COVID-19 PneumoniaNCT04625036
NO-mediated Vascular Function in Covid-19 Patient
An observational study of COVID-19 Pneumonia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The 2019 coronavirus-induced infection (COVID-19) has caused a pandemic that has spread worldwide. Up to date, many subjects affected by the virus report important sequelae on different organs increasing morbidity and exacerbating previous pathological conditions. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Single passive leg movement
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2020to 10 May 2021
- How long will I take part?
- 1 Month
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, from acute care hospitals, diagnosed with COVID-19 pneumonia, with documented positive throat swab, within one month from discharge.
Who may be able to join
- Diagnosis of COVID-19 pneumonia
- Clinical stability condition (temperature <37.5 ° C, Respiratory Rate (RR) <22 breaths/min, Heart Rate (HR)> 50 beats/minute and <120 beats/minute, absence of major arrhythmias, hemodynamic stability)
- Possibility to reach the sitting position independently
Who cannot join
- -Previous cardiovascular, respiratory, neurological or orthopaedic diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
ICS Maugeri IRCCS, U.O. Emergenza Coronavirus di Lumezzane
Lumezzane, Brescia, 25065
About this study
Official title: Pilot Study on Peripheral Vascular Function in Covid-19 Patient
The 2019 coronavirus-induced infection (COVID-19) has caused a pandemic that has spread worldwide. Up to date, many subjects affected by the virus report important sequelae on different organs increasing morbidity and exacerbating previous pathological conditions. Mortality is also increased in cases of comorbidities such as cardiovascular disease, hypertension and diabetes. COVID-19 infection is caused by Coronavirus-2 (SARS-CoV-2). Concerning the specific interaction of SARS-CoV-2 with the cardiovascular system, we know that this virus enters the body through the receptors for the conversion of angiotensin II (ACE2r) that are present in the lungs, heart, intestinal epithelium and vascular endothelium. This receptor's availability suggests a multi-organ involvement with a consequent multi-organ dysfunction, as found in patients affected by SARS-CoV-2 infection.
Furthermore, poor vascular peripheral function -usually correlated with old age and long periods of bed rest or hypomobility- is a distinguishing characteristic of the population affected by COVID-19, as well. Thus, it is reasonable to expect that peripheral vascular function, already deteriorated by aging and common age-related diseases, can be further compromised by COVID-19 and by the forced hypomobility, typically experienced during the acute phase of the disease.
Read more
The main aim of this project will be to investigate the peripheral NO-mediated vascular function in the leg of patients recovering from Covid-19 pneumonia.
A significant vascular dysfunction is expected to be found in post COVID individuals and to be correlated to the relevant clinical variables.
Read the detailed description
The 2019 coronavirus-induced infection (COVID-19) has caused a pandemic that has spread worldwide, causing approximately 250,000 deaths to date. Even if the contagion curves seem to stabilize, many subjects have been affected by the virus and report important sequelae on the cardiovascular system. This can be explained by the assumption that COVID-19 interacts with the cardiovascular system at different levels, increasing morbidity and exacerbating previous pathological conditions. Mortality is, in fact, increased in cases of comorbidities such as cardiovascular disease, hypertension and diabetes.
COVID-19 infection is caused by Coronavirus-2 (SARS-CoV-2). This virus enters the body through the receptor for the conversion of angiotensin [angiotensin-converting enzyme 2, ACE2]. This receptor is present in the lungs, heart, intestinal epithelium and vascular endothelium. The receptor's availability suggests a multi-organ dysfunction, as found in patients affected by SARS-CoV-2 infection. In particular, the infection of endothelial cells or pericytes, as well as the cytokine-mediated inflammatory cascade induced by the infection, can lead to severe microvascular and macrovascular dysfunctions.
It is important to underline that endothelial damage is one of the precursors of the atherosclerosis and endothelial dysfunction is related to pulmonary, cardiac and neurological diseases. Furthermore, poor vascular function is related to old age and long periods of bed rest or hypomobility, those characteristics are present in the population affected by COVID-19, as well. Thus, it is reasonable to expect that peripheral vascular function, already deteriorated by aging and common age-related diseases, can be further compromised by COVID-19 and by the forced hypomobility typically experienced during the acute phase of the disease.
Recently, the endothelial function mediated by nitric oxide (NO) has been easily and non-invasively investigated on common femoral artery with the ultrasound technique of Single Passive Leg Movement. The main aim of this project will be to investigate the NO-mediated vascular function in patients recovering from Covid-19 pneumonia, within one month from discharge in order to verify the presence of endothelial dysfunction acutely induced by the viral infection.
The secondary aim will be to evaluate the correlation between NO-mediated vascular function (evaluated by ultrasound technique) and age, anthropometric parameters (height, weight, Body Mass Index), clinical parameters, oxygenation status, physical performance and pharmacology.
The data will be analysed with the Shapiro-Wilk test to evaluate their "normality" and will be presented as mean ± standard deviation (sd) or median (interquartile range) depending on the type of distribution detected. Correlation tests (Pearson/Spearman) between ultrasound evaluation on peripheral blood flow and vessels and oxygenation levels, clinical, anthropometric and physical performance measures will then be performed. Values of p <0.05 will be considered significant.
A significant peripheral vascular dysfunction is expected to be found in post COVID individuals and to be correlated to relevant clinical variables (i.e. muscle strength, respiratory parameters, oxygenation status).
- Conditions
- COVID-19 Pneumonia
- Being tested
- Single passive leg movement
- Keywords
- COVID -19, Vascular function, Endothelial function
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single passive leg movementDiagnostic test
The investigation consists of a non-invasive evaluation by ultrasounds performed on the common femoral artery investigating the speed of arterial blood flow [Leg Blood Flow LBF] and diameter of vessel with a dedicated ultrasound system (General Electric Medical Systems, Milwaukee, WI) using Doppler method, before and after a passive flexion-extension movement of the knee. A linear probe will be used with a frequency of 5 MHz. Using the diameter of the artery and the average volume (Vmean), the LBF will be calculated every second with the formula=Average volume*PiGreco*(vessel diameter / 2)2*60.
The subject will be placed in a sitting position for 20 minutes before the test. The protocol consists of image acquisition for 60 seconds (basal measurement), followed by a passive flexion-extension of the knee (single passive leg movement). The knee flexion will be performed by health care personnel at a rate of 1 Hz. At the end of the movement, the recording will continue for 60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: COVID-19 patients | Patients, from acute care hospitals, diagnosed with COVID-19 pneumonia, with documented positive throat swab, within one month from discharge. Receives: Diagnostic Test: Single passive leg movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg Blood Flow
Leg Blood Flow will be analyzed with an ultrasound examination using the Single Passive Leg Movement technique.
In particular, the investigation consists of an ultrasound performed on the common femoral artery using Doppler method with a linear probe with a frequency of 5 MHz.
The subject will be placed in a sitting position at rest for 20 minutes before the test is performed. The protocol consists of image acquisition for 60 seconds (basal measurement), followed by a passive flexion-extension of the knee performed by health care personnel at a rate of 1 Hz. At the end of the movement, the recording will continue for another 60 seconds.
Measured: Baseline
Secondary outcomes (12)
Clinical evaluations
Routinary measures as single anthropometric data: height (cm) and weight (Kg) and aggregate measure as body mass index (Kg/m2)
Measured: Baseline
Clinical characteristics
Clinical course of disease (days) will be noted for all subjects
Measured: Baseline
Presence of device
Ventilatory support (yes or no) will be noted for all subjects
Measured: Baseline
Therapy
Drug therapy (list of drugs) will be noted for all subjects
Measured: Baseline
Clinical characteristics
Number of comorbidities will be noted for all subjects
Measured: Baseline
Biochemical evaluations - ProBNP
All subjects will perform blood tests to investigate bio-humoral data. Normal values: <125 pg/mL
Measured: Baseline
Biochemical evaluations - D-dimer
All subjects will perform blood tests to investigate bio-humoral data. Normal values:<500 ng/mL FEU
Measured: Baseline
Biochemical evaluations - PCR
All subjects will perform blood tests to investigate bio-humoral data. Normal values:<=5.00 mg/L
Measured: Baseline
Functional evaluations - 1-Minute Sit To Stand
Therapists ask the participants to sit down on a chair without armrests. The assisted use of the arms is not allowed during the STS test. The therapists instruct the participants to complete as many sit-to-stand cycles as possible within 60 s at self-paced speed and count the number of fully-completed STS cycles. Normal values: 50/min-27/min.
Measured: Baseline
Functional evaluations - 6-Minute Walking Test
The 6MWT is a self-paced test of walking capacity. Patients will be asked to walk as far as possible in 6 min along a flat corridor. The distance in metres is recorded. Standardised instructions and encouragement are given during the test.
Predicted 6MW Distance follows this calculation: 361-(age in yrs x 4) + (height in cm x 2) + (HRmax/HRmax % pred x 3) - (weight in kg x 1.5) - 30 (if females).
Measured: Baseline
Functional evaluations - Biceps' muscle strength with dynamometer
The patient will be seated with the elbow flexed 90" and forearm supinated; the dynamometer will be positioned just proximal to styloid processes and the patient will be asked to flex his elbow. Prediction equation=229.421-84.836*(0=male, 1=female) +0,165*weight-1.503*age.
Measured: Baseline
Functional evaluations - Quadriceps' muscle strength with dynamometer
The patients will be seated with hips and knees flexed 90''; the dynamometer will be positioned just proximal to malleoli and the patient will be asked to extend his knee. Prediction equation=358.455-87.581*(0=male, 1=female) +0.297*weight-3.136*age
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start30 May 2020
- Primary completion30 Apr 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Principal investigator, Paola Baiardi, Istituti Clinici Scientifici Maugeri SpA
- Investigators
- Mara Paneroni, PT, Principal investigator, Istituti Clinici Scientifici Maugeri IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625036
- Sponsor's protocol ID
- ICS Maugeri 2437 CE
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.
PubMed 32352535Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
PubMed 32142651Venturelli M, Layec G, Trinity J, Hart CR, Broxterman RM, Richardson RS. Single passive leg movement-induced hyperemia: a simple vascular function assessment without a chronotropic response. J Appl Physiol (1985). 2017 Jan 1;122(1):28-37. doi: 10.1152/japplphysiol.00806.2016. Epub 2016 Nov 10.
PubMed 27834672Broxterman RM, Trinity JD, Gifford JR, Kwon OS, Kithas AC, Hydren JR, Nelson AD, Morgan DE, Jessop JE, Bledsoe AD, Richardson RS. Single passive leg movement assessment of vascular function: contribution of nitric oxide. J Appl Physiol (1985). 2017 Dec 1;123(6):1468-1476. doi: 10.1152/japplphysiol.00533.2017. Epub 2017 Aug 31.
PubMed 28860173Trinity JD, Groot HJ, Layec G, Rossman MJ, Ives SJ, Runnels S, Gmelch B, Bledsoe A, Richardson RS. Nitric oxide and passive limb movement: a new approach to assess vascular function. J Physiol. 2012 Mar 15;590(6):1413-25. doi: 10.1113/jphysiol.2011.224741. Epub 2012 Feb 6.
PubMed 22310310Gifford JR, Richardson RS. CORP: Ultrasound assessment of vascular function with the passive leg movement technique. J Appl Physiol (1985). 2017 Dec 1;123(6):1708-1720. doi: 10.1152/japplphysiol.00557.2017. Epub 2017 Sep 7.
PubMed 28883048Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.
PubMed 23974352Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.
PubMed 20525717Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
PubMed 8602410Paneroni M, Pasini E, Vitacca M, Scalvini S, Comini L, Pedrinolla A, Venturelli M. Altered Vascular Endothelium-Dependent Responsiveness in Frail Elderly Patients Recovering from COVID-19 Pneumonia: Preliminary Evidence. J Clin Med. 2021 Jun 9;10(12):2558. doi: 10.3390/jcm10122558.
PubMed 34207876
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Peripheral Vascular Function in Covid-19 Patient
- ClinicalTrials.gov ID
- NCT04625036
- Acronym / sponsor ID
- ICS Maugeri 2437 CE
- Conditions
- COVID-19 Pneumonia
- Keywords
- COVID -19, Vascular function, Endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 30 May 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 12 Nov 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 2019 coronavirus-induced infection (COVID-19) has caused a pandemic that has spread worldwide. Up to date, many subjects affected by the virus report important sequelae on different organs increasing morbidity and exacerbating previous pathological conditions. Mortality is also increased in cases of comorbidities such as cardiovascular disease, hypertension and diabetes. COVID-19 infection is caused by Coronavirus-2 (SARS-CoV-2). Concerning the specific interaction of SARS-CoV-2 with the cardiovascular system, we know that this virus enters the body through the receptors for the conversion of angiotensin II (ACE2r) that are present in the lungs, heart, intestinal epithelium and vascular endothelium. This receptor's availability suggests a multi-organ involvement with a consequent multi-organ dysfunction, as found in patients affected by SARS-CoV-2 infection.
Furthermore, poor vascular peripheral function -usually correlated with old age and long periods of bed rest or hypomobility- is a distinguishing characteristic of the population affected by COVID-19, as well. Thus, it is reasonable to expect that peripheral vascular function, already deteriorated by aging and common age-related diseases, can be further compromised by COVID-19 and by the forced hypomobility, typically experienced during the acute phase of the disease.
The main aim of this project will be to investigate the peripheral NO-mediated vascular function in the leg of patients recovering from Covid-19 pneumonia.
A significant vascular dysfunction is expected to be found in post COVID individuals and to be correlated to the relevant clinical variables.
Detailed description
The 2019 coronavirus-induced infection (COVID-19) has caused a pandemic that has spread worldwide, causing approximately 250,000 deaths to date. Even if the contagion curves seem to stabilize, many subjects have been affected by the virus and report important sequelae on the cardiovascular system. This can be explained by the assumption that COVID-19 interacts with the cardiovascular system at different levels, increasing morbidity and exacerbating previous pathological conditions. Mortality is, in fact, increased in cases of comorbidities such as cardiovascular disease, hypertension and diabetes.
COVID-19 infection is caused by Coronavirus-2 (SARS-CoV-2). This virus enters the body through the receptor for the conversion of angiotensin [angiotensin-converting enzyme 2, ACE2]. This receptor is present in the lungs, heart, intestinal epithelium and vascular endothelium. The receptor's availability suggests a multi-organ dysfunction, as found in patients affected by SARS-CoV-2 infection. In particular, the infection of endothelial cells or pericytes, as well as the cytokine-mediated inflammatory cascade induced by the infection, can lead to severe microvascular and macrovascular dysfunctions.
It is important to underline that endothelial damage is one of the precursors of the atherosclerosis and endothelial dysfunction is related to pulmonary, cardiac and neurological diseases. Furthermore, poor vascular function is related to old age and long periods of bed rest or hypomobility, those characteristics are present in the population affected by COVID-19, as well. Thus, it is reasonable to expect that peripheral vascular function, already deteriorated by aging and common age-related diseases, can be further compromised by COVID-19 and by the forced hypomobility typically experienced during the acute phase of the disease.
Recently, the endothelial function mediated by nitric oxide (NO) has been easily and non-invasively investigated on common femoral artery with the ultrasound technique of Single Passive Leg Movement. The main aim of this project will be to investigate the NO-mediated vascular function in patients recovering from Covid-19 pneumonia, within one month from discharge in order to verify the presence of endothelial dysfunction acutely induced by the viral infection.
The secondary aim will be to evaluate the correlation between NO-mediated vascular function (evaluated by ultrasound technique) and age, anthropometric parameters (height, weight, Body Mass Index), clinical parameters, oxygenation status, physical performance and pharmacology.
The data will be analysed with the Shapiro-Wilk test to evaluate their "normality" and will be presented as mean ± standard deviation (sd) or median (interquartile range) depending on the type of distribution detected. Correlation tests (Pearson/Spearman) between ultrasound evaluation on peripheral blood flow and vessels and oxygenation levels, clinical, anthropometric and physical performance measures will then be performed. Values of p <0.05 will be considered significant.
A significant peripheral vascular dysfunction is expected to be found in post COVID individuals and to be correlated to relevant clinical variables (i.e. muscle strength, respiratory parameters, oxygenation status).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: COVID-19 patients | – | Diagnostic Test: Single passive leg movementPatients, from acute care hospitals, diagnosed with COVID-19 pneumonia, with documented positive throat swab, within one month from discharge. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, from acute care hospitals, diagnosed with COVID-19 pneumonia, with documented positive throat swab, within one month from discharge.
Key inclusion criteria (3 listed)
- Diagnosis of COVID-19 pneumonia
- Clinical stability condition (temperature <37.5 ° C, Respiratory Rate (RR) <22 breaths/min, Heart Rate (HR)> 50 beats/minute and <120 beats/minute, absence of major arrhythmias, hemodynamic stability)
- Possibility to reach the sitting position independently
Key exclusion criteria (1 listed)
- -Previous cardiovascular, respiratory, neurological or orthopaedic diseases.
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 |
|---|---|---|
| Single passive leg movementThe investigation consists of a non-invasive evaluation by ultrasounds performed on the common femoral artery investigating the speed of arterial blood flow [Leg Blood Flow LBF] and diameter of vessel with a dedicated ultrasound system (General Electric Medical Systems, Milwaukee, WI) using Doppler method, before and after a passive flexion-extension movement of the knee. A linear probe will be used with a frequency of 5 MHz. Using the diameter of the artery and the average volume (Vmean), the LBF will be calculated every second with the formula=Average volume*PiGreco*(vessel diameter / 2)2*60. The subject will be placed in a sitting position for 20 minutes before the test. The protocol consists of image acquisition for 60 seconds (basal measurement), followed by a passive flexion-extension of the knee (single passive leg movement). The knee flexion will be performed by health care personnel at a rate of 1 Hz. At the end of the movement, the recording will continue for 60 seconds. | Diagnostic test | Group 1: COVID-19 patients |
Primary outcome
Leg Blood Flow
Time frame: Baseline
Leg Blood Flow will be analyzed with an ultrasound examination using the Single Passive Leg Movement technique. In particular, the investigation consists of an ultrasound performed on the common femoral artery using Doppler method with a linear probe with a frequency of 5 MHz. The subject will be placed in a sitting position at rest for 20 minutes before the test is performed. The protocol consists of image acquisition for 60 seconds (basal measurement), followed by a passive flexion-extension of the knee performed by health care personnel at a rate of 1 Hz. At the end of the movement, the recording will continue for another 60 seconds.
12 secondary outcomes
Clinical evaluations
Time frame: Baseline
Clinical characteristics
Time frame: Baseline
Presence of device
Time frame: Baseline
Therapy
Time frame: Baseline
Clinical characteristics
Time frame: Baseline
Biochemical evaluations - ProBNP
Time frame: Baseline
Biochemical evaluations - D-dimer
Time frame: Baseline
Biochemical evaluations - PCR
Time frame: Baseline
Functional evaluations - 1-Minute Sit To Stand
Time frame: Baseline
Functional evaluations - 6-Minute Walking Test
Time frame: Baseline
Functional evaluations - Biceps' muscle strength with dynamometer
Time frame: Baseline
Functional evaluations - Quadriceps' muscle strength with dynamometer
Time frame: Baseline
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 14 Apr 2022.
- Background: PubMed 32352535Guzik TJ, Mohiddin SA, Dimarco A, Patel V, Savvatis K, Marelli-Berg FM, Madhur MS, Tomaszewski M, Maffia P, D'Acquisto F, Nicklin SA, Marian AJ, Nosalski R, Murray EC, Guzik B, Berry C, Touyz RM, Kreutz R, Wang DW, Bhella D, Sagliocco O, Crea F, Thomson EC, McInnes IB. COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options. Cardiovasc Res. 2020 Aug 1;116(10):1666-1687. doi: 10.1093/cvr/cvaa106.
- Background: PubMed 32142651Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5.
- Background: PubMed 27834672Venturelli M, Layec G, Trinity J, Hart CR, Broxterman RM, Richardson RS. Single passive leg movement-induced hyperemia: a simple vascular function assessment without a chronotropic response. J Appl Physiol (1985). 2017 Jan 1;122(1):28-37. doi: 10.1152/japplphysiol.00806.2016. Epub 2016 Nov 10.
- Background: PubMed 28860173Broxterman RM, Trinity JD, Gifford JR, Kwon OS, Kithas AC, Hydren JR, Nelson AD, Morgan DE, Jessop JE, Bledsoe AD, Richardson RS. Single passive leg movement assessment of vascular function: contribution of nitric oxide. J Appl Physiol (1985). 2017 Dec 1;123(6):1468-1476. doi: 10.1152/japplphysiol.00533.2017. Epub 2017 Aug 31.
- Background: PubMed 22310310Trinity JD, Groot HJ, Layec G, Rossman MJ, Ives SJ, Runnels S, Gmelch B, Bledsoe A, Richardson RS. Nitric oxide and passive limb movement: a new approach to assess vascular function. J Physiol. 2012 Mar 15;590(6):1413-25. doi: 10.1113/jphysiol.2011.224741. Epub 2012 Feb 6.
- Background: PubMed 28883048Gifford JR, Richardson RS. CORP: Ultrasound assessment of vascular function with the passive leg movement technique. J Appl Physiol (1985). 2017 Dec 1;123(6):1708-1720. doi: 10.1152/japplphysiol.00557.2017. Epub 2017 Sep 7.
- Background: PubMed 23974352Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.
- Background: PubMed 20525717Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.
- Background: PubMed 8602410Andrews AW, Thomas MW, Bohannon RW. Normative values for isometric muscle force measurements obtained with hand-held dynamometers. Phys Ther. 1996 Mar;76(3):248-59. doi: 10.1093/ptj/76.3.248.
- Results publication: PubMed 34207876Paneroni M, Pasini E, Vitacca M, Scalvini S, Comini L, Pedrinolla A, Venturelli M. Altered Vascular Endothelium-Dependent Responsiveness in Frail Elderly Patients Recovering from COVID-19 Pneumonia: Preliminary Evidence. J Clin Med. 2021 Jun 9;10(12):2558. doi: 10.3390/jcm10122558.
- 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.
Mara Paneroni, PT principal investigator
Istituti Clinici Scientifici Maugeri IRCCS
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 COVID-19 Pneumonia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 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 14 Apr 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 Italy. 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?
Leg Blood Flow (time frame: Baseline). 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 NCT04625036, which also lists 10 linked publications.
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 14 Apr 2022.