Clinical trial NCT04780126: Sarco-COVID Study: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
Official title: Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Covid19
Keywords: sarcopenia
covid19
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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).

Primary outcomes:
measure: Loss of muscle mass
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence of sarcopenia
timeFrame: 1 month
measure: Normal values of muscle ultrasound thickness
timeFrame: 1 month
measure: C reactive protein (CRP) correlated to the presence of sarcopenia
timeFrame: 1 month
measure: Therapy with corticosteroids impact on muscle thickness
timeFrame: 1 month
measure: Normal values of medial gastrocnemius pennation angle in all patients
timeFrame: 1 month
measure: Ferritin correlated to the presence of sarcopenia
timeFrame: 1 month
measure: Fibrinogen correlated to the presence of sarcopenia
timeFrame: 1 month
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital de Emergencias Isabel Zendal
Study officials:
affiliation: Hospital Universitario Puerta de Hierro
name: Yale Tung Chen, MD PhD
role: PRINCIPAL_INVESTIGATOR
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