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

March 2, 2021 updated by: Yale Tung Chen, Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital de Emergencias Isabel Zendal
        • Contact:
          • Yale Tung Chen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of sarcopenia
Time Frame: 1 month
Analyze the clinical characteristics and the prevalence of sarcopenia in the patients included in the study.
1 month
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.
1 month
C reactive protein (CRP) correlated to the presence of sarcopenia
Time Frame: 1 month
Analyze the correlation between CRP and the presence of sarcopenia
1 month
Therapy with corticosteroids impact on muscle thickness
Time Frame: 1 month
Determine the correlation between muscle thickness and the corticotherapy received (dexamethasone, methylprednisolone, prednisone)
1 month
Normal values of medial gastrocnemius pennation angle in all patients
Time Frame: 1 month
Measure medial gastrocnemius pennation angle in all patients
1 month
Ferritin correlated to the presence of sarcopenia
Time Frame: 1 month
Analyze the correlation between Ferritin and the presence of sarcopenia
1 month
Fibrinogen correlated to the presence of sarcopenia
Time Frame: 1 month
Analyze the correlation between Fibrinogen and the presence of sarcopenia
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

Investigators

  • Principal Investigator: Yale Tung Chen, MD PhD, Hospital Universitario Puerta de Hierro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2021

Primary Completion (Anticipated)

April 30, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/090-E_COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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