SarcopeniaSARCO-COVIDNCT04780126
Sarco-COVID Study: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
An observational study of Sarcopenia and Covid19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
Trial summary
The COVID-19 pandemic is having a devastating global impact, and older adults who experience it are at higher risk of death from the disease. However, survivors of the disease have a greater risk of suffering from pathologies such as sarcopenia, which is more frequent in younger adults and with greater severity of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Covid19
- What is being tested?
- Sarcopenia diagnosis
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2021to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included.
Who may be able to join
- Over 18 years old, men or women.
- Main diagnosis is pneumonia due to COVID-19
- Subjects who, after having received information about the design, the purposes of the project, the possible risks that may arise from it and who at any time may deny their collaboration, verbally grant their consent to participate in the study.
Who cannot join
- Refusal of the patient to participate in the study.
- Present a malignant neoplasm in active phase except spino- or basal cell Ca in local stage
- Clinical situation of agony.
- Amputation of limb (s).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Emergencias Isabel Zendal
Madrid, 28046
Yale Tung Chen, MD
About this study
Official title: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
The COVID-19 pandemic is having a devastating global impact, and older adults who experience it are at higher risk of death from the disease. However, survivors of the disease have a greater risk of suffering from pathologies such as sarcopenia, which is more frequent in younger adults and with greater severity of the disease.
Sarcopenia is present in 5-13% of people between 60 and 70 years old and in 11-50% of the population over 80 years of age. The diagnosis of sarcopenia has advanced in recent years by establishing homogeneous criteria in different consensuses that necessarily combine two elements: generalized loss of strength accompanied by loss of skeletal muscle mass. Today there are three consensuses for the diagnosis of sarcopenia: the international (IWGS), the European (EWGSOP), and the most recent from a US cohort (FNIH). In all of them, the measurement of skeletal muscle mass constitutes one of the two diagnostic criteria.
Read more
The main methods to measure this muscle loss that are established are imaging techniques (computerized tomography (CT), magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DEXA) and ultrasound.
The most common ultrasound measurements used for this purpose are the muscle thickness (cm) at the point of the ultrasound path of maximum muscle thickness, the cross-sectional area (area calculated by the basic software at the point of maximum muscle thickness), and the pennation angle (angle formed between deep muscle fascia and muscle fibers). The first two measurements can be made on several long muscles, while the pennation angle is usually made primarily on the medial gastrocnemius (internal twin) muscle. They are easy to obtain, bloodless, and reproducible measurements.
Research efforts at this point in the pandemic should focus on the longer-term consequences of the disease, sequelae such as sarcopenia in patients who have suffered from COVID-19. At the same time, clinicians must become increasingly aware of the condition and its measurement integrated into clinical practice. The knowledge provided by studies such as the one presented will allow the development of specific interventions.
The risk of sarcopenia should be considered when carrying out a risk / benefit assessment of the established treatment (for example, dexamethasone), and considering a multidisciplinary treatment that includes dietary inputs.
Read the detailed description
Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included. The prevalence of sarcopenia in hospitalized patients is 15-20%. Assuming an alpha risk of 0.05 and a beta risk of 0.2 in a unilateral contrast, 64 subjects are required to detect a difference equal to or greater than 20% loss of muscle mass. A loss to follow-up rate of 0% has been estimated.
- Conditions
- Sarcopenia, Covid19
- Being tested
- Sarcopenia diagnosis
- Keywords
- sarcopenia, covid19
- Medical subject headings
- Sarcopenia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia diagnosisOther
History, physical, laboratory and ultrasound parameters to diagnose sarcopenia
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 pneumonia patients | Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included. Receives: Other: Sarcopenia diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of muscle mass
Quantify the loss of muscle mass in hospitalized patients in areas of Internal Medicine with a diagnosis of COVID-19
Measured: 1 month
Secondary outcomes (7)
Prevalence of sarcopenia
Analyze the clinical characteristics and the prevalence of sarcopenia in the patients included in the study.
Measured: 1 month
Normal values of muscle ultrasound thickness
Analyze the thickness of the rectus femoris, vastus medialis, vastus lateralis, medial gastrocnemius in all patients.
Measured: 1 month
C reactive protein (CRP) correlated to the presence of sarcopenia
Analyze the correlation between CRP and the presence of sarcopenia
Measured: 1 month
Therapy with corticosteroids impact on muscle thickness
Determine the correlation between muscle thickness and the corticotherapy received (dexamethasone, methylprednisolone, prednisone)
Measured: 1 month
Normal values of medial gastrocnemius pennation angle in all patients
Measure medial gastrocnemius pennation angle in all patients
Measured: 1 month
Ferritin correlated to the presence of sarcopenia
Analyze the correlation between Ferritin and the presence of sarcopenia
Measured: 1 month
Fibrinogen correlated to the presence of sarcopenia
Analyze the correlation between Fibrinogen and the presence of sarcopenia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start26 Feb 2021
- Primary completion30 Apr 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
- Investigators
- Yale Tung Chen, MD PhD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780126
- Sponsor's protocol ID
- 21/090-E_COVID
- Acronym
- SARCO-COVID
- Status last verified
- Mar 2021
- First submitted
- 19 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Epidemiologic and methodologic problems in determining nutritional status of older persons. Proceedings of a conference. Albuquerque, New Mexico, October 19-21, 1988. Am J Clin Nutr. 1989 Nov;50(5 Suppl):1121-235. No abstract available.
PubMed 2816807von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):129-133. doi: 10.1007/s13539-010-0014-2. Epub 2010 Dec 17.
PubMed 21475695Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.
PubMed 21527165Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
PubMed 24737557Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.
PubMed 28703496
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
- ClinicalTrials.gov ID
- NCT04780126
- Acronym / sponsor ID
- SARCO-COVID / 21/090-E_COVID
- Conditions
- Sarcopenia, Covid19
- Keywords
- sarcopenia, covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la PazUniversity, hospital or other
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 3 Mar 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.
The COVID-19 pandemic is having a devastating global impact, and older adults who experience it are at higher risk of death from the disease. However, survivors of the disease have a greater risk of suffering from pathologies such as sarcopenia, which is more frequent in younger adults and with greater severity of the disease.
Sarcopenia is present in 5-13% of people between 60 and 70 years old and in 11-50% of the population over 80 years of age. The diagnosis of sarcopenia has advanced in recent years by establishing homogeneous criteria in different consensuses that necessarily combine two elements: generalized loss of strength accompanied by loss of skeletal muscle mass. Today there are three consensuses for the diagnosis of sarcopenia: the international (IWGS), the European (EWGSOP), and the most recent from a US cohort (FNIH). In all of them, the measurement of skeletal muscle mass constitutes one of the two diagnostic criteria.
The main methods to measure this muscle loss that are established are imaging techniques (computerized tomography (CT), magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DEXA) and ultrasound.
The most common ultrasound measurements used for this purpose are the muscle thickness (cm) at the point of the ultrasound path of maximum muscle thickness, the cross-sectional area (area calculated by the basic software at the point of maximum muscle thickness), and the pennation angle (angle formed between deep muscle fascia and muscle fibers). The first two measurements can be made on several long muscles, while the pennation angle is usually made primarily on the medial gastrocnemius (internal twin) muscle. They are easy to obtain, bloodless, and reproducible measurements.
Research efforts at this point in the pandemic should focus on the longer-term consequences of the disease, sequelae such as sarcopenia in patients who have suffered from COVID-19. At the same time, clinicians must become increasingly aware of the condition and its measurement integrated into clinical practice. The knowledge provided by studies such as the one presented will allow the development of specific interventions.
The risk of sarcopenia should be considered when carrying out a risk / benefit assessment of the established treatment (for example, dexamethasone), and considering a multidisciplinary treatment that includes dietary inputs.
Detailed description
Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included. The prevalence of sarcopenia in hospitalized patients is 15-20%. Assuming an alpha risk of 0.05 and a beta risk of 0.2 in a unilateral contrast, 64 subjects are required to detect a difference equal to or greater than 20% loss of muscle mass. A loss to follow-up rate of 0% has been estimated.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 pneumonia patients | – | Other: Sarcopenia diagnosisPatients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who are admitted to the hospital and whose main diagnosis and reason for staying is COVID-19 pneumonia will be included.
Key inclusion criteria (3 listed)
- Over 18 years old, men or women.
- Main diagnosis is pneumonia due to COVID-19
- Subjects who, after having received information about the design, the purposes of the project, the possible risks that may arise from it and who at any time may deny their collaboration, verbally grant their consent to participate in the study.
Key exclusion criteria (4 listed)
- Refusal of the patient to participate in the study.
- Present a malignant neoplasm in active phase except spino- or basal cell Ca in local stage
- Clinical situation of agony.
- Amputation of limb (s).
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 |
|---|---|---|
| Sarcopenia diagnosisHistory, physical, laboratory and ultrasound parameters to diagnose sarcopenia | Other | COVID-19 pneumonia patients |
Primary outcome
Loss of muscle mass
Time frame: 1 month
Quantify the loss of muscle mass in hospitalized patients in areas of Internal Medicine with a diagnosis of COVID-19
7 secondary outcomes
Prevalence of sarcopenia
Time frame: 1 month
Normal values of muscle ultrasound thickness
Time frame: 1 month
C reactive protein (CRP) correlated to the presence of sarcopenia
Time frame: 1 month
Therapy with corticosteroids impact on muscle thickness
Time frame: 1 month
Normal values of medial gastrocnemius pennation angle in all patients
Time frame: 1 month
Ferritin correlated to the presence of sarcopenia
Time frame: 1 month
Fibrinogen correlated to the presence of sarcopenia
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Results publication: PubMed 2816807Epidemiologic and methodologic problems in determining nutritional status of older persons. Proceedings of a conference. Albuquerque, New Mexico, October 19-21, 1988. Am J Clin Nutr. 1989 Nov;50(5 Suppl):1121-235. No abstract available.
- Results publication: PubMed 21475695von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):129-133. doi: 10.1007/s13539-010-0014-2. Epub 2010 Dec 17.
- Results publication: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Results publication: PubMed 21527165Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.
- Results publication: PubMed 24737557Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
- Results publication: PubMed 28703496Nijholt W, Scafoglieri A, Jager-Wittenaar H, Hobbelen JSM, van der Schans CP. The reliability and validity of ultrasound to quantify muscles in older adults: a systematic review. J Cachexia Sarcopenia Muscle. 2017 Oct;8(5):702-712. doi: 10.1002/jcsm.12210. Epub 2017 Jul 12.
- Individual participant dataSharing planned: Undecided
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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.
Yale Tung Chen, MD PhD principal investigator
Hospital Universitario Puerta de Hierro
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 Sarcopenia and Covid19, run by Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz at 1 site in Spain.
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 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 3 Mar 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 Spain. 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 Yale Tung Chen, MD PhD (0034676030131, yale.tung@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of muscle mass (time frame: 1 month). 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 NCT04780126, which also lists 6 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 3 Mar 2021.