Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III

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.

Conditions

• COVID19
• Diabetes Mellitus
• Hypertension
• Obesity
• Overweight
• Oxygen Saturation
• Mortality
• Inflammation

Interventions

DIETARY_SUPPLEMENT

Nutritional support system (NSS)

1. 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. 2. Probiotics Saccharomyces boulardii CNCM I-745 "Floratil". One morning and one evening 250 mg capsule during the first 6 days 3. 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.

Sponsors & Collaborators

• Anahuac University

  lead OTHER

Principal Investigators

• Fernado Leal Martínez, Ph.D · Anahuac University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

30 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-07

Primary Completion

2021-04-10

Completion

2021-04-10

Countries

• Mexico

Study Locations