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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04507867
Recruitment Status : Completed
First Posted : August 11, 2020
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
Sponsor:
Information provided by (Responsible Party):
Fernando Leal-Martinez, Anahuac University

Brief 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.


Condition or disease Intervention/treatment Phase
COVID19 Diabetes Mellitus Hypertension Obesity Overweight Oxygen Saturation Mortality Inflammation Dietary Supplement: Nutritional support system (NSS) Other: Conventional nutritional support designed by hospital nutritionists Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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)
Masking Description: blinding was planned for patients and evaluators (treating physicians , care provider and laboratory personnel)
Primary Purpose: Treatment
Official Title: Effect of a Nutritional Support System to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
Actual Study Start Date : September 7, 2020
Actual Primary Completion Date : April 10, 2021
Actual Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


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
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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 40 days. ]
    Overall survival, the total number of patients included in the study and completed a 40-day follow-up.

  2. Overall Mortality at Day 40 [ Time Frame: 40 days. ]
    Total number of patients who died before day 40 of follow-up.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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".

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Number of Participants With Distension on Day 3 [ Time Frame: Day 3 ]
    Is a visible increase in abdominal girth.1. Present, 2. Absent.


Other Outcome Measures:
  1. 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.

  2. Need for Home Oxygen Flow [ Time Frame: Day 40 ]
    The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.

  3. 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

  4. 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.

  5. 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

  6. 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)

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507867


Locations
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Mexico
ISSEMYM "Arturo Montiel Rojas" Medical Center
Toluca de Lerdo, Mexico State, Mexico, 52140
Sponsors and Collaborators
Anahuac University
Investigators
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Principal Investigator: Fernado Leal Martínez, Ph.D Anahuac University
  Study Documents (Full-Text)

Documents provided by Fernando Leal-Martinez, Anahuac University:
Study Protocol  [PDF] July 28, 2020
Statistical Analysis Plan  [PDF] July 28, 2021
Informed Consent Form  [PDF] July 28, 2020

Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fernando Leal-Martinez, Doctor in Clinical Nutrition, Anahuac University
ClinicalTrials.gov Identifier: NCT04507867    
Other Study ID Numbers: 202036
First Posted: August 11, 2020    Key Record Dates
Results First Posted: October 15, 2021
Last Update Posted: October 15, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Leal-Martinez, Anahuac University:
COVID19
Nutritional support
SARS-COV-2
Pneumonia
Supplementation
Probiotics
Additional relevant MeSH terms:
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COVID-19
Inflammation
Overweight
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Body Weight