Coronavirus InfectionNCT04406545
Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of COVID-19.
An observational study of Coronavirus Infection and Endothelial Dysfunction, run by National Institute of Cardiology, Laranjeiras, Brazil at 1 site in Brazil.
Trial summary
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, Endothelial Dysfunction, Microvascular Rarefaction
- What is being tested?
- evaluation of skin microvascular flow and reactivity
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- 15 May 2020to 10 Jan 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - We will include adult patients will with SARS-CoV-2 positive RT-PCR, admitted to the hospital in a ward or intensive care unit.
Who may be able to join
None listed.
Who cannot join
- Presence of non-COVID infection with systemic and microbiologically documented repercussions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-19.
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
Read the detailed description
An association between the presence of previous cardiovascular disease and adverse prognosis has been demonstrated in patients with COVID-19 (coronavirus disease-19), presenting increases of up to 5-10 times in mortality.
As an initial process, the SARS-CoV-2 virus, anchored in the transmembrane angiotensin-converting enzyme 2 (ECA2), penetrates host cells, including endothelial cells, pericytes and macrophages, in addition to type II pneumocytes.
Cellular invasion results in massive release of several pro-inflammatory cytokines ("cytokine storm"), such as IL-1β, IFN-1 and IL-6, by the cells of the immune system. In turn, cytokines increase the process of vascular inflammation and the expression of leukocyte-vascular endothelium adhesion proteins, which results in endothelial activation accompanied by a pro-coagulant and pro-adhesive phenotype - between leukocytes, platelets, red blood cells and vascular endothelium - characteristic of the dysfunctional endothelium in the microcirculation, which results in severe changes in the microvascular flow and, as a result, in tissue perfusion.
It is also worth noting that the patients most vulnerable to the development of complications are those with pre-existing endothelial dysfunction, associated with several risk factors such as male gender and smoking, and comorbidities such as hypertension, diabetes and obesity, all of which are associated with poor prognosis in COVID -19.
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also evaluating associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
- Being tested
- evaluation of skin microvascular flow and reactivity
- Medical subject headings
- Coronavirus Infections, Microvascular Rarefaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of skin microvascular flow and reactivityOther
evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | skin laser Doppler perfusion monitoring before and after local thermal hyperemia Receives: Other: evaluation of skin microvascular flow and reactivity | |
| cardiovascular disease and COVID-19 infection | skin laser Doppler perfusion monitoring before and after local thermal hyperemia Receives: Other: evaluation of skin microvascular flow and reactivity | |
| cardiovascular disease without COVID-19 infection | skin laser Doppler perfusion monitoring before and after local thermal hyperemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19.
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Measured: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
Secondary outcomes (1)
To evaluate, using laser Doppler perfusion monitoring, the presence of changes in systemic microvascular endothelial function in patients twelve months after COVID-19 recovery.
Skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Measured: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start15 May 2020
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, Brazil
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406545
- Sponsor's protocol ID
- #CAAE 31237220.1.0000.5272
- Status last verified
- Jan 2022
- First submitted
- 23 May 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-19.
- ClinicalTrials.gov ID
- NCT04406545
- Acronym / sponsor ID
- #CAAE 31237220.1.0000.5272
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Laranjeiras, BrazilOther government
- Study start
- 15 May 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 28 May 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.
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
Detailed description
An association between the presence of previous cardiovascular disease and adverse prognosis has been demonstrated in patients with COVID-19 (coronavirus disease-19), presenting increases of up to 5-10 times in mortality.
As an initial process, the SARS-CoV-2 virus, anchored in the transmembrane angiotensin-converting enzyme 2 (ECA2), penetrates host cells, including endothelial cells, pericytes and macrophages, in addition to type II pneumocytes.
Cellular invasion results in massive release of several pro-inflammatory cytokines ("cytokine storm"), such as IL-1β, IFN-1 and IL-6, by the cells of the immune system. In turn, cytokines increase the process of vascular inflammation and the expression of leukocyte-vascular endothelium adhesion proteins, which results in endothelial activation accompanied by a pro-coagulant and pro-adhesive phenotype - between leukocytes, platelets, red blood cells and vascular endothelium - characteristic of the dysfunctional endothelium in the microcirculation, which results in severe changes in the microvascular flow and, as a result, in tissue perfusion.
It is also worth noting that the patients most vulnerable to the development of complications are those with pre-existing endothelial dysfunction, associated with several risk factors such as male gender and smoking, and comorbidities such as hypertension, diabetes and obesity, all of which are associated with poor prognosis in COVID -19.
Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also evaluating associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: evaluation of skin microvascular flow and reactivityskin laser Doppler perfusion monitoring before and after local thermal hyperemia |
| cardiovascular disease and COVID-19 infection | – | Other: evaluation of skin microvascular flow and reactivityskin laser Doppler perfusion monitoring before and after local thermal hyperemia |
| cardiovascular disease without COVID-19 infection | – | –skin laser Doppler perfusion monitoring before and after local thermal hyperemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - We will include adult patients will with SARS-CoV-2 positive RT-PCR, admitted to the hospital in a ward or intensive care unit.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Presence of non-COVID infection with systemic and microbiologically documented repercussions.
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 |
|---|---|---|
| evaluation of skin microvascular flow and reactivityevaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring | Other | cardiovascular disease and COVID-19 infection, healthy volunteers |
Primary outcome
To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19.
Time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
1 secondary outcome
To evaluate, using laser Doppler perfusion monitoring, the presence of changes in systemic microvascular endothelial function in patients twelve months after COVID-19 recovery.
Time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room
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 27 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Coronavirus Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronavirus Infection and Endothelial Dysfunction, run by National Institute of Cardiology, Laranjeiras, Brazil 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 0 inclusion and 1 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 27 Jan 2022. 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?
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?
To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19. (time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.). 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 27 Jan 2022.