Design: 1) prospective study in SARS-CoV-2 infected patients admitted to the CSdM more than
48h with 2 follow-up points at 3/6 months after discharge.

2) comparative study between the 3 first waves of the pandemic in the acute phase.

Aims:

1.1)To assess the prevalence of OD, nutritional risk, the needs of compensatory treatment and
complications at 3/6 month follow up of patients admitted by COVID-19 in Hospital de Mataró,
Hospital St. Jaume and the medicalized Atenea Hotel, Mataró (Barcelona), Spain.

1.2)To validate an early intervention including fluid thickening and nutritional support.

1.3)In addition, we would like to know if those patients with OD and those with OD and MN
have worse prognosis than those without these conditions.

2.1) To compare the three first waves of the pandemic in the hospitalization period
(clinical, swallowing, nutritional status and mortality).

- Inclusion criteria: Infected patients (COVID-19 + PCR or according to physician's
criteria at discharge medical report) admitted to the CSdM >48h; patients able to be
explored regarding OD and nutritional status according to their physician's criteria
(fully awake patients in a stable respiratory situation and optimal PaO2/FiO2).

- Exclusion criteria: uncontrolled risk of infection for healthcare professionals (HCP).

Study population

All COVID-19 patients admitted to the CSdM more than 48h from April to the end of the
pandemic:

1. ICU. Patients in/post ICU with OD associated with intubation/mechanical ventilation or
OD associated with tracheotomies or NG tubes (semi-critical patients).

2. Wards. Patients with respiratory infection/pneumonia/respiratory insufficiency, some of
them with a severe disease needing high concentration of oxygen or noninvasive
mechanical ventilation (acute patients with some complexity).

3. Post-acute COVID-19 patients discharged from acute hospitals to rehabilitation centers,
nursing homes or medicalized facilities (sub-acute patients, convalescents).

Sample size calculation: Taking into account the main study variable and that we will do an
opportunistic recruitment (admitted patients), a sample size of 315 subjects randomly
selected will suffice to estimate with a 95% confidence and a precision +/-5.5 percent units,
a population percentage considered to be around 55.0% (estimated OD prevalence). It has been
anticipated a replacement rate of 0%.

Study variables

- Main variable: prevalence of OD and risk of malnutrition among COVID-19 patients.

- Secondary variables: needs of nutritional supplementation, texture-modified diets, use
of thickeners and patient's adherence to compensatory measures, functional capacity,
comorbidities, nutritional analytical parameters, weight, clinical severity (including
pneumonia severity), neurological symptoms, pharmacological treatment, ICU admission,
and hospital readmissions, visits to emergency department, respiratory infections and
mortality at 3 and 6 months follow-up. Clinical prognosis in those patients with OD
and/or MN compared to those without these conditions.

Study visits/evaluations/management 4 evaluation points*: 1) admission; 2) discharge; and
3-4) follow up at 3 months and 6 months. According to the first evaluation, an interventional
plan (management) will be prescribed in order to improve patient's swallowing, feeding and
nutritional status during admission. All the evaluations and interventional plans are
currently being performed as standard clinical practice and will be obtained from patient's
medical history record. Study variables will be grouped in 3 different assessments: a)
clinical assessment; b) swallowing assessment; and c) nutritional assessment.

* There will be no follow-up in the comparative study between the 3 firsts waves of the
pandemic.

1. Admission*: there will be 2 admission evaluation points, the first one 24-48h after
admission (pre-admission data) and the second one during admission (admission data).

1.1.Clinical evaluation: patient origin (community, nursing home, socio-health center),
functional status before, during admission and at discharge (Barthel index),
comorbidities (Charlson index), clinical symptoms before and during admission,
neurological symptoms, ICU admission and length of stay, respiratory infection, its
symptoms, severity and length from the week before admission, prescribed pharmacological
treatment, hospitalization days and mortality during admission.

1.2.Swallowing evaluation: anamnesis, EAT-10 questionnaire (screening), clinical
swallowing assessment with volume-viscosity swallowing test (V-VST) at admission and
tolerance and adherence with the recommendations (volume and viscosity) during
admission.

1.3.Nutritional evaluation: anthropometrical measurements and nutrition-related
questions pre and post-admission, analytical parameters at admission and during
admission (albumin, pre-albumin, cholesterol, total proteins, lymphocytes, ferritin and
C-reactive protein), NRS2002 at admission and at discharge and nutritional
recommendations during admission (ONS, type of diet and intake) and patient's adherence.

2. Discharge:

2.1.Codification at discharge: SARS-CoV2 pneumonia, OD, respiratory infection,
aspiration pneumonia, malnutrition or others.

2.2.Recommendations at discharge: fluid and nutritional recommendations at discharge
(volume and viscosity, oral nutritional supplementation and type of diet).

*After evaluations, healthcare professionals will give to the patients clinical
recommendations on the use of thickeners, texture-modified diets and nutritional
supplementation if required.

3. Follow up (3/6 months): we will collect clinical data, information about swallowing and
nutritional status and needs through the electronical medical history of the patients
and by telephone call. Patients will receive new recommendations on fluid and
nutritional adaptation and nutritional supplementation if required. The follow-up
evaluations will include:

3.1.Clinical evaluation: mortality (date), patient residence (community, nursing home,
socio-health center), functional status (Barthel index), and hospital resources
consumption/clinical outcomes (hospital readmissions, visits to the emergency department, and
respiratory infections).

3.2.Swallowing evaluation: anamnesis, EAT-10 (swallowing screening); if positive, virtual
clinical swallowing assessment with the V-VST, and fluid adaptation recommendations.

3.3.Nutritional evaluation: anthropometrical measurements (current weight), ONS intake (time
taken from discharge), textural diet adaptation if needed and compliance with the previous
recommendations, NRS2002, and analytical parameters (albumin, cholesterol, ferritin,
C-reactive protein) if the patient had a blood analysis during the previous month.

Management of patients with COVID-19, OD and MN:

After admission in our health care centers, COVID-19 patients will be screened by a speech
and language pathologist (SLP) for OD with specific questions and the V-VST, and nutritional
status with the NRS2002. In addition, clinical data of patients will be recorded during
admission. Those patients with a NRS2002 ≥ 3 points, will require ONS, that will be given in
two formats (liquid or viscosity-adapted) depending on the swallowing status. Those patients
with less than 70 years will receive 2 instead of 1/day. According to patient's masticatory
and swallowing hability they will receive texture-modified diets in 3 different formats: 1)
normal, 2) easy mastication diet, and 3) puree. Normal diet is composed by 1750Kcal/70g
protein; if the patient is at nutritional risk or malnourished (NRS2002≥3) he/she will also
receive a high caloric-proteic diet with 2000Kcal/90g protein. Finally there will be a fluid
adaptation according to the results of the V-VST with 3 different viscosities: 1)liquid,
2)250mPa•s, and 3)800mPa•s. During admission patients will be managed by the SLPs and the
nutritionist team of the healthcare centers. Just before discharge, patients will be
re-evaluated and swallowing and nutritional recommendations will be given adapted to the new
status of the patient by using the same criteria. On a nutritional level, just before
discharge, patients will be re-evaluated by the team of dietitians to detect those patients
who have not yet improved their nutritional status and therefore will need to continue taking
ONS after discharge. The criteria for maintaining or not maintaining the prescription at
discharge will be those corresponding to a normal dietary assessment, such as: anorexia, not
having recovered weight or insufficient intake due to vomiting, nausea or other causes not
related to hospital food. Other criteria may be included at the discretion of the clinical
professional. This group will be dispensed ONS for at least 1 month after discharge.

We will collect also data on patient's destination, functional capacity, weight loss,
admission to the ICU and clinical data at discharge. Finally, patients will be followed-up at
3/6 months for clinical complications through their electronic medical history.

Main study procedures and variables

- EAT-10: is a simple 10-item questionnaire to screen for the risk of dysphagia (score>2,
risk of OD) (Belafsky P 2008, Ann Otol Rhinol Laryngol; Rofes L 2014, Neurogastroenterol
Motil).

- V-VST: is a validated clinical test to explore safety and efficacy of swallow and select
the optimal bolus volume and viscosity for each patient with/at risk of OD. It uses
different volumes (5, 10 and 20mL) and viscosities (250mPa•s, liquid and 800mPa•s)
(thickener Nutilis Clear) to evaluate clinical signs of impaired efficacy and safety of
swallow. We will apply a simplified V-VST with only 1 volume (10mL) and the 3 usual
viscosities in order to reduce the hospital burden and stress for the patient (Clavé P
2008, Clin Nutr). Recommendations on fluid adaptation given to the patient according to
the results of the test will be recorded.

- Nutritional status: a nutritional evaluation is done to COVID-19 patients according to
their phenotype. We will use the nutritional risk screening (NRS 2002), a validated
nutritional screening tool for hospitalized adult patients and has been recommended by a
recent guideline for COVID-19 admitted patients (Ying-Hui Jin, 2020, Mil Med Res). If
the patient scores 3 or more points is considered to be in nutritional risk and a more
comprehensive nutritional evaluation should be performed and nutritional supplementation
applied. Recommendations on nutritional adaptation given to the patient (adaptation of
texture/calories/proteins and nutritional supplementation) according to the results of
the tests will be recorded.

- Other study variables collected from patient's medical history: patient origin and
destination at discharge, hospitalization days, admission to the ICU, myopathy post-ICU
and length of stay in the ICU, symptomatology before and during admission (fever, cough,
dyspnea, diarrhea, vomiting, ageusia, anosmia, headache, polymyalgia), neurological
symptoms during admission (seizures, encephalitis, delirium, headache, dyskinesia,
stroke, parenthesis, ataxia, encephalitis), functionality with the Barthel index
(pre-admission, admission and discharge), comorbidities with the Charlson score,
respiratory infections during admission and its severity and type, use of oxygen
therapy, pronation, prescribed treatment, anthropometric measurements (weight at
discharge, weight loss), use and tolerability of oral nutritional supplements,
nutritional intake, use of enteral or parenteral nutrition, biochemical parameters at
admission and discharge (pre-albumin, albumin, cholesterol, total proteins, lymphocytes,
ferritin and C-reactive protein), diagnostics at discharge (SARS-CoV2 pneumonia, OD,
respiratory infection, aspiration pneumonia, malnutrition or others), and intra-hospital
mortality.

- Follow-up (3 and 6 months): we will collect data of clinical complications from the
medical history of the patient and by telephone call: swallowing, nutritional status and
needs (including analytical parameters), hospital readmissions, visits to the emergency
department, incidence of respiratory infections (including pneumonia, COPD
exacerbations) and mortality.