N/A
N=80
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
COVID19 · Diabetes Mellitus · Hypertension · Obesity · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT04507867 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Overall Survival — 33; 39 Participants — p=0.027
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutritional support system (NSS) (Dietary_supplement); Conventional nutritional support designed by hospital nutritionists (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Anahuac University
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
33; 39 | 0.027 sig |
| PRIMARY Overall Mortality at Day 40 |
7; 1 | — |
| SECONDARY Survival in Intubated Patients at Day 40 |
2; 2 | 0.495 |
| SECONDARY Mortality in Intubated Patients at Day 40 |
5; 1 | — |
| SECONDARY Progression to Mechanical Ventilation Assistance |
7; 3 | 0.186 |
| SECONDARY Participants With Normal Bristol Scale at Day 3 |
8; 13 | 0.35 |
| SECONDARY Hidric Balance on Day 3 |
123.4; 456.6 | 0.043 sig |
| SECONDARY Oxigen Saturation >90% on Day 3 |
34; 37 | 0.241 |
| SECONDARY PHQ-9 Test |
3.66; 5.3; 1.50; 1.9 | 0.187 |
| SECONDARY Oxigen Flow (Intragroup) |
5.9; 6; 6; 4.5 | 0.919 |
| SECONDARY qSOFA at Day 3 |
0.42; 0.65; 0.51; 0.43 | 0.608 |
| SECONDARY Number of Defectations on Day 3 |
0.81; 1.41 | 0.014 sig |
| SECONDARY Number of Participants With Distension on Day 3 |
51.6; 19.4 | 0.008 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04507867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.