The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and complications depend on the immune capacity of the host. The virus has been characterized by presenting an inflammatory cascade, increased by the overproduction of proinflammatory cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are several lines of treatment, however, nutritional treatment only considered a caloric intake. For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by nutritional support system and the effect of this therapy in reducing complications and comorbidities. Research question: Will the nutritional support system reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM, SAH, overweight / obesity with BMI
Patients in the COVID-19 area, who are treated at the ISSEMYM Toluca Arturo Montiel Rojas
Medical Center, located in Paseo Tollocan, Av. Baja Velocidad km 575, Barrio de Sta Clara,
Toluca de Lerdo, México; both sexes, with the presence of comorbidities (type 2 DM, SAH,
overweight or obesity BMI <35) and in stage III of the disease.
Consecutive cases. With systematic randomized allocation using a sequence of random numbers
built with the Excel program divided into two groups. Once the participants of the COVID-19
area have been selected, patients and / or family members will be spoken to to explain the
protocol and obtain the signatures of the letters of informed consent. Assignment to the
research group will be carried out randomly.
Once the patients have been admitted to the study, the following will be carried out: test of
COVID-19 by means of PCR, thorax tomography, complete clinical history, Mini Nutritional
Assessment (MNA), food diary, list of clinical variables designed by us, complete blood
count, coagulation profile, serum electrolytes, blood chemistry (6-elements), lipidic
profile, liver function tests, ferritin, fibrinogen, C-reactive protein, procalcitonin and
D-dimer. Anthropometric measurements will also be carried out (height, weight, BMI, muscle
mass %, fat % and visceral fat%).
The follow-up will be carried out daily for 21 days or earlier, if they are discharged from
the hospital due to improvement in the evolution, at that moment the patient concludes the
study. The following points will be supervised, recording the information in files and
photos, since the hospital security protocol does not allow to extract stationery from the
COVID-19 area:
1. Application and consumption of NSS supplementation as appropriate.
2. Morning and evening vital signs.
3. Daily clinical evaluation (It includes variables such as oxygen flow, activity level,
integrity of the hair, skin and nails, evaluation of the sense of taste and smell, pain,
gastrointestinal symptoms, bowel movements, prescribed medications, mood, among others).
4. Anthropometric measurements using a scale every 2 days (only if the patient is stable
and can maintain balance).
5. Food diaries of each patient.
6. Laboratory studies every 3 days (previously mentioned).
In the same way, the following will be taken into account: the number of days hospitalized,
number of patients who progress to ventilation, number of patients who die, number of
patients who are extubated and number of days after extubation.
A descriptive analysis will be carried out for each continuous variable. These variables will
be expressed as mean ± standard deviation and standard error. It will be done according to
the distribution of the data; For independent groups with a normal distribution, Student's T
will be applied. If the distribution does not meet normality criteria, a Mann Whitney U will
be performed; For the follow-up of dependent groups with normal distribution, two-way ANOVA
will be applied. If the distribution does not meet normality criteria, a Friedman test will
be performed, in both cases post hoc tests will be performed, taking into account that a
significant value of p of < 0.05. The results will be analyzed using version 6 of the
Graphpad Prism software.
Dietary Supplement: Nutritional support system (NSS)
Combination of three B vitamins (B1, B6 and B12) "Neurobion" 10 mg solution for IM injection, One every 24 hours for the first 5 days.
Probiotics Saccharomyces boulardii CNCM I-745 "Floratil". One morning and one evening 250 mg capsule during the first 6 days
One envelope of NSS-1 in the morning and one envelope in the afternoon mixed with 400 ml of water each, contain nutritional support system.
Other: Conventional nutritional support designed by hospital nutritionists
Diet designed by the nutrition department according to comorbidities and intubation probability. Food will be established according to the provisions of the ISSEMYM Toluca Arturo Montiel Rojas Medical Center.
Inclusion Criteria:
- Patients admitted to the ISSEMYM Toluca Medical Center "Arturo Montiel Rojas ",
diagnosed with COVID-19 confirmed by PCR.
- Patients in need of supplemental O2 with nasal prongs or reservoir-mask for satO2 <90%
and respiratory distress.
- With concomitant diseases such as cardiovascular disease, diabetes mellitus 2,
hypertension, overweight or obesity BMI <35.
- Both sexes.
- Over 30 years old.
- The patient tolerate oral feeding.
- Signing of the letter of informed consent.
Exclusion Criteria:
- Detachment from treatment.
- Admission to the ICU for any reason.
- Patients who do not tolerate the oral route.
- Reactions to treatment that compromise the health of patients.
ISSEMYM "Arturo Montiel Rojas" Medical Center
Toluca de Lerdo, Mexico State, Mexico
Fernado Leal Martínez, Ph.D, Principal Investigator
Anahuac University