Measuring the Loss of Skeletal Muscle Mass in the Hospitalized Patient With the Diagnosis of COVID-19
Conditions: Sarcopenia, Covid19
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SARCO-COVID STUDY: MEASUREMENT OF MASS LOSS 
SKELETAL MUSCULAR IN THE HOSPITALIZED PATIENT WITH 
COVID-19 DIAGNOSIS 
 
 
 
PROTOCOL: 
 
Version 2.0 
 
Last updated on the 12th of February of 2021 and approved by the Research Review Board 
on the 16th of February of 2021 
 
 
 
 
 
 
 
 
 
 
INVESTIGATOR 
PRINCIPAL 
NAME 
AREA 
 
YALE TUNG CHEN 
INTERNAL MEDICINE 
 
COINVESTIGATED 
OR 
MARCOS FRAGIEL 
SAAVEDRA 
 
INTERNAL MEDICINE 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
 
INDEX 
1. SUMMARY ............................................................................................ 4 
2. GENERAL INFORMATION ............................................................ 7 
to. Study identiﬁcation 
b. Principal investigator and collaborators 
c. Research Center 
d. Ethical committee for clinical research 
and. Expected duration of the study 
F. Reason for the project 
g. Objectives of the study 
i. Main hypothesis 
ii. Main goal 
iii. Secondary objectives 
3. TYPE OF STUDY AND DESIGN ........................................................ 9 
to. Study overview 
b. Clinical study phase 
c. Deﬁnition of study population 
d. Inclusion and exclusion criteria 
and. Origin of data 
F. Project duration and schedule 
g. Sample size 
4. EVALUATION VARIABLES ........................................................ 12 
to. Demographic variables 
b. Clinical variables 
c. Variables related to physical examination 
d. Ultrasound variables 
and. Complications 
5. METHODOLOGY ................................................................................. 14 
to. Selection of study subjects 
b. Technique 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
c. Study development 
d. Study schedule 
and. Statistic analysis 
6. ETHICAL ASPECTS ........................................................................... 20 
 
to. General and particular rules for researchers 
b. Security and conﬁdentiality devices 
7. BIBLIOGRAPHY ................................................................................. 23 
8. ANNEXES ............................................................................................. 25 
to. ANNEX I: Data collection notebook 
b. ANNEX II: Conﬁdentiality commitment 
c. 
ANNEX III: Information sheet and informed consent 
d. ANNEX IV: CV of the principal investigators 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
1. SUMMARY OF THE STUDY 
 
 
 
1. Type of request: 
 
Observational validation study of prognostic test based on clinical parameters, 
analytical and ultrasound. 
2. Identiﬁcation of promoter: 
 
Working Group on Ultrasound of the Spanish Society of Internal Medicine (GT Eco- 
SEMI). 
3. Study title: 
 
"SARCO-COVID: Measurement of the loss of skeletal muscle mass in the patient 
hospitalized with a diagnosis of COVID-19 ”. 
4. Protocol Code: 
 
MIR / HEEIZ_2021_03 
 
5. Principal investigator. Address of your workplace: 
 
Dr. Yale Tung Chen and Dr. Marcos Fragiel Saavedra. 
 
University Hospital of Emergencies Nurse Isabel Zendal. 
AV. Manuel Fraga Iribarne, 2, 28055 Madrid 
6. Centers in which the study is planned: 
 
It is a study that will be carried out at the Nurse Isabel Emergency Hospital 
Zendal (Madrid). 
7. Design: 
 
Observational validation study of prognostic test based on clinical parameters, 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
analytical and ultrasound. 
 
8. Clinical Research Ethics Committee that evaluates the study: 
 
 
Following the guidelines of the center, the study will be evaluated by the Ethics Committee of 
Clinical Research of the San Carlos Clinical Hospital. 
 
9. Rationale 
 
 
 
 
The COVID-19 pandemic is having a devastating global impact, and adults 
Older people who suffer from it have a higher risk of death from the disease. Nevertheless, 
survivors of the disease are at greater risk of suffering from diseases such as 
sarcopenia, more common in younger adults and with greater severity of 
disease. 
 
Sarcopenia (from the Greek terms “ sarx” (meat) and “ penia” (poor quality)) 
today it is considered one of the most relevant syndromes, and the substrate of many of the 
health problems of the elderly and hospitalized patients, increasing by itself 
morbidity and mortality, and of course reducing activity and functional recovery. Of 
fact is deeply related to frailty, functional decline, falls, 
osteoporosis and different metabolic disorders (hydrocarbon intolerance) and 
homeostasis (thermoregulation) of the elderly. Sarcopenia is present in the 
5-13% of people between 60 and 70 years old and in 11- 50% of the population over 80 
years. 
 
The diagnosis of sarcopenia has advanced in recent years by establishing itself in 
different consensuses homogeneous criteria that necessarily combine two 
elements: general loss of strength accompanied by loss of muscle mass 
skeletal. Today there are three consensuses for the diagnosis of sarcopenia: the 
international (IWGS), European (EWGSOP), and the most recent of a cohort 
American (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 the 
imaging techniques (computerized tomography (CT), magnetic resonance imaging (MRI), 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
Dual energy X-ray absorptiometry (DEXA) and ultrasound. 
 
The most common ultrasound measurements used for this purpose are thickness 
muscle (cm) at the point of the ultrasound path of maximum muscle thickness, the area of 
cross section (area calculated by the basic software at the point of maximum 
muscle thickness), and the angle of pennation (angle formed between the muscular fascia 
deep and muscle ﬁbers). The ﬁrst two measurements can be made in several 
long muscles, while the pennation angle is usually performed mainly in the 
 
 
 
 
medial gastrocnemius muscle (internal twin). They are easy to obtain, bloodless and 
reproducible. 
 
Research efforts at this point in the pandemic should focus on 
in the longer-term consequences of the disease, sequelae such as sarcopenia in 
patients who have suffered COVID-19. At the same time, doctors must be every time 
more aware of the condition and its measurement integrated into clinical practice. The 
knowledge that studies such as the one proposed will provide will allow the development of 
speciﬁc interventions. 
 
The risk of sarcopenia should be considered when conducting an evaluation of the 
risk / beneﬁt of the established treatment (for example, dexamethasone), and assess a 
multidisciplinary treatment that includes dietary contributions. 
 
 
10. Main objectives 
 
 
1. Main hypothesis: 
• Patients admitted for COVID-19 present a progressive loss of mass 
 
muscle, both due to the inﬂammatory state, decreased intake, bedridden due to 
hospitalization and derivative of treatment (eg corticosteroid therapy). 
 
2. Main objective: 
• Quantify the loss of muscle mass in hospitalized patients in areas of Medicine 
Inmate diagnosed with COVID-19. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
3. Secondary objectives: 
 
• Analyze the clinical characteristics and prevalence of sarcopenia in patients 
included in the study. 
• Analyze the thickness and cross-sectional area of the muscles in all patients 
rectus femoris, vastus medialis, vastus lateralis, medial calf and the angle of pennation of the 
medial twin. 
• Analyze the correlation between ultrasound parameters and analytical parameters 
(nutritional, inﬂammatory). 
• Determine the relationship between muscle loss and treatment received 
 
 
 
 
(dexamethasone, methylprednisolone, prednisone). 
• Determine the relationship between muscle loss and days of hospitalization or 
severity of illness. 
 
 
 
11. Study population and total number of patients 
 
Patients over 18 years of age who are admitted to the hospital and whose 
primary diagnosis and reason for staying is COVID-19 pneumonia. The 
The prevalence of sarcopenia in hospitalized patients is 15-20%. Assuming a 
alpha risk of 0.05 and beta risk of 0.2 in a one-sided contrast, 64 subjects are required 
to detect a difference equal to or greater than 20% loss of muscle mass. It has been 
an estimated loss to follow-up rate of 0%. 
 
 
 
12. Schedule and expected date of completion 
 
The study will begin in February 2021 , with an estimated duration of 3 months (1 month 
for application, 1 month for data collection, 1 month for results analysis and 
preparation of articles and / or communications). 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
2. GENERAL I NFORMATION 
 
to. Project identiﬁcation. 
 
Protocol code: MIR / HEEIZ_2021_03 
 
Promoter: Working Group on Ultrasound of the Spanish Society of Internal Medicine 
(GT Eco-SEMI). 
Qualiﬁcation: 
 
"SARCO-COVID: Measurement of the loss of skeletal muscle mass in the patient 
hospitalized with a diagnosis of COVID-19 ”. 
 
b. Principal researchers. Work center address: 
 
Dr. Yale Tung Chen and Dr. Marcos Fragiel Saavedra. 
 
University Hospital of Emergencies Nurse Isabel Zendal. 
 
AV. Manuel Fraga Iribarne, 2, 28055 Madrid 
 
c. Research Center. 
 
Hospital de Emergencias Nurse Isabel Zendal. 
 
 
d. Ethical Committee for Clinical Research. 
 
Following the guidelines of the center, the study will be evaluated by the Ethics Committee of 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
Clinical Research of the Hospital Clínica San Carlos, whose composition is already known 
accredited by the Ministry of Health. The study will be evaluated by the CEIC of each 
hospital where the study will be performed. 
 
 
and. Expected duration of the project. 
 
The study will begin in February 2021 , with an estimated duration of 3 months (1 month 
for application, 1 month for data collection, 1 month for results analysis and 
preparation of articles and / or communications). The estimated timetable for the development of the 
study: 
Presentation to CEIC: February 2021. 
Data collection: March 2021. 
Analysis of results: April 2021 
 
Preparation of articles, communications: April 2021. 
 
F. Reason for the project. 
 
The COVID-19 pandemic is having a devastating global impact, and adults 
Older people who suffer from it have a higher risk of death from the disease. Nevertheless, 
survivors of the disease are at greater risk of suffering from diseases such as 
sarcopenia, more common in younger adults and with greater severity of 
disease. 
 
Sarcopenia (from the Greek terms “ sarx” (meat) and “ penia” (poor quality)) 
today it is considered one of the most relevant syndromes, and the substrate of many of the 
health problems of the elderly and hospitalized patients, increasing by itself 
morbidity and mortality, and of course reducing activity and functional recovery. Of 
fact is deeply related to frailty, functional decline, falls, 
osteoporosis and different metabolic disorders (hydrocarbon intolerance) and 
homeostasis (thermoregulation) of the elderly. Sarcopenia is present in the 
5-13% of people between 60 and 70 years old and in 11- 50% of the population over 80 
years. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
The diagnosis of sarcopenia has advanced in recent years by establishing itself in 
different consensuses homogeneous criteria that necessarily combine two 
elements: general loss of strength accompanied by loss of muscle mass 
skeletal. Today there are three consensuses for the diagnosis of sarcopenia: the 
international (IWGS), European (EWGSOP), and the most recent of a cohort 
American (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 the 
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 thickness 
muscle (cm) at the point of the ultrasound path of maximum muscle thickness, the area of 
 
 
 
 
 
 
cross section (area calculated by the basic software at the point of maximum 
muscle thickness), and the angle of pennation (angle formed between the muscular fascia 
deep and muscle ﬁbers). The ﬁrst two measurements can be made in several 
long muscles, while the pennation angle is usually performed mainly in the 
medial gastrocnemius muscle (internal twin). They are easy to obtain, bloodless and 
reproducible. 
 
Research efforts at this point in the pandemic should focus on 
in the longer-term consequences of the disease, sequelae such as sarcopenia in 
patients who have suffered COVID-19. At the same time, doctors must be every time 
more aware of the condition and its measurement integrated into clinical practice. The 
knowledge that studies such as the one proposed will provide will allow the development of 
speciﬁc interventions. 
 
The risk of sarcopenia should be considered when conducting an evaluation of the 
risk / beneﬁt of the established treatment (for example, dexamethasone), and assess a 
multidisciplinary treatment that includes dietary contributions. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
 
 
 
 
g. Objectives of the study. 
 
1. Main hypothesis: 
• Patients admitted for COVID-19 present a progressive loss of mass 
 
muscle, both due to the inﬂammatory state, decreased intake, bedridden due to 
hospitalization and derivative of treatment (eg corticosteroid therapy). 
 
2. Main objective: 
• Quantify the loss of muscle mass in hospitalized patients in areas of Medicine 
Inmate diagnosed with COVID-19. 
 
3. Secondary objectives: 
 
• Analyze the clinical characteristics and prevalence of sarcopenia in patients 
included in the study. 
• Analyze the thickness and cross-sectional area of the muscles in all patients 
 
rectus femoris, vastus medialis, vastus lateralis, medial calf and the angle of pennation of the 
medial twin. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
• Analyze the correlation between ultrasound parameters and analytical parameters 
(nutritional, inﬂammatory). 
• Determine the relationship between muscle loss and treatment received 
(dexamethasone, methylprednisolone, prednisone). 
 
 
 
3. T YPE OF E STUDIO AND D ESIGN 
 
to. Clinical study phase 
 
Observational validation study of prognostic test based on clinical parameters, 
analytical and ultrasound. 
 
b. Deﬁnition of study population 
 
Patients over 18 years of age who are admitted to the hospital and whose 
primary diagnosis and reason for staying is COVID-19 pneumonia. For a 
95% conﬁdence interval, with a precision level of 3%, an estimated loss in 
 
 
 
about 3% of muscle mass in COVID-19 patients for an admission less than 10 
days, we hope to recruit 124 patients. A loss to follow-up rate has been estimated 
0%. 
Subjects will be followed up during hospitalization and one month after the time of 
recruitment. The 30-day follow-up will be done by reviewing the history 
clinic, and a telephone contact would be made. 
After signing the Informed Consent, the parameters included in the 
Data Collection Notebook, included in Annex I. 
All examinations will be labeled by a unique code, the history number 
clinic and archived in digital format. 
 
c. Inclusion and exclusion criteria. 
 
Patients who meet the following criteria will be included: 
 
- 
Over 18 years old, men or women. 
 
- 
Main diagnosis is pneumonia due to COVID-19 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
- 
Subjects who, after having received the information on the design, the purposes of the 
project, the possible risks that may arise from it and that in any 
moment they can deny their collaboration, verbally grant their 
consent to participate in the study. 
 
The exclusion criteria to participate in the study are: 
 
- 
Refusal of the patient to participate in the study. 
 
- 
Present a malignant neoplasm in active phase except Ca spino- or 
basal cell in local stage 
 
- 
Clinical situation of agony. 
 
- 
Amputation of limb (s). 
 
d. Origin of the data: 
 
The data will be collected prospectively. 
 
 
 
and. Schedule and expected date of completion: 
 
The study will begin in February 2021 , with an estimated duration of 3 months (1 month 
for application, 1 month for data collection, 1 month for results analysis and 
preparation of articles and / or communications). 
 
and. Sample size: 
 
Patients over 18 years of age who are admitted to the hospital and whose 
primary diagnosis and reason for staying is COVID-19 pneumonia. For a 
95% conﬁdence interval, with a precision level of 3%, an estimated loss in 
about 3% of muscle mass in COVID-19 patients for an admission less than 10 
days, we hope to recruit 124 patients. A loss to follow-up rate has been estimated 
0%. 
Subjects will be followed up during hospitalization and one month after consultation. 
recruitment. The 30-day follow-up will be done by reviewing the history 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
clinic, and a telephone contact will be made. 
 
 
 
 
 
 
 
 
Four. V ARIABLES IN EVALUATION 
 
Data to collect: 
 
* PRIMARY VARIABLE: 
 
to. Variables related to ultrasound: 
 
To collect these variables, the GE VENUE will be used, the linear probe will be used 
(5.5–7.5 MHz) (General Electrics Healthcare, Madrid, Spain). 
 
All patients will undergo a muscle ultrasound upon admission to the center and prior to 
upon discharge, using the usual muscle sweep technique. The ultrasound will be performed on the 
rectus femoris, vastus medialis, vastus lateralis and medial calf muscles. They will be measured: 
 
• Muscle thickness in its cross section (in mm), in the plane of maximum thickness 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
in longitudinal sweep 
 
• Cross-sectional area (in cm 2 ) in the plane of maximum area in the scan 
longitudinal 
 
• Angle of penation (in degrees) of the medial twin, using the base of the 
angle the deep muscle fascia and as an angle the maximum inclination of the 
you muscle mass. 
 
This exam will be carried out by 5 experienced physicians according to the criteria of the 
ACEP (American College of Emergency Physicians) and who carry out more than 10 studies 
ultrasounds per week and at least 3 years of experience in the performance and interpretation 
of ultrasound examinations. A reliability study will not be conducted given the limitation in the 
time and current healthcare pressure. 
 
In addition, to avoid the possible bias that inter-operator variability would suppose in these 
circumstances, the research team was provided with a training program and 
designed internal training consisting of: 
 
- Theoretical course on basic, systematic musculoskeletal ultrasound, 
medication, etc. 
 
 
 
 
- Practical seminars in which an ultrasound machine and healthy models will be used to 
your measurement. 
- Supervised practical training with real hospital patients until assessing 
an adequate measurement of at least 5 patients. 
- The team of 5 doctors adequately trained in this technique were 
speciﬁc to this trial to avoid protocol deviations and any other 
form of interoperator variability. 
 
 
* SECONDARY VARIABLES: 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
to. Demographic variables: 
 
- Age. Sex. 
 
b. Clinical variables: 
 
- Symptoms and time of evolution. 
 
- Usual treatments. 
 
- Previous illnesses. 
 
 
- Barthel scale prior to admission and discharge. 
 
c. Variables related to physical examination: 
 
- Blood pressure (systolic, diastolic), heart rate (HR), respiratory rate 
(FR), oxygen saturation (SO2), Temperature (Tº). 
 
d. Analytical and image variables: 
 
- Upon arrival: blood count (Hb and leukocytes - Neutrophils and Lymphocytes), biochemistry 
(creatinine, urea, CRP, AST, ALT, IL-6) and arterial blood gas (pO2, pCO2, lactate, pH). In 
the pertinent indications, it will be collected if available: Procalcitonin, CK, LDH, 
NT-ProBNP, D-Dimer, Troponin I. 
 
 
 
 
 
 
- Control analysis: Hemoglobin, leukocytes, lymphocytes, Albumin, prealbumin, 
Total proteins, Calcemia, Phosphataemia, Ferritin, Vitamin D, Folic Acid, Vitamin 
B12, Creatinine, Cholesterol, Triglycerides. 
 
- Chest X-ray and / or chest CT. 
 
and. Nutritional Variables: 
 
o Current weight and height : if it cannot be measured, self-reported. 
 
o Recent weight loss 
 
o Measurement of muscle strength , using dynamometry (average of 3 measurements) 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
in dominant arm. 
 
o Circumference of the calf. 
 
o Body composition using impedance measurement (BIA) that estimates the mass 
muscular skeletal muscle. 
o Pass the SARC-F questionnaires , as a universal screening method: 5 
questions in less than 1 minute. 
o Establish criteria for malnutrition ( MUST questionnaire ) and frailty (criteria 
Friend). 
Minnesota Brief Physical Activity Questionnaire 
 
F. Treatment-related variables: 
 
- Treatment according to clinical practice: drug, duration and dose. 
 
g. Variables related to evolution: 
 
- Degree of functional recovery at 30 days (Barthel scale) and quality questionnaire 
life (EuroQol-5D). Adverse events or complications during the next 30 
days of admission. Any event will be considered complications after 30 days 
unexpected event requiring treatment or medical attention, within 30 days of the 
episode (whether hospitalized or not), generally clinical worsening, 
readmission or mortality. 
 
 
 
 
 
 
 
5. 
METHODOLOGY 
 
to. Selection of study cases 
 
Patients over 18 years of age who are admitted to the Hospital and whose 
primary diagnosis is COVID-19 pneumonia. 
 
For this, patients who meet the criteria of 
inclusion. After granting verbal consent, the parameters included in the 
Data Collection Notebook, included in Annex I. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
All examinations will be tagged with a unique code and history number 
Hospital clinic, and archived in digital format. 
 
b. Information collection: 
 
Once the patient has been recruited, the objectives and procedures of the study will be explained, 
He will provide the information sheet and you will be asked for your informed consent. 
 
Then, according to the usual clinical practice, an evaluation will be carried out 
clinic that includes anamnesis, physical examination and extraction of laboratory tests, as well as other 
complementary tests that are considered appropriate for the patient's situation. A) Yes 
Also, at the time of the ﬁrst assessment, a muscle ultrasound of the 
lower limbs, repeating it prior to discharge. All the variables collected will be collected 
in section 4 of this protocol. 
 
The duration of the follow-up will be 30 days, the presence of complications in 
this time, by reviewing the medical history, as well as functional recovery 
(Barthel scale), and will be contacted by telephone, to pass a quality questionnaire of 
life (EuroQol-5D). 
 
Any unexpected event that requires treatment or 
medical care, including mortality. Any undesirable effects will be collected 
observed, during hospitalization, and during follow-up for the next 30 days. 
 
 
 
* The patient's CRF will include: 
 
Demographic variables, physical examination, laboratory ﬁndings, related to the 
diagnosis, treatment, as well as clinical evolution (see Annex I). 
 
* Usual intervention: 
 
According to the usual management of COVID-19 infection, individualizing its use 
at the discretion of the responsible physician. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
It must be taken into account that the use of ultrasound will be carried out according to the 
current international recommendations (detailed below), and that 
strict measures will be followed to avoid contagion, it does not imply under any circumstances 
delay in the administration of treatment. 
 
MECHANISMS TO AVOID CONTAGION 
 
Unlike the description of the ultrasound ﬁndings, the protocol of 
disinfection in the exploration is intended to be maximum, since we would not be 
providing any beneﬁt if we were in this way helping to spread the 
virus. 
 
The contagion probability has been evaluated and compared with the X-ray of 
chest (crowded waiting rooms, patients transferred by relatives who 
can infect, difﬁculty to move), or even in front of a stethoscope 
or pulse oximeter. The ultrasound probe does not have a contact surface greater than 
the stethoscope, and the disinfection measures to be taken with the probe will be 
in any case those marked by the Ministry. 
 
For the patient: mask and gloves, exclusive room isolated from the rest for 
address suspected COVID. At the entrance of the hospital, a person 
awaits patients who come on suspicion, they are provided with a mask 
and gloves. Then they enter the consultation. (Within the usual protocol 
designed by the center) 
 
For personnel: FFP2 mask, PPE, gloves; following the 
recommendations given from Primary / Preventive Care. 
 
 
 
For the ultrasound system (including probe cable): wash ﬁrst with 
enzymatic detergent and then with alcohol 96%; before and after; 
for all ultrasound except the probe. 
 
For the probe: virucidal 99% alcohol-free (Clinell®). 
 
In addition, an ultrasound can optionally be performed covering the probe 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
with a condom, which will be discarded after assessing each patient. The quality of 
the image does not deteriorate and is one more protective measure for the probe, 
 
completely minimizing the risk of contagion; although it is an expense 
extra. 
 
The probe support area on the ultrasound machine will be cleaned with detergent 
enzymatic and alcohol 96%. It will also be covered with a glove, which 
dispose of after each patient in such a way as to avoid as much as possible 
contact between the probe handle and the ultrasound machine. 
 
After each day, the ultrasound machine will also be washed with bleach diluted with water 
(1:50), following the recommendations of the Ministry of Health. 
 
PROCEDURE FOR CLEANING THE MATERIAL 
ECOGRAPHY 
 
The ultrasound machine will be at all times in the consultation reserved for attention to 
suspected COVID. 
 
Before carrying out: hand washing with soap and water. Will wash ﬁrst 
with enzymatic detergent (optional) and then with alcohol 96% all the 
surface of the ultrasound system including cable and ultrasound support area, 
except for the probe. The tube will be cleaned with Clinell®. 
 
During the procedure: the examination will be done with the “dirty” hand in 
contact with the patient avoiding touching the rest of the ultrasound machine to the extent 
the possible. The other hand (“clean”) will be left to handle the ultrasound machine 
(amplitude, gain, zoom, ...). 
 
 
 
 
 
 
 
 
After completion: it will be washed again with 96% alcohol. Washing 
hands. 
 
Wait at least until the ultrasound machine has dried after the 
disinfection procedure before restarting the process. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
c. Practical considerations: 
 
INCLUSION PHASE: 
 
All patients admitted to HEEIZ hospital will be selected. I know 
will verify that they meet the inclusion criteria and none of the exclusion criteria, and they will be informed 
of the objectives and procedures of the study, giving them the information sheet and 
requesting their verbal informed consent. CRF 
COMPLIANCE: 
The diagnostic and therapeutic management of the patient will be carried out according to clinical practice 
usual, ﬁlling in the CRF all demographic variables, physical examination, 
diagnostic, ultrasound and follow-up variables that appear in section 4 of this 
protocol. 
 
FOLLOW-UP OF PATIENTS: 
 
Patients will be followed up to day 30 after inclusion in this study (well, after 
hospital discharge or until the day of death if it occurs before day 30), in order to 
evaluate the main variables. The follow-up will be done by reviewing the 
electronic medical record, and will be contacted by phone. 
ANALYSIS OF RESULTS: 
Once the follow-up of the last patient has been completed, the statistical analysis of 
the results and the ﬁnal study report will be prepared. 
 
FINANCING: 
 
 
 
This is an unfunded study sponsored by researchers. The promoter (Group of 
GTEco-SEMI ultrasound) will provide the necessary material (information, notebook, 
methodology and logistics) to carry out the study. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
d. Schedule: 
The total duration of the project is estimated at 03 months . 
 
FEBRUARY 
MARCH 
APRIL 
APRIL 
 
Authorization request 
• 
by the CEIC and classiﬁcation 
by AEMPS 
Identiﬁcation of 
• 
patients 
Data Collect 
• 
Study database 
• 
 
Statistic analysis 
• 
Elaboration of the report 
• 
ﬁnal 
Table 1. Study development 
 
 
 
and. Statistic analysis 
 
The variables will be expressed by total numbers and percentages for the variables 
categorical, and central values with measures of dispersion (mean and standard deviation / 
median and interquartile range if not normal distribution) for quantitative variables. 
 
For the comparisons, the following statistical tests will be carried out: Chi 2 and obtaining 
of the odds ratio with 95% conﬁdence intervals (for the comparison of variables 
qualitative); Student's t (and Spearman test) (to obtain the difference of means / 
ranges); and Pearson's R (to determine the correlation between the variables 
quantitative). The data will be analyzed using SPSS statistical analysis software. 
20.0. 
 
Data in absentia will not be charged and will be left as lost. 
 
 
 
 
6. 
A SPECTS ETHICAL 
 
to. General and particular rules for researchers. 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
Researchers will strictly adhere to the provisions of this protocol and the 
good clinical practice, fully completing the data collection sheets. 
 
Following the guidelines of the center, the study will be evaluated by the Ethics Committee of the 
Research with drugs from the San Carlos Clinical University Hospital. The current revision 
of the Helsinki declaration is the accepted basis for ethics in human research, and 
must be scrupulously followed and respected by all persons involved in said 
research. 
 
b. Informed consent. 
 
All patients will be informed, before starting the study, of the objectives, procedures and 
discomforts and risks of the study according to a speciﬁc information sheet. Blade 
Informed consent information appears in the annex to this protocol. 
 
c. Beneﬁt-risk assessment for research subjects: 
 
As it is a study that does not modify healthcare practice, it does not imply any added risk 
for patients. Ultrasound is a harmless technique, it requires the application of a gel 
water-soluble conductor, and can cause minor discomfort such as pain from the pressure exerted, 
 
redness or a small bruise. 
 
d. Security and conﬁdentiality devices. 
 
The information disseminated and obtained by the implementation of this study is considered 
conﬁdential and should be treated as such at all times. 
 
Only the investigators will know the data (patient initials and history number) that 
can identify patients. Initials and patient record number will be separated 
of the rest of the notebook, and will not be entered in the study database. The patient will be 
identiﬁed by a numerical code in order to respect the conﬁdentiality of the 
Personal data of patients, as established by Organic Law 3/2018, of December 5, of 
Protection of Personal Data and guarantee of digital rights. The collection and management of 
samples will follow the indications established in Law 14/2007, of July 3, on research 
biomedical. 
 
 
 
In order to guarantee the conﬁdentiality of the study data, they will only have access to the 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
The researcher and his team of collaborators, the Ethics Committee for Clinical Research, the 
relevant health authorities and the promoter's representatives. 
 
The researcher agrees to collect, record and report the data in a reliable way and 
correct, responding to its updating and quality before the appropriate audits. 
 
Patients will be identiﬁed by a number, both in the e-CRF and in the database. I know 
will guarantee the total conﬁdentiality of the data, in particular the identity of the participants. 
 
The data of the researchers and the study will be entered and processed in a proprietary ﬁle 
of PROMOTOR that will be responsible for the ﬁle before the Spanish Agency for Data Protection 
(AEPD). It will be ensured that they will be treated in accordance with the provisions of the Protection Law 
of Personal Data, exclusively for the development and good end of the study. 
 
When personal data belonging to the Researcher and / or patients is archived or processed, 
The Promoter will take the appropriate measures to protect and prevent access to this data, for 
part of unauthorized third parties. 
 
Any data required by the protocol may be subject to audits by the promoter, 
independent organizations and / or competent authorities, but the conﬁdentiality of the data 
it will always be an indispensable condition. 
 
and. Interference with the doctor's prescription habits. 
 
In no case will the study interfere with the care tasks, nor will it modify 
the doctor's prescription habits. 
F. Pertinence of exploration by IP 
The IP is certiﬁed for the performance of Clinical Ultrasound by WINFOCUS and SEMES, SEMI, 
in addition to having the Certiﬁcation in Echocardioscopy by SEMI-SEC, which justiﬁes its 
aptitude to carry out this research project. 
 
 
 
 
 
 
 
 

 
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7. 
BIBLIOGRAPHY 
 
 
 
1. Rosenberg I. Summary comments: epidemiological and methodological problems in 
determining nutritional status of older persons. Am J Clin Nutr 1989; 50: 1231-1233. 
2. Von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers 
on prevalence and clinical impact. J Cachex Sarcopenia Muscle. 2010; 1: 129-33. 
3. Alfonso J. Cruz-Jentoft, Jean Pierre Baeyens, Jürgen M. Bauer, Yves Boirie, Tommy 
Cederholm, Francesco Landi, et al. Sarcopenia: European consensus on deﬁnition and 
diagnosis. Report of the European Working Group on Sarcopenia in Older People. Age and 
Aging 2010; 39: 412-423. 
4. Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, et al. 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; 
12: 249–256. 
5. 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; 69: 547-558. 
6. 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; 8: 702-712. 
7. Welch C, Greig C, Masud T, Wilson D, Jackson TA. COVID-19 and Acute Sarcopenia. 
Aging Dis . 2020; 11 (6): 1345-1351. Published 2020 Dec 1. doi: 10.14336 / AD.2020.1014 
 
8. Welch C, Hassan-Smith Z, A Greig C, M Lord J, A Jackson T. Acute Sarcopenia 
Secondary to Hospitalization - An Emerging Condition Affecting Older Adults. Aging Dis . 
2018; 9 (1): 151-164. Published 2018 Feb 1. doi: 10.14336 / AD.2017.0315 
9. Dirks ML, Wall BT, van de Valk B, Holloway TM, Holloway GP, Chabowski A, 
Goossens GH, van Loon LJ. One Week of Bed Rest Leads to Substantial Muscle Atrophy 
and Induces Whole-Body Insulin Resistance in the Absence of Skeletal Muscle Lipid 
Accumulation. Diabetes. 2016 Oct; 65 (10): 2862-75. doi: 10.2337 / db15-1661. Epub 2016 Jun 
29. 
 
 
 
 
 
 
 
 
 
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ANNEX I: 
 
DATA COLLECTION NOTEBOOK 
 
 
 
 
 
 
 
 
 
 
 
CRF SARCO-COVID: Measurement of Skeletal Muscle Loss 
in hospitalized patients diagnosed with COVID-19 
 
PATIENT ID 
AGE AND SEX 
Comorbidity 
CARDIOP 
MY AUNT? 
 
 
PERSONAL PREVIOUS ETV 
OR FAMILY? 
 
 
HTA / DM 
? 
 
 
AUNT? 
 
NEUMOPA 
IRC? 
IMMUNOSUPPRESSION? 
Obesity? 
Others? 
 
Usual treatment 
 
 
Main symptoms and 
time of evolution 
 DYSPNOEA 
OTHERWISE 
 
FEVER 
OTHERWISE 
 
ASTENIA / MIALGIAS 
OTHERWISE 
 
 
DIARRHEA / NAUSEA 
OTHERWISE 
 
COUGH 
OTHERWISE 
 
PAIN 
THORACIC 
OTHERWISE 
WEIGHT LOSS> 5% 
IN 3 MONTHS 
OTHERWISE 
 
TA 
FC 
SO2 
FR 
Tº 
Weight (kg) 

 
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Size (cm) 
  
 
Circumference 
waist 
Dynamometry B. 
dominant (mean of 
3) 
Weight loss> 
Circumference 
calf 
 
TBW: total body 
toilet 
Bioimpedanceometry  
MM: muscular 
mass 
FFM: fat free mass 
FM: fat masS 
BCM: body cell mass 
 
Hb 
Leucos (Nt, L) 
Creatinine 
Urea 
AST 
ALT 
LDH 
Lactate 
pO2 
pCO2 
pH 
CK 
D-dimer 
procalcitonin 
PCR 
Troponin I 
Nt Pro-BNP 
IL-6 / Ferritin 
 
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Page 27 
 
 
 
 
Albumin 
Prealbumin 
Total proteins 
Calcemia 
Phosphataemia 
Vitamin D 
Folic acid 
B12 vitamin 
Cholesterol 
Triglycerides 
 
FEMORAL STRAIGHT D 
ENTRY 
INTERNAL VAST D AL 
ENTRY 
EXTERNAL VAST D AL 
ENTRY 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Thickness 
maximum 
(mm) 
Sectional area 
(cm2) 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
 
 
 
FEMORAL STRAIGHT I TO 
HIGH 
INTERNAL VAST I TO 
HIGH 
EXTERNAL VAST I TO 
HIGH 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Thickness 
maximum 
(mm) 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Thickness 
maximum (mm) 
 
 
 
 
 
INTERNAL TWIN D AT INCOME 
INTERNAL TWIN I ON ADMISSION 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Angle of 
Penalty (in 
degrees) 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Angle of 
Penalty (in 
degrees) 
 
 
 
INTERNAL TWIN D ALTA 
INTERNAL TWIN I ALTA 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Thickness 
maximum 
(mm) 
Thickness 
maximum (mm) 
Sectional area 
(cm2) 
Thickness 
maximum (mm) 
 
 
 
 
 
ATB 
Anti-IL 6 
Corticosteroids (days and 
max dose) 
Corticosteroid bolus 
(dose and days) 
Anticoagulant 
 
O2 
(modality) 
NIMV 
VM 
You go amines. 
ECMO 
 
 
BARTHEL PREVIOUS 
ON ENTRY 
(date) 
WORST BARTHEL 
DURING ADMISSION 
(date) 
BARTHEL AL 
HIGH 
(date) 
BARTHEL AL 
MONTH OF 
RECLUT. (date) 
 
 
 
SARC-F 
MUST 
FRAGILITY 
MINNESOTA 
 
 
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Loss Follow-up Mortality 
Adverse Event (description) 
 
 
 
 
 
 
 
MINNESOTA REDUCED 
 
 
 
 
 
 
 
FRIED AND WALSTSON CRITERIA 
 
 
 
 
 
 
 
 
 
 
 
 
DYNAMOMETRY

 
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MIR / HEEIZ_2021_03 protocol 
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Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANNEX II: 
 
COMMITMENT OF CONFIDENTIALITY OF THE INVESTIGATORS TO THE CEIC 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
 
 
 
 
 
 
COMMITMENT OF THE INVESTIGATORS 
AND CONFIDENTIALITY 
 
 
 
Dr. Yale Tung Chen and Dr. Marcos Fragiel Saavedra. 
Principal investigator. 
Principal Co-Investigator 
University Hospital of Emergencies Nurse Isabel Zendal. 
AV. Manuel Fraga Iribarne, 2, 28055 Madrid 
 
 
 
It states: 
 
• Who know and agree to participate as principal investigators in the study 
titled: " SARCO-COVID: Measurement of Skeletal Muscle Loss 
in the hospitalized patient diagnosed with COVID-19 " 
• That they undertake that each subject is treated and controlled following the 
established in the protocol approved by the Research Ethics Committee. 
• That it will respect the ethical requirements and standards applicable to this type of study 
• That they undertake to maintain strict conﬁdentiality of the data of 
personal character from the source. 
• That the results obtained from the study may be disclosed in Congresses, 
scientiﬁc meetings and publications, always safeguarding the conﬁdentiality of 
personal data. 
 
 
 
 
In Madrid to 27 of January 2021 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
Dr. Yale Tung Chen 
Dr. Marcos Fragiel Saavedra 
 
Principal investigator 
Principal Co-Investigator 
 
 
 
 
 
 
ANNEX III: INFORMATION SHEET AND INFORMED CONSENT 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
 
 
 
INFORMATION SHEET AND INFORMED CONSENT 
 
 
Study Title: SARCO-COVID: Measurement of Muscle Loss 
skeletal structure in hospitalized patients diagnosed with COVID-19 
 
PROMOTER: Working Group on Ultrasound of the Spanish Society of Medicine 
Internal 
PRINCIPAL RESEARCHERS: Dr. Yale Tung Chen and Marcos Fragiel 
Saavedra 
CENTER: Hospital de Emergencias Nurse Isabel Zendal. 
 
 
 
INTRODUCTION 
 
We are writing to you to inform you about a research study in the 
that you are invited to participate. The study has been approved by the Ethics Committee of 
Clinical Research of the Hospital de Emergencias Nurse Isabel Zendal. 
 
Our intention is only that you receive the correct information and 
enough for you to evaluate and judge whether or not you want to participate in this study. For 
Please read this information sheet carefully and we will clarify any doubts you may have. 
may arise after explanation. In addition, you can consult with the people who 
consider appropriate. 
 
BACKGROUND AND OBJECTIVES 
 
On March 11, the World Health Organization (WHO) declared the 
state of “global pandemic” caused by coronavirus 2, when Asia was already 
infected and in Europe the situation began to unleash. 
 
The spread of COVID-19 began around 11 months ago and today 
you could say that it already covers the entire planet. At the beginning of 2020, the different 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
Health alerts warned of a highly contagious disease that caused 
very disparate pictures, aggravated by previous comorbidities and becoming 
life-threatening in situations of immunodeﬁciency and serious pathologies 
pre-existing. 
 
Patients suffering from this disease are at risk, both for the 
disease, as by the treatment that is prescribed, they have an increased risk of suffering 
loss of muscle mass, although we still do not know quantitatively the impact 
that has this process. 
 
 
 
 
 
Clinical ultrasound is an imaging test performed by the doctor 
responsible for your care, which provides us with information about the state of your muscles 
and your muscle mass. As for risks, this is a safe use-based test 
ultrasound that have not shown harmful effects in humans. 
 
 
VOLUNTARY PARTICIPATION 
 
You should know that your participation in this study is voluntary and that you can decide 
not participate or change your decision and withdraw consent at any time without 
that this entails negative consequences for you in your future care relationship. 
 
GENERAL DESCRIPTION OF THE STUDY 
 
124 patients with coronavirus pneumonia will participate in the study 
(COVID-19), of both sexes and of legal age, who enter this center. 
 
If you decide to participate, in addition to treatment, imaging tests or 
blood samples that are drawn in routine clinical practice for diagnostic and 
therapeutic treatments, a muscle ultrasound will be performed. 
 
The study consists of performing muscle ultrasounds to patients in 
the internal medicine service. The development of the test will last 5 
minutes approximately and we will need access to the clinical data of the 
study participants to complete the outcome assessment. 
 
A muscle ultrasound of the lower limbs will be performed upon admission and 
prior to discharge, by the investigating physicians, including an assessment 
muscle of the lower extremities. Within a month of your admission, it could be 
contacted by telephone by the research team to make some brief 
questions about your condition. 
 
In addition, a nutritional assessment will be performed by a team of 
endocrinologists of the center, with 3 questionnaires to know their level of physical activity, 
frailty and malnutrition. It will be done as part of this assessment: weight, height, 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
measurement of muscle strength, measurement of calf circumference and a 
measurement of body composition by impedance measurement (estimates the 
muscular body composition by means of a pair of electrodes which are connected to 
a machine that processes information) 
 
It will not delay or modify in any case the treatment to be received. 
 
All the procedures that will be performed will be the usual ones for the 
diagnosis and treatment of your COVID-19 infection. 
 
 
 
 
BENEFITS AND RISKS DERIVED FROM YOUR PARTICIPATION IN THE 
STUDY 
 
You will not have any health beneﬁts from participating in this study. 
 
Ultrasound is a harmless technique, it requires the application of a gel 
water-soluble conductor, and may cause minor discomfort such as pressure pain 
exerted, redness or a small bruise. 
 
If you have questions or need clariﬁcation about these terms or expressions 
do not hesitate to consult with the members of the research team. 
 
PUBLICATION OF RESULTS 
 
The results of the study will be made public, according to one of the channels 
accepted by the scientiﬁc community, maintaining in any case the conﬁdentiality and 
right of the participants. 
 
CONFIDENTIALITY 
 
The treatment, communication and transfer of personal data of 
All participating subjects will comply with the provisions of Regulation (EU) 
2016/679 of the European Parliament and of the Council of April 27, 2016 Protection 
Data (RGPD). 
Both the Center and the Promoter are responsible respectively for the 
processing of your data and undertake to comply with the protection regulations of 
data in force. The Research Ethics Committees, the representatives of the 
Health Authority in inspection matters and the personnel authorized by the Promoter, 
They can only access to verify personal data, procedures of the 
clinical study and compliance with the rules of good clinical practice (always 
maintaining the conﬁdentiality of the information). 
In accordance with the provisions of the aforementioned legislation, you can exercise the 

 
Protocol MIR/HEEIZ_2021_03                                      Version 2.0. February 2021 
 
 
ryioguhtsshoofualdccteaslks,troecytoiﬁurcastuodny, odpopctoosri.tiIonnaadndditidoenlettoiotnheorfiygohutsr ydoautaa, lfroeradwyhkicnhow 
(access, modiﬁcation, opposition and cancellation of data) can now also limit the 
treatment of data that are incorrect, request a copy or transfer to a 
third (portability) the data that you have provided for the study. To exercise your 
rights, contact the study principal investigator Dr. Yale Tung Chen or the 
Delegate of Data Protection of the Jose Manuel Laperal González center [tel. 
91426998 / e-mail: protecciondedatos.sanidad@madrid.org] 
We remind you that the data cannot be deleted even if you stop participating in 
the trial to ensure the validity of the research and comply with legal duties 
and drug authorization requirements. You also have the right to address 
the Data Protection Agency if you are not satisﬁed. 
Both the center and the Promoter are responsible respectively for the 
processing of your data and undertake to comply with the protection regulations of 
data in force. The data collected for the study will be identiﬁed by means of a 
code, so that information that can identify you is not included, and only your 
 
study doctor / collaborators may relate said data to you and your 
clinic history. Therefore, your identity will not be revealed to anyone except to 
health authorities, when required or in cases of medical emergency. The 
Research Ethics Committees, representatives of the Health Authority in 
inspection matter and the personnel authorized by the Promoter, may only 
access to verify personal data, clinical study procedures and the 
compliance with the rules of good clinical practice (always maintaining the 
conﬁdentiality of information). 
The Researcher and the Promoter are obliged to keep the data collected 
for the study at least up to 25 years after completion. Subsequently, his 
Personal information will only be kept by the center for the care of your health and by 
the sponsor for other scientiﬁc research purposes if you had granted your 
consent to do so, and if permitted by law and applicable ethical requirements. 
If we transfer your encrypted data outside the EU to the 
entities of our group, service providers or scientiﬁc researchers who 
collaborate with us, the participant's data will be protected with safeguards 
such as contracts or other mechanisms by the data protection authorities. 
 
 
QUESTIONS AND INFORMATION 
 
In case of doubts about the study or your rights, you can contact Dr. 
Yale Tung Chen or any of the doctors on the research team at the 
Telephone number of the doctor responsible for the HEEIZ (651.630.523), available 24 hours a day. 
 
 
Volunteer signature: 
For the research team: 
 
 
Name: 
Name: 
Date: 
Date: