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

October 13, 2021 updated by: Fernando Leal-Martinez, Anahuac University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico State
      • Toluca de Lerdo, Mexico State, Mexico, 52140
        • ISSEMYM "Arturo Montiel Rojas" Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control group
Patients who received the standard diet
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.
Experimental: Intervention group
Patients who received the nutritional support system (NSS) and the standard diet
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 40 days.
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
40 days.
Overall Mortality at Day 40
Time Frame: 40 days.
Total number of patients who died before day 40 of follow-up.
40 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival in Intubated Patients at Day 40
Time Frame: 40 days
Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up
40 days
Mortality in Intubated Patients at Day 40
Time Frame: 40 days
Patients who were intubated during their hospital stay and died before completing follow-up on day 40.
40 days
Progression to Mechanical Ventilation Assistance
Time Frame: 10 days.
total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.
10 days.
Participants With Normal Bristol Scale at Day 3
Time Frame: day 3
The Bristol Stool Form Scale categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhea). Type 3 and 4 were considered "Normal".
day 3
Hidric Balance on Day 3
Time Frame: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
The ratio between the water assimilated into the body and that lost from the body, in milliliters.
It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Oxigen Saturation >90% on Day 3
Time Frame: day 3.
the total number of patients with oxygen saturation >90% on day 3 of their hospital stay.
day 3.
PHQ-9 Test
Time Frame: baseline and hospital discharge
Is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders, includes 9 items, which evaluate the presence of depressive symptoms based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders version 4, during the last 2 weeks, how often the patient presented depressive symptoms. According to the sum of the score obtained, the following 4 categories will be considered: 0-4 minimum existence or absence of depressive symptoms; 5-9 = mild depressive symptoms; 10-14 = moderate depressive symptoms; 15-19 = moderate to severe depressive symptoms; 20-27 = severe depressive symptoms.
baseline and hospital discharge
Oxigen Flow (Intragroup)
Time Frame: baseline and day 3
Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
baseline and day 3
qSOFA at Day 3
Time Frame: Baseline and Day 3
Quick-Sequential Organ Failure Assessment (qSOFA) score gives 0 to 3 points. ≥2 in the setting of suspected infection had a high predicted in-hospital mortality rate and could be considered septic.
Baseline and Day 3
Number of Defectations on Day 3
Time Frame: Day 3
Refers to the subjective sensation of increased abdominal pressure without an increase in abdominal size, the number of defecations were quantified at day 3 and compared between both groups.
Day 3
Number of Participants With Distension on Day 3
Time Frame: Day 3
Is a visible increase in abdominal girth.1. Present, 2. Absent.
Day 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Saturation Without Supplementary Oxygen
Time Frame: day 40
The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge.
day 40
Need for Home Oxygen Flow
Time Frame: Day 40
The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.
Day 40
Time of Home Oxigen Use
Time Frame: day 40
It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge
day 40
Post Covid Syndrome
Time Frame: Day 40.
Persistence of clinical signs and symptoms that arise after developing COVID-19, and are not explained by an alternative diagnosis. 1. Present. 2. Absent.
Day 40.
Weight Decrease
Time Frame: Day 40
Is defined as at least a 5% reduction in weight from the baseline level.Total number of patients with weight loss at the end of follow-up at day 40
Day 40
Gastrointestinal Symptoms
Time Frame: Day 40
Total number of patients with gastrointestinal symptoms at the end of follow-up at day 40.Those symptoms perceived abdominal region (pain, burn, pressure, nausea, vomiting)
Day 40
Number of Deceased Patients Stratified by Fibrinogen Level.
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients.
Baseline
Number of Deceased Patients Stratified by Procalcitonin Level.
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline
Number of Deceased Patients Stratified by Ureic Nitrogen Level
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline
Number of Deceased Participants Stratified by RCP Level
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline
Number of Deceased Participants Stratified by Neutrophils Level
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline
Number of Deceased Participants Stratified by Leukocytes Level
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline
Number of Deceased Participants Stratified by Urea Level
Time Frame: Baseline
Association between the presentation of certain laboratory parameters taken in the baseline period, with te overall mortality of discharge patients in comparison with deceased patients
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anahuac University

Investigators

  • Principal Investigator: Fernado Leal Martínez, Ph.D, Anahuac University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2020

Primary Completion (Actual)

April 10, 2021

Study Completion (Actual)

April 10, 2021

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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