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

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ClinicalTrials.gov Identifier: NCT04780126
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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.


Condition or disease Intervention/treatment
Sarcopenia Covid19 Other: Sarcopenia diagnosis

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 64 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021

Group/Cohort Intervention/treatment
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
History, physical, laboratory and ultrasound parameters to diagnose sarcopenia




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Prevalence of sarcopenia [ Time Frame: 1 month ]
    Analyze the clinical characteristics and the prevalence of sarcopenia in the patients included in the study.

  2. Normal values of muscle ultrasound thickness [ Time Frame: 1 month ]
    Analyze the thickness of the rectus femoris, vastus medialis, vastus lateralis, medial gastrocnemius in all patients.

  3. C reactive protein (CRP) correlated to the presence of sarcopenia [ Time Frame: 1 month ]
    Analyze the correlation between CRP and the presence of sarcopenia

  4. Therapy with corticosteroids impact on muscle thickness [ Time Frame: 1 month ]
    Determine the correlation between muscle thickness and the corticotherapy received (dexamethasone, methylprednisolone, prednisone)

  5. Normal values of medial gastrocnemius pennation angle in all patients [ Time Frame: 1 month ]
    Measure medial gastrocnemius pennation angle in all patients

  6. Ferritin correlated to the presence of sarcopenia [ Time Frame: 1 month ]
    Analyze the correlation between Ferritin and the presence of sarcopenia

  7. Fibrinogen correlated to the presence of sarcopenia [ Time Frame: 1 month ]
    Analyze the correlation between Fibrinogen and the presence of sarcopenia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780126


Contacts
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Contact: Yale Tung Chen, MD PhD 0034676030131 yale.tung@salud.madrid.org

Locations
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Spain
Hospital de Emergencias Isabel Zendal Recruiting
Madrid, Spain, 28046
Contact: Yale Tung Chen, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Investigators
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Principal Investigator: Yale Tung Chen, MD PhD Hospital Universitario Puerta de Hierro
  Study Documents (Full-Text)

Documents provided by Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
Publications of Results:

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Responsible Party: Yale Tung Chen, Principal Investigator, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
ClinicalTrials.gov Identifier: NCT04780126    
Other Study ID Numbers: 21/090-E_COVID
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz:
sarcopenia
covid19
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical