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

Covid19 Clinical Trial

— SARCO-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04780126
• Other study ID #: 21/090-E_COVID
• Status: Recruiting
• Start date: February 26, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2021
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
• Contact: Yale Tung Chen, MD PhD
• Phone: 0034676030131
• Email: yale.tung[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Covid19
• Sarcopenia

Intervention

Other:
• Sarcopenia diagnosis
History, physical, laboratory and ultrasound parameters to diagnose sarcopenia

Locations

Country	Name	City	State
Spain	Hospital de Emergencias Isabel Zendal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinková E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition — View Citation

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. — View Citation

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, — View Citation

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 — View Citation

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 recommend — View Citation

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. Epub 2010 Dec 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of sarcopenia	Analyze the clinical characteristics and the prevalence of sarcopenia in the patients included in the study.	1 month
Secondary	Normal values of muscle ultrasound thickness	Analyze the thickness of the rectus femoris, vastus medialis, vastus lateralis, medial gastrocnemius in all patients.	1 month
Secondary	C reactive protein (CRP) correlated to the presence of sarcopenia	Analyze the correlation between CRP and the presence of sarcopenia	1 month
Secondary	Therapy with corticosteroids impact on muscle thickness	Determine the correlation between muscle thickness and the corticotherapy received (dexamethasone, methylprednisolone, prednisone)	1 month
Secondary	Normal values of medial gastrocnemius pennation angle in all patients	Measure medial gastrocnemius pennation angle in all patients	1 month
Secondary	Ferritin correlated to the presence of sarcopenia	Analyze the correlation between Ferritin and the presence of sarcopenia	1 month
Secondary	Fibrinogen correlated to the presence of sarcopenia	Analyze the correlation between Fibrinogen and the presence of sarcopenia	1 month