COVID-19HEMOCOVID19NCT04689477
Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
An observational study of COVID-19 and Endothelial Function, run by Corporacion Parc Tauli at 8 sites in 4 countries.
Trial summary
The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Endothelial Function
- What is being tested?
- Vascular occlusion test
- Type of treatment
- Medical device
- How many people
- 612 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 25 May 2020to Oct 2022
- How long will I take part?
- 4 Weeks
- 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: Critical COVID-19 patients with respiratory impairment admitted to the Intensive Care Unit
Who may be able to join
- Recent diagnosis of SARS-CoV2 infection
- Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.
Who cannot join
- Severe peripheral vasculopathy
- Raynaud's syndrome
- Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
- Deep venous thrombosis in the upper limbs
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites, 4 recruiting
- Recruiting
Hospital Clínic i Provincial de Barcelona
Barcelona
Pedro Castro, MD, pcastro@clinic.cat
- Recruiting
Hospital Parc Salut Mar
Barcelona
Judith Marin Corral, jmarin@imim.es
Clara Vila
- Recruiting
Hospital Vall d'Hebron
Barcelona
Ricard Ferrer, r.ferrer@vhebron.net
Marina García de Acilu
- Recruiting
Institut d'Investigació i Innovació Parc Taulí
Sabadell, Barcelona, 08208
Jaume Mesquida, +34 937231010 ext. 21155, jmesquida@tauli.cat
Alba Caballer
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clinicas da UNICAMP
Campinas, São Paulo
Rodrigo Forti, rforti@ifi.unicamp.br
Rickson Coelho Mesquita
- Recruiting
Hospital Das Clínicas University of Sao Paulo Medical School
São Paulo
Leandro U Taniguchi
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
David Busch
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México
México
Argelia Pérez Pacheco, 27892000 ext. 1853, argeliapp@ciencias.unam.mx
Diana Pineda Vázquez
About this study
The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.
Read the detailed description
After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient.
Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.
- Conditions
- COVID-19, Endothelial Function
- Being tested
- Vascular occlusion test
- Keywords
- COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular occlusion testDevice
The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Hospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia. Receives: Device: Vascular occlusion test | |
| Control | Healthy subjects Receives: Device: Vascular occlusion test | |
| Non-COVID critically ill patients | Non-COVID critically ill patients admitted to the ICU. Receives: Device: Vascular occlusion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start25 May 2020
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
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 COVID-19Studies 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
- 612 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO), Centre de Recerca Matemàtica, Institute of Physics University of Campinas
- Responsible party
- Principal investigator, Jaume Mesquida, Corporacion Parc Tauli
- Investigators
- Jaume Mesquida, MD, PhD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689477
- Sponsor's protocol ID
- 2020/579
- Acronym
- HEMOCOVID19
- Status last verified
- Jul 2022
- First submitted
- 29 Dec 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Mesquida J, Caballer A, Cortese L, Vila C, Karadeniz U, Pagliazzi M, Zanoletti M, Pacheco AP, Castro P, Garcia-de-Acilu M, Mesquita RC, Busch DR, Durduran T; HEMOCOVID-19 Consortium. Peripheral microcirculatory alterations are associated with the severity of acute respiratory distress syndrome in COVID-19 patients admitted to intermediate respiratory and intensive care units. Crit Care. 2021 Nov 8;25(1):381. doi: 10.1186/s13054-021-03803-2.
PubMed 34749792
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04689477
- Acronym / sponsor ID
- HEMOCOVID19 / 2020/579
- Conditions
- COVID-19, Endothelial Function
- Keywords
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Institut de Ciències Fotòniques (ICFO), Centre de Recerca Matemàtica, Institute of Physics University of Campinas
- Study start
- 25 May 2020 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 30 Dec 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.
The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.
Detailed description
After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient.
Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | Device: Vascular occlusion testHospitalized patients diagnosed with COVID-19, presenting with arterial hypoxemia. |
| Control | – | Device: Vascular occlusion testHealthy subjects |
| Non-COVID critically ill patients | – | Device: Vascular occlusion testNon-COVID critically ill patients admitted to the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critical COVID-19 patients with respiratory impairment admitted to the Intensive Care Unit
Key inclusion criteria (2 listed)
- Recent diagnosis of SARS-CoV2 infection
- Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.
Key exclusion criteria (4 listed)
- Severe peripheral vasculopathy
- Raynaud's syndrome
- Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
- Deep venous thrombosis in the upper limbs
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 |
|---|---|---|
| Vascular occlusion testThe ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time. | Device | COVID-19, Control, Non-COVID critically ill patients |
Primary outcome
28-day mortality
Time frame: 28 days
Mortality at 28 days of patients admitted to the ICU as results of respiratory failure secondary to COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Results publication: PubMed 34749792Mesquida J, Caballer A, Cortese L, Vila C, Karadeniz U, Pagliazzi M, Zanoletti M, Pacheco AP, Castro P, Garcia-de-Acilu M, Mesquita RC, Busch DR, Durduran T; HEMOCOVID-19 Consortium. Peripheral microcirculatory alterations are associated with the severity of acute respiratory distress syndrome in COVID-19 patients admitted to intermediate respiratory and intensive care units. Crit Care. 2021 Nov 8;25(1):381. doi: 10.1186/s13054-021-03803-2.
- Related InfoLink provided by the sponsor.
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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.
Jaume Mesquida, MD, PhD principal investigator
Corporacion Parc Tauli
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Endothelial Function, run by Corporacion Parc Tauli at 8 sites in 4 countries.
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 2 inclusion and 4 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Brazil, United States, Mexico. 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 Jaume Mesquida, MD, PhD (+34 937231010 ext. 21155, jmesquida@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 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 NCT04689477, 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 1 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.