Sarco-COVID Study: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19

NCT04780126 | Unknown

• 1 other identifier: 21/090-E_COVID
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Sarcopenia; Covid19

Keywords

sarcopenia; covid19

Outcome Measures

Primary Outcomes (1)

• Loss of muscle mass

  Quantify the loss of muscle mass in hospitalized patients in areas of Internal Medicine with a diagnosis of COVID-19

  1 month

Secondary Outcomes (7)

• Prevalence of sarcopenia

  1 month

• Normal values of muscle ultrasound thickness

  1 month

• C reactive protein (CRP) correlated to the presence of sarcopenia

  1 month

• Therapy with corticosteroids impact on muscle thickness

  1 month

• Normal values of medial gastrocnemius pennation angle in all patients

  1 month

Study Arms (1)

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.

Other: Sarcopenia diagnosis

Interventions

Sarcopenia diagnosis OTHER

History, physical, laboratory and ultrasound parameters to diagnose sarcopenia

COVID-19 pneumonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz: lead

Study Sites (1)

Hospital de Emergencias Isabel Zendal

Madrid, 28046, Spain

RECRUITING

Related Publications (6)

• 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.

  PMID: 2816807 RESULT

• von 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.

  PMID: 21475695 RESULT

• Cruz-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.

  PMID: 20392703 RESULT

• Fielding 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.

  PMID: 21527165 RESULT

• Studenski 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.

  PMID: 24737557 RESULT

• Nijholt 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.

  PMID: 28703496 RESULT

MeSH Terms

Conditions

Sarcopenia; COVID-19

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yale Tung Chen, MD PhD

  Hospital Universitario Puerta de Hierro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yale Tung Chen, MD PhD

CONTACT

0034676030131; yale.tung@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 3, 2021
• Study Start: February 26, 2021
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

ES (1)