Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
Condition: COVID19; Diabetes Mellitus; Hypertension; Obesity; Overweight; Oxygen Saturation; Mortality; Inflammation
MeSH terms: COVID-19; Overweight; Inflammation
Study type: Interventional

Summary: 
      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
      <35), with a better benefit than that achieved with the conventional nutritional treatment ?.

      Hypothesis: The nutritional support system will reduce the complications of patients with
      COVID-19 in stage III with comorbidities. General Objective: To determine the effect of the
      use of a nutritional support system on complications in patients with COVID-19 in stage III
      with comorbidities.

      Methodology: A controlled, blinded, randomized clinical trial will be conducted in patients
      with COVID-19, hospitalized at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, who
      meet the inclusion criteria. The evolution of the group of patients receiving the nutritional
      support system (NSS) and the normal diet implemented by the hospital will be evaluated
      against the group of patients receiving only the diet, using clinical examination, laboratory
      and cabinet tests during their hospital stay.

      Statistical analysis: for independent groups with normal distribution, Student's T will be
      applied. If the distribution does not meet normality criteria, a Mann Whitney U will be
      performed; Two-way ANOVA will be applied to monitor the groups over time with normal
      distribution. If the distribution does not meet normality criteria, a Friedman test will be
      performed, in both cases post hoc tests will be performed. The results will be analyzed using
      version 6 of the Graphpad Prism software.
    

Detailed description: 
      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.
    

Intervention name(s): Nutritional support system (NSS); Conventional nutritional support designed by hospital nutritionists
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: exploratory study, it is a controlled, blinded, randomized clinical trial design.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID19; Nutritional support; SARS-COV-2; Pneumonia; Supplementation; Probiotics