Covid19NCT04714125
Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients
An observational study of Covid19 and SARS-CoV Infection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19. The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Jun 2020to 1 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Male and female adults with SARS-CoV-2 and recently admitted (≤ 72 hours) to the General Hospital of the Faculty of Medicine of the University of Sao Paulo.
Who may be able to join
- Patients diagnosed with SARS-CoV-2
- Recently admitted to the hospital (≤ 72 hours)
- Not yet proceeded to ICU care
Who cannot join
- Patients transferred from other hospitals
- Participants in delirium state
- Participants with a recent history of endotracheal intubation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, 05403-010
Tiago Peçanha, PhD, 5511948243542, tiagopecanha@usp.br
About this study
Official title: Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study
This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19.
The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death.
Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.
Read the detailed description
This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization.
The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints.
The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- endothelial function, flow-mediated dilation, vascular function, carotid intima-media thickness
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with COVID-19 | Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
A composite outcome including ICU admission, intubation and all-cause mortality
Measured: Up to hospital discharge, an average of 4 weeks
Secondary outcomes (4)
All-cause mortality
All-cause mortality rate along the study
Measured: Up to hospital discharge, an average of 4 weeks
ICU admission
Admission to the ICU along the study
Measured: Up to hospital discharge, an average of 4 weeks
Intubation
Necessity of intubation along the study
Measured: Up to hospital discharge, an average of 4 weeks
Cardiovascular complications
Cardiovascular complications, such as arterial, deep venous or pulmonary embolism, acute myocardial infarction, stroke, cardiac arrest, atrial fibrillation and acute kidney injury
Measured: Up to hospital discharge, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Jun 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714125
- Sponsor's protocol ID
- FMDCOVID
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT04714125
- Acronym / sponsor ID
- FMDCOVID
- Conditions
- Covid19, SARS-CoV Infection
- Keywords
- endothelial function, flow-mediated dilation, vascular function, carotid intima-media thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 Jan 2021 (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.
This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19.
The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death.
Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.
Detailed description
This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization.
The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints.
The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with COVID-19 | – | –Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female adults with SARS-CoV-2 and recently admitted (≤ 72 hours) to the General Hospital of the Faculty of Medicine of the University of Sao Paulo.
Key inclusion criteria (3 listed)
- Patients diagnosed with SARS-CoV-2
- Recently admitted to the hospital (≤ 72 hours)
- Not yet proceeded to ICU care
Key exclusion criteria (3 listed)
- Patients transferred from other hospitals
- Participants in delirium state
- Participants with a recent history of endotracheal intubation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite outcome
Time frame: Up to hospital discharge, an average of 4 weeks
A composite outcome including ICU admission, intubation and all-cause mortality
4 secondary outcomes
All-cause mortality
Time frame: Up to hospital discharge, an average of 4 weeks
ICU admission
Time frame: Up to hospital discharge, an average of 4 weeks
Intubation
Time frame: Up to hospital discharge, an average of 4 weeks
Cardiovascular complications
Time frame: Up to hospital discharge, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
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 SARS-CoV Infection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Jan 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiago Peçanha, PhD (11948243542, tiagopecanha@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: Up to hospital discharge, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2021.