Clinical trial NCT04507867: Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
Official title: Effect of a Nutritional Support System to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID19
Diabetes Mellitus
Hypertension
Obesity
Overweight
Oxygen Saturation
Mortality
Inflammation
Keywords: COVID19
Nutritional support
SARS-COV-2
Pneumonia
Supplementation
Probiotics
Lead sponsor: Anahuac University
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: exploratory study, it is a controlled, blinded, randomized clinical trial design.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 40 days.
measure: Overall Mortality at Day 40
timeFrame: 40 days.
Secondary outcomes:
measure: Survival in Intubated Patients at Day 40
timeFrame: 40 days
measure: Mortality in Intubated Patients at Day 40
timeFrame: 40 days
measure: Progression to Mechanical Ventilation Assistance
timeFrame: 10 days.
measure: Participants With Normal Bristol Scale at Day 3
timeFrame: day 3
measure: Hidric Balance on Day 3
timeFrame: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
measure: Oxigen Saturation >90% on Day 3
timeFrame: day 3.
measure: PHQ-9 Test
timeFrame: baseline and hospital discharge
measure: Oxigen Flow (Intragroup)
timeFrame: baseline and day 3
measure: qSOFA at Day 3
timeFrame: Baseline and Day 3
measure: Number of Defectations on Day 3
timeFrame: Day 3
measure: Number of Participants With Distension on Day 3
timeFrame: Day 3
Other outcomes:
measure: Saturation Without Supplementary Oxygen
timeFrame: day 40
measure: Need for Home Oxygen Flow
timeFrame: Day 40
measure: Time of Home Oxigen Use
timeFrame: day 40
measure: Post Covid Syndrome
timeFrame: Day 40.
measure: Weight Decrease
timeFrame: Day 40
measure: Gastrointestinal Symptoms
timeFrame: Day 40
measure: Number of Deceased Patients Stratified by Fibrinogen Level.
timeFrame: Baseline
measure: Number of Deceased Patients Stratified by Procalcitonin Level.
timeFrame: Baseline
measure: Number of Deceased Patients Stratified by Ureic Nitrogen Level
timeFrame: Baseline
measure: Number of Deceased Participants Stratified by RCP Level
timeFrame: Baseline
measure: Number of Deceased Participants Stratified by Neutrophils Level
timeFrame: Baseline
measure: Number of Deceased Participants Stratified by Leukocytes Level
timeFrame: Baseline
measure: Number of Deceased Participants Stratified by Urea Level
timeFrame: Baseline
Locations:
city: Toluca de Lerdo
country: Mexico
facility: ISSEMYM "Arturo Montiel Rojas" Medical Center
state: Mexico State
Study officials:
affiliation: Anahuac University
name: Fernado Leal Martínez, Ph.D
role: PRINCIPAL_INVESTIGATOR
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