elevation of plasma PDGF-BB
Measured: 24 Hours, 10 Days
Change from Baseline TIMP-1 concentration at 10th day
Elevation of plasma TIMP-1
Measured: 24 Hours, 10 Days
Change from Baseline TIMP-2 concentration at 10th day
Elevation of plasma TIMP-2
Measured: 24 Hours, 10 Days
Change from Baseline TNFα concentration at 10th day
Elevation of plasma TNFα
Measured: 24 Hours, 10 Days
Change from Baseline VEGF concentration at 10th day
Elevation of plasma VEGF
Measured: 24 Hours, 10 Days
Change from Baseline Thrombomodulin concentration at 10th day
Elevation of plasma Thrombomodulin
Measured: 24 Hours, 10 Days
Major cardiovascular events
Acute coronary syndrome, myocardial injury, pulmonary embolism, and death.
Measured: 1 month, 3 months, 6 months 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start10 Nov 2020
- Primary completion26 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Andrés Maldonado Caniulao, University of Chile
- Investigators
- Felipe Maldonado, M.D., M.Sc., Principal investigator, Hospital Clínico de la Universidad de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609332
- Sponsor's protocol ID
- OAIC 1164/20
- Status last verified
- Jul 2023
- First submitted
- 23 Oct 2020
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35372407
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Endothelial Damage and Angiogenesis Biomarkers With Morbidity and Mortality in SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04609332
- Acronym / sponsor ID
- OAIC 1164/20
- Keywords
- Syndecan-1, Thrombomodulin, VEFG, ANG-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 26 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient with an image suggestive of COVID-19 with negative PCR
- Anticoagulation users before admission for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial damage and angiogenic biomarkersBlood samples for biomarkers study | Diagnostic test | – |
Primary outcome
Change from Baseline Syndecan-1 concentration at 10th day
Time frame: 24 Hours, 10 Days
Elevation of plasma Syndecan-1
11 secondary outcomes
Change from Baseline ANG-2 concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline FGF basic concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline HGF concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline IL-8 concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline PDGF-BB concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline TIMP-1 concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline TIMP-2 concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline TNFα concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline VEGF concentration at 10th day
Time frame: 24 Hours, 10 Days
Change from Baseline Thrombomodulin concentration at 10th day
Time frame: 24 Hours, 10 Days
Major cardiovascular events
Time frame: 1 month, 3 months, 6 months 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Results publication: PubMed 35372407Maldonado 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Maldonado, M.D., M.Sc. principal investigator
Hospital Clínico de la Universidad de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Angiogenesis, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Syndecan-1 concentration at 10th day (time frame: 24 Hours, 10 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.