COVID19NCT04507867
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
A study testing Nutritional support system (NSS) and Conventional nutritional support designed by hospital nutritionists in people with COVID19 and Diabetes Mellitus, run by Anahuac University at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- COVID19, Diabetes Mellitus, Hypertension
- What is being tested?
- Nutritional support system (NSS) and Conventional nutritional support designed by hospital nutritionists
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMexico
- Study dates
- 7 Sep 2020to 10 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
ISSEMYM "Arturo Montiel Rojas" Medical Center
Toluca, State of Mexico, 52140
About this study
Official title: 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 ?.
Read more
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.
Read the 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:
- Application and consumption of NSS supplementation as appropriate.
- Morning and evening vital signs.
- 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).
- Anthropometric measurements using a scale every 2 days (only if the patient is stable and can maintain balance).
- Food diaries of each patient.
- 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.
- Conditions
- COVID19, Diabetes Mellitus, Hypertension, Obesity, Overweight, Oxygen Saturation
- Being tested
- Nutritional support system (NSS), Conventional nutritional support designed by hospital nutritionists
- Keywords
- COVID19, Nutritional support, SARS-COV-2, Pneumonia, Supplementation, Probiotics
- Medical subject headings
- COVID-19, Diabetes Mellitus, Hypertension, Obesity, Overweight, Inflammation, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional support system (NSS)Dietary supplement
- 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.
- Probiotics Saccharomyces boulardii CNCM I-745 "Floratil". One morning and one evening 250 mg capsule during the first 6 days
- 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.
Conventional nutritional support designed by hospital nutritionistsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | Patients who received the standard diet Receives: Other: Conventional nutritional support designed by hospital nutritionists |
| Intervention group | Experimental | Patients who received the nutritional support system (NSS) and the standard diet Receives: Dietary Supplement: Nutritional support system (NSS); Other: Conventional nutritional support designed by hospital nutritionists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
Measured: 40 days.
Overall Mortality at Day 40
Total number of patients who died before day 40 of follow-up.
Measured: 40 days.
Secondary outcomes (11)
Survival in Intubated Patients at Day 40
Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up
Measured: 40 days
Mortality in Intubated Patients at Day 40
Patients who were intubated during their hospital stay and died before completing follow-up on day 40.
Measured: 40 days
Progression to Mechanical Ventilation Assistance
total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.
Measured: 10 days.
Participants With Normal Bristol Scale at 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".
Measured: day 3
Hidric Balance on Day 3
The ratio between the water assimilated into the body and that lost from the body, in milliliters.
Measured: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Oxigen Saturation >90% on Day 3
the total number of patients with oxygen saturation >90% on day 3 of their hospital stay.
Measured: day 3.
PHQ-9 Test
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.
Measured: baseline and hospital discharge
Oxigen Flow (Intragroup)
Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
Measured: baseline and day 3
qSOFA at 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.
Measured: Baseline and Day 3
Number of Defectations on 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.
Measured: Day 3
Number of Participants With Distension on Day 3
Is a visible increase in abdominal girth.1. Present, 2. Absent.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start7 Sep 2020
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- exploratory study, it is a controlled, blinded, randomized clinical trial design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anahuac University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Leal-Martinez, Anahuac University
- Investigators
- Fernado Leal Martínez, Ph.D, Principal investigator, Anahuac University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507867
- Sponsor's protocol ID
- 202036
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2020
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hummel T, Landis BN, Huttenbrink KB. Smell and taste disorders. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2011;10:Doc04. doi: 10.3205/cto000077. Epub 2012 Apr 26.
PubMed 22558054Mortazavi H, Shafiei S, Sadr S, Safiaghdam H. Drug-related Dysgeusia: A Systematic Review. Oral Health Prev Dent. 2018;16(6):499-507. doi: 10.3290/j.ohpd.a41655.
PubMed 30574604Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.
PubMed 26690980Seo AY, Kim N, Oh DH. Abdominal bloating: pathophysiology and treatment. J Neurogastroenterol Motil. 2013 Oct;19(4):433-53. doi: 10.5056/jnm.2013.19.4.433. Epub 2013 Oct 7.
PubMed 24199004Silva DAS, de Lima TR, Tremblay MS. Association between Resting Heart Rate and Health-Related Physical Fitness in Brazilian Adolescents. Biomed Res Int. 2018 Jun 28;2018:3812197. doi: 10.1155/2018/3812197. eCollection 2018.
PubMed 30050928Moskowitz A, Patel PV, Grossestreuer AV, Chase M, Shapiro NI, Berg K, Cocchi MN, Holmberg MJ, Donnino MW; Center for Resuscitation Science. Quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome Criteria as Predictors of Critical Care Intervention Among Patients With Suspected Infection. Crit Care Med. 2017 Nov;45(11):1813-1819. doi: 10.1097/CCM.0000000000002622.
PubMed 28759474Holvoet E, Vanden Wyngaert K, Van Craenenbroeck AH, Van Biesen W, Eloot S. The screening score of Mini Nutritional Assessment (MNA) is a useful routine screening tool for malnutrition risk in patients on maintenance dialysis. PLoS One. 2020 Mar 4;15(3):e0229722. doi: 10.1371/journal.pone.0229722. eCollection 2020.
PubMed 32130271Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7.
PubMed 27340299Babiker A, Al Dubayee M. Anti-diabetic medications: How to make a choice? Sudan J Paediatr. 2017;17(2):11-20. doi: 10.24911/SJP.2017.2.12.
PubMed 29545660Pahan K. Lipid-lowering drugs. Cell Mol Life Sci. 2006 May;63(10):1165-78. doi: 10.1007/s00018-005-5406-7.
PubMed 16568248Ghoshal K, Bhattacharyya M. Overview of platelet physiology: its hemostatic and nonhemostatic role in disease pathogenesis. ScientificWorldJournal. 2014 Mar 3;2014:781857. doi: 10.1155/2014/781857. eCollection 2014.
PubMed 24729754Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.
PubMed 28149530Hayiroglu MI, Cinar T, Tekkesin AI. Fibrinogen and D-dimer variances and anticoagulation recommendations in Covid-19: current literature review. Rev Assoc Med Bras (1992). 2020 Jun;66(6):842-848. doi: 10.1590/1806-9282.66.6.842. Epub 2020 Jul 20.
PubMed 32696883Knovich MA, Storey JA, Coffman LG, Torti SV, Torti FM. Ferritin for the clinician. Blood Rev. 2009 May;23(3):95-104. doi: 10.1016/j.blre.2008.08.001. Epub 2008 Oct 2.
PubMed 18835072Liu F, Li L, Xu M, Wu J, Luo D, Zhu Y, Li B, Song X, Zhou X. Prognostic value of interleukin-6, C-reactive protein, and procalcitonin in patients with COVID-19. J Clin Virol. 2020 Jun;127:104370. doi: 10.1016/j.jcv.2020.104370. Epub 2020 Apr 14.
PubMed 32344321
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutritional Support System to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
- ClinicalTrials.gov ID
- NCT04507867
- Acronym / sponsor ID
- 202036
- Conditions
- COVID19, Diabetes Mellitus, Hypertension, Obesity, Overweight, Oxygen Saturation
- Keywords
- COVID19, Nutritional support, SARS-COV-2, Pneumonia, Supplementation, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Anahuac UniversityUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 11 Aug 2020 (actual)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Application and consumption of NSS supplementation as appropriate.
- Morning and evening vital signs.
- 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).
- Anthropometric measurements using a scale every 2 days (only if the patient is stable and can maintain balance).
- Food diaries of each patient.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- exploratory study, it is a controlled, blinded, randomized clinical trial design.
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: Conventional nutritional support designed by hospital nutritionistsPatients who received the standard diet |
| Intervention group | Experimental | Dietary Supplement: Nutritional support system (NSS), Other: Conventional nutritional support designed by hospital nutritionistsPatients who received the nutritional support system (NSS) and the standard diet |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Intervention group |
| Conventional nutritional support designed by hospital nutritionistsDiet 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. | Other | Intervention group, control group |
Primary outcome
Overall Survival
Time frame: 40 days.
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
Overall Mortality at Day 40
Time frame: 40 days.
Total number of patients who died before day 40 of follow-up.
11 secondary outcomes
Survival in Intubated Patients at Day 40
Time frame: 40 days
Mortality in Intubated Patients at Day 40
Time frame: 40 days
Progression to Mechanical Ventilation Assistance
Time frame: 10 days.
Participants With Normal Bristol Scale at Day 3
Time frame: day 3
Hidric Balance on Day 3
Time frame: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Oxigen Saturation >90% on Day 3
Time frame: day 3.
PHQ-9 Test
Time frame: baseline and hospital discharge
Oxigen Flow (Intragroup)
Time frame: baseline and day 3
qSOFA at Day 3
Time frame: Baseline and Day 3
Number of Defectations on Day 3
Time frame: Day 3
Number of Participants With Distension on Day 3
Time frame: Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22558054Hummel T, Landis BN, Huttenbrink KB. Smell and taste disorders. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2011;10:Doc04. doi: 10.3205/cto000077. Epub 2012 Apr 26.
- Results publication: PubMed 30574604Mortazavi H, Shafiei S, Sadr S, Safiaghdam H. Drug-related Dysgeusia: A Systematic Review. Oral Health Prev Dent. 2018;16(6):499-507. doi: 10.3290/j.ohpd.a41655.
- Results publication: PubMed 26690980Chumpitazi BP, Self MM, Czyzewski DI, Cejka S, Swank PR, Shulman RJ. Bristol Stool Form Scale reliability and agreement decreases when determining Rome III stool form designations. Neurogastroenterol Motil. 2016 Mar;28(3):443-8. doi: 10.1111/nmo.12738. Epub 2015 Dec 21.
- Results publication: PubMed 24199004Seo AY, Kim N, Oh DH. Abdominal bloating: pathophysiology and treatment. J Neurogastroenterol Motil. 2013 Oct;19(4):433-53. doi: 10.5056/jnm.2013.19.4.433. Epub 2013 Oct 7.
- Results publication: PubMed 30050928Silva DAS, de Lima TR, Tremblay MS. Association between Resting Heart Rate and Health-Related Physical Fitness in Brazilian Adolescents. Biomed Res Int. 2018 Jun 28;2018:3812197. doi: 10.1155/2018/3812197. eCollection 2018.
- Results publication: PubMed 28759474Moskowitz A, Patel PV, Grossestreuer AV, Chase M, Shapiro NI, Berg K, Cocchi MN, Holmberg MJ, Donnino MW; Center for Resuscitation Science. Quick Sequential Organ Failure Assessment and Systemic Inflammatory Response Syndrome Criteria as Predictors of Critical Care Intervention Among Patients With Suspected Infection. Crit Care Med. 2017 Nov;45(11):1813-1819. doi: 10.1097/CCM.0000000000002622.
- Results publication: PubMed 32130271Holvoet E, Vanden Wyngaert K, Van Craenenbroeck AH, Van Biesen W, Eloot S. The screening score of Mini Nutritional Assessment (MNA) is a useful routine screening tool for malnutrition risk in patients on maintenance dialysis. PLoS One. 2020 Mar 4;15(3):e0229722. doi: 10.1371/journal.pone.0229722. eCollection 2020.
- Results publication: PubMed 27340299Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7.
- Results publication: PubMed 29545660Babiker A, Al Dubayee M. Anti-diabetic medications: How to make a choice? Sudan J Paediatr. 2017;17(2):11-20. doi: 10.24911/SJP.2017.2.12.
- Results publication: PubMed 16568248Pahan K. Lipid-lowering drugs. Cell Mol Life Sci. 2006 May;63(10):1165-78. doi: 10.1007/s00018-005-5406-7.
- Results publication: PubMed 24729754Ghoshal K, Bhattacharyya M. Overview of platelet physiology: its hemostatic and nonhemostatic role in disease pathogenesis. ScientificWorldJournal. 2014 Mar 3;2014:781857. doi: 10.1155/2014/781857. eCollection 2014.
- Results publication: PubMed 28149530Selders GS, Fetz AE, Radic MZ, Bowlin GL. An overview of the role of neutrophils in innate immunity, inflammation and host-biomaterial integration. Regen Biomater. 2017 Feb;4(1):55-68. doi: 10.1093/rb/rbw041.
- BMI Classification Percentile And Cut Off PointsLink provided by the sponsor.
- Diabetes Mellitus Type 2Link provided by the sponsor.
- Cardiovascular DiseaseLink provided by the sponsor.
- HyperlipidemiaLink provided by the sponsor.
- DyspneaLink provided by the sponsor.
- Chapter 84: Nausea and VomitingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernado Leal Martínez, Ph.D principal investigator
Anahuac University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional support system (NSS) and Conventional nutritional support designed by hospital nutritionists in people with COVID19 and Diabetes Mellitus, run by Anahuac University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 40 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04507867, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.