COVID19, Diabetes Mellitus, Hypertension, Inflammation, Mortality, Obesity, Overweight, Oxygen Saturation
Conditions
Keywords
COVID19, Nutritional support, SARS-COV-2, Pneumonia, Supplementation, Probiotics
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.
Interventions
DIETARY_SUPPLEMENTNutritional 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.
OTHERConventional 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.
Sponsors
Anahuac University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
blinding was planned for patients and evaluators (treating physicians , care provider and laboratory personnel)
Intervention model description
exploratory study, it is a controlled, blinded, randomized clinical trial design.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 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 | 40 days. | Total number of patients who died before day 40 of follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression to Mechanical Ventilation Assistance | 10 days. | total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay. |
| Participants With Normal Bristol Scale at Day 3 | 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. |
| Survival in Intubated Patients at Day 40 | 40 days | Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up |
| Mortality in Intubated Patients at Day 40 | 40 days | Patients who were intubated during their hospital stay and died before completing follow-up on day 40. |
| Hidric Balance on Day 3 | 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. |
| Oxigen Saturation >90% on Day 3 | day 3. | the total number of patients with oxygen saturation \>90% on day 3 of their hospital stay. |
| PHQ-9 Test | 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. |
| Oxigen Flow (Intragroup) | baseline and day 3 | Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group. |
| qSOFA at Day 3 | 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. |
| Number of Defectations on Day 3 | 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. |
| Number of Participants With Distension on Day 3 | Day 3 | Is a visible increase in abdominal girth.1. Present, 2. Absent. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Saturation Without Supplementary Oxygen | day 40 | The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge. |
| Time of Home Oxigen Use | day 40 | It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge |
| Need for Home Oxygen Flow | Day 40 | The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No. |
| Post Covid Syndrome | 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. |
| Weight Decrease | 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 |
| Gastrointestinal Symptoms | 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) |
| Number of Deceased Patients Stratified by Fibrinogen Level. | Baseline | Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients. |
| Number of Deceased Patients Stratified by Procalcitonin Level. | 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 |
| Number of Deceased Patients Stratified by Ureic Nitrogen Level | 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 |
| Number of Deceased Participants Stratified by RCP Level | 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 |
| Number of Deceased Participants Stratified by Neutrophils Level | 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 |
| Number of Deceased Participants Stratified by Leukocytes Level | 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 |
| Number of Deceased Participants Stratified by Urea Level | 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 |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center. | 40 |
| Intervention Group Patients who received medical treatment indicated by the hospital and a diet established by the hospital nutrition department of the ISSEMyM Toluca Arturo Montiel Rojas Medical Center.
Also it received the Nutritional support system (NSS), which consists of:
1. 10 mg of cyanocobalamin, 100 mg of thiamin and 100 mg of pyridoxine administered intramuscularly every 24 hours for the first 5 days.
2. Probiotics Saccharomyces Boulardii (SB) 50 million CFU daily for 6 days orally.
3. One packet of NSS orally after morning meals and another after evening meals, mixed with 400 ml of water each, during the whole intervention for a maximum of 21 days. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 1 |
Baseline characteristics
| Characteristic | Total | Intervention Group | Control Group |
|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 10.9 | 51.5 years STANDARD_DEVIATION 11.4 | 53.9 years STANDARD_DEVIATION 10.3 |
| Albumin | 3.55 g/dL STANDARD_DEVIATION 0.42 | 3.57 g/dL STANDARD_DEVIATION 0.41 | 3.53 g/dL STANDARD_DEVIATION 0.44 |
| ALT | 49.06 U/L STANDARD_DEVIATION 42.21 | 50.44 U/L STANDARD_DEVIATION 50.88 | 47.69 U/L STANDARD_DEVIATION 31.9 |
| Antiacids | 12 Participants | 6 Participants | 6 Participants |
| Antibiotics medication | 5 Participants | 4 Participants | 1 Participants |
| Antidiabetics medication | 20 Participants | 11 Participants | 9 Participants |
| Antihypertensive medication | 22 Participants | 9 Participants | 13 Participants |
| Antilipids medication | 6 Participants | 3 Participants | 3 Participants |
| AST | 47.2 U/L STANDARD_DEVIATION 40.3 | 46.4 U/L STANDARD_DEVIATION 49.65 | 48.06 U/L STANDARD_DEVIATION 28.81 |
| basal energy intake | 1393.5 kilocalories STANDARD_DEVIATION 43.3 | 1376 kilocalories STANDARD_DEVIATION 36.3 | 1411 kilocalories STANDARD_DEVIATION 46.2 |
| Blood urea nitrogen (BUN) | 15.65 mg/dl STANDARD_DEVIATION 6.29 | 15.43 mg/dl STANDARD_DEVIATION 5.02 | 15.87 mg/dl STANDARD_DEVIATION 7.39 |
| Body Mass Index (BMI) | 29.66 kg/m^2 STANDARD_DEVIATION 3.97 | 29.98 kg/m^2 STANDARD_DEVIATION 4.07 | 29.35 kg/m^2 STANDARD_DEVIATION 3.89 |
| Body Temperature (ºC) | 36.25 degrees Celsius (ºC) STANDARD_DEVIATION 0.67 | 36.25 degrees Celsius (ºC) STANDARD_DEVIATION 0.62 | 36.27 degrees Celsius (ºC) STANDARD_DEVIATION 0.73 |
| Breathing Frequency | 21.32 breaths per minute STANDARD_DEVIATION 2.99 | 21.48 breaths per minute STANDARD_DEVIATION 3.01 | 21.18 breaths per minute STANDARD_DEVIATION 3.01 |
| Bristol scale normal (T3-4) | 14 Participants | 5 Participants | 9 Participants |
| Cardiovascular Disease and/or Hypertension | 27 Participants | 10 Participants | 17 Participants |
| CRP | 146.3 mg/l STANDARD_DEVIATION 100.9 | 135.3 mg/l STANDARD_DEVIATION 94.92 | 157.3 mg/l STANDARD_DEVIATION 106.7 |
| D dimer | 368 μg/ml STANDARD_DEVIATION 686.4 | 444.9 μg/ml STANDARD_DEVIATION 954.9 | 291.2 μg/ml STANDARD_DEVIATION 179.9 |
| Diabetes Mellitus 2 | 24 Participants | 11 Participants | 13 Participants |
| Dysgeusia | 38 Participants | 20 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants | 40 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ferritin | 1167 ng/ml STANDARD_DEVIATION 1022 | 1270 ng/ml STANDARD_DEVIATION 1142 | 1070 ng/ml STANDARD_DEVIATION 899.3 |
| Fibrinogen | 600 mg/dl STANDARD_DEVIATION 165.3 | 607.4 mg/dl STANDARD_DEVIATION 162.9 | 592.2 mg/dl STANDARD_DEVIATION 170.4 |
| Glomerular filtration rate (GFR) | 91.84 mL/min/1.73 m^2 STANDARD_DEVIATION 18.82 | 93.59 mL/min/1.73 m^2 STANDARD_DEVIATION 17.4 | 90.15 mL/min/1.73 m^2 STANDARD_DEVIATION 20.2 |
| Glycemia | 135.12 mg/dL STANDARD_DEVIATION 58.73 | 134.8 mg/dL STANDARD_DEVIATION 58.83 | 135.4 mg/dL STANDARD_DEVIATION 59.39 |
| Hemoglobin | 15.53 g/dL STANDARD_DEVIATION 2.14 | 15.54 g/dL STANDARD_DEVIATION 2.08 | 15.53 g/dL STANDARD_DEVIATION 2.22 |
| Hydric Balance | -254.1 milliliters STANDARD_DEVIATION 1056 | -301.5 milliliters STANDARD_DEVIATION 1167 | -203.4 milliliters STANDARD_DEVIATION 966 |
| Hyperlipidemia | 18 Participants | 7 Participants | 11 Participants |
| Hyposmia | 27 Participants | 15 Participants | 12 Participants |
| Leukocytes | 8.72 10^3 leukocytes / μL STANDARD_DEVIATION 4.23 | 8.46 10^3 leukocytes / μL STANDARD_DEVIATION 4.36 | 8.97 10^3 leukocytes / μL STANDARD_DEVIATION 4.15 |
| Liters of Supplemental Oxygen | 5.97 L/min STANDARD_DEVIATION 3.54 | 6 L/min STANDARD_DEVIATION 3.29 | 5.9 L/min STANDARD_DEVIATION 3.82 |
| Mean Corpuscular Hemoglobin Concentration | 33.42 g/dL STANDARD_DEVIATION 1.28 | 33.46 g/dL STANDARD_DEVIATION 1.17 | 33.39 g/dL STANDARD_DEVIATION 1.4 |
| MNA (Mini Nutritional Assessment) Score | 11.25 units on a scale STANDARD_DEVIATION 1.97 | 11.38 units on a scale STANDARD_DEVIATION 1.65 | 11.13 units on a scale STANDARD_DEVIATION 2.26 |
| Nausea and Vomiting | 13 Participants | 7 Participants | 6 Participants |
| Neutrophils | 82.14 percentage STANDARD_DEVIATION 9.12 | 80.78 percentage STANDARD_DEVIATION 9.29 | 83.5 percentage STANDARD_DEVIATION 8.87 |
| NSAIDs medication | 20 Participants | 12 Participants | 8 Participants |
| Number of defecations | 0.53 Number of defecations per day STANDARD_DEVIATION 0.66 | 0.52 Number of defecations per day STANDARD_DEVIATION 0.73 | 0.54 Number of defecations per day STANDARD_DEVIATION 0.6 |
| Number of Participants with Abdominal Distension | 56 Participants | 28 Participants | 28 Participants |
| Number of Participants with Anorexia | 41 Participants | 21 Participants | 20 Participants |
| Number of Participants with Diarrhea | 30 Participants | 12 Participants | 18 Participants |
| Number of Participants with Dyspnea | 50 Participants | 26 Participants | 24 Participants |
| Number of Participants with Gastrointestinal Disease | 27 Participants | 13 Participants | 14 Participants |
| Number of Participants with Headache | 55 Participants | 29 Participants | 26 Participants |
| Number of Participants with Myalgia | 62 Participants | 30 Participants | 32 Participants |
| Obesity Type I-II | 27 Participants | 13 Participants | 14 Participants |
| Overweight | 74 Participants | 36 Participants | 38 Participants |
| Oxygen Saturation | 93.36 oxygen saturation percentage STANDARD_DEVIATION 3.74 | 94 oxygen saturation percentage STANDARD_DEVIATION 3.18 | 92.73 oxygen saturation percentage STANDARD_DEVIATION 4.17 |
| Platelets | 235.3 10^3 platelets / μL STANDARD_DEVIATION 106.1 | 248.4 10^3 platelets / μL STANDARD_DEVIATION 139.9 | 222.2 10^3 platelets / μL STANDARD_DEVIATION 53.93 |
| Procalcitonin | 0.27 μg/L STANDARD_DEVIATION 0.45 | 0.18 μg/L STANDARD_DEVIATION 0.188 | 0.364 μg/L STANDARD_DEVIATION 0.6 |
| qSOFA Score | 0.53 units on a scale STANDARD_DEVIATION 0.61 | 0.65 units on a scale STANDARD_DEVIATION 0.62 | 0.425 units on a scale STANDARD_DEVIATION 0.59 |
| Region of Enrollment Mexico | 80 participants | 40 participants | 40 participants |
| Resting Heart Rate | 73.07 beats per minute STANDARD_DEVIATION 13.07 | 75.5 beats per minute STANDARD_DEVIATION 9.88 | 70.7 beats per minute STANDARD_DEVIATION 15.4 |
| Serum Creatinine | 0.87 mg/dl STANDARD_DEVIATION 0.27 | 0.86 mg/dl STANDARD_DEVIATION 0.22 | 0.88 mg/dl STANDARD_DEVIATION 0.31 |
| Sex: Female, Male Female | 28 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Male | 52 Participants | 25 Participants | 27 Participants |
| Total cholesterol | 138.98 mg/dL STANDARD_DEVIATION 34.65 | 135 mg/dL STANDARD_DEVIATION 23.53 | 142.8 mg/dL STANDARD_DEVIATION 42.82 |
| Total of symptoms | 6.92 number of symptoms STANDARD_DEVIATION 2.16 | 6.8 number of symptoms STANDARD_DEVIATION 2.23 | 7.05 number of symptoms STANDARD_DEVIATION 2.11 |
| Total Risk Factors | 2.75 number of risk factors STANDARD_DEVIATION 1.39 | 2.57 number of risk factors STANDARD_DEVIATION 1.35 | 2.92 number of risk factors STANDARD_DEVIATION 1.42 |
| Triglycerides | 140.2 mg/dL STANDARD_DEVIATION 49.6 | 132.8 mg/dL STANDARD_DEVIATION 37.39 | 147.5 mg/dL STANDARD_DEVIATION 58.92 |
| Urea | 33.42 mg/dl STANDARD_DEVIATION 13.47 | 32.95 mg/dl STANDARD_DEVIATION 10.78 | 33.95 mg/dl STANDARD_DEVIATION 15.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 40 | 1 / 40 |
| other Total, other adverse events | 0 / 40 | 5 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Overall Mortality at Day 40
Total number of patients who died before day 40 of follow-up.
Time frame: 40 days.
Population: total number of patients who were enrolled in the study and died prior to day 40 of follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Overall Mortality at Day 40 | 7 Participants |
| Intervention Group | Overall Mortality at Day 40 | 1 Participants |
Primary
Overall Survival
Overall survival, the total number of patients included in the study and completed a 40-day follow-up.
Time frame: 40 days.
Population: the total number of patients who were enrolled and included in the study and who survived or not at the end of follow-up at day 40.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Overall Survival | 33 Participants |
| Intervention Group | Overall Survival | 39 Participants |
Comparison: The total number of patients who did or did not survive to day 40 of follow-up.p-value: 0.027Log Rank
Secondary
Hidric Balance on Day 3
The ratio between the water assimilated into the body and that lost from the body, in milliliters.
Time frame: It is evaluated on day 3 of hospital stay (duration approximately 10 minutes).
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Hidric Balance on Day 3 | 123.4 milliliters | Standard Deviation 453.8 |
| Intervention Group | Hidric Balance on Day 3 | 456.6 milliliters | Standard Deviation 485.5 |
Comparison: Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.p-value: 0.043t-test, 1 sided
Secondary
Mortality in Intubated Patients at Day 40
Patients who were intubated during their hospital stay and died before completing follow-up on day 40.
Time frame: 40 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Mortality in Intubated Patients at Day 40 | 5 Participants |
| Intervention Group | Mortality in Intubated Patients at Day 40 | 1 Participants |
Secondary
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.
Time frame: Day 3
Population: Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Number of Defectations on Day 3 | 0.81 defecations | Standard Deviation 0.9 |
| Intervention Group | Number of Defectations on Day 3 | 1.41 defecations | Standard Deviation 1.13 |
Comparison: Intergroup analysis between both groups to evaluate the number of defecations measured at day 3.p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Distension on Day 3
Is a visible increase in abdominal girth.1. Present, 2. Absent.
Time frame: Day 3
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Number of Participants With Distension on Day 3 | 51.6 percent of participants |
| Intervention Group | Number of Participants With Distension on Day 3 | 19.4 percent of participants |
Comparison: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay. Deceased patients were excluded.p-value: 0.008Fisher Exact
Secondary
Oxigen Flow (Intragroup)
Difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
Time frame: baseline and day 3
Population: Intragroup and Intergroup analysis between the control group and the intervention group for the difference in oxygen delivery between the baseline period and day 3 of hospital stay in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Oxigen Flow (Intragroup) | Baseline | 5.9 Liters (L) | Standard Deviation 3.8 |
| Control Group | Oxigen Flow (Intragroup) | Day 3 | 6 Liters (L) | Standard Deviation 4.4 |
| Intervention Group | Oxigen Flow (Intragroup) | Day 3 | 4.5 Liters (L) | Standard Deviation 3.5 |
| Intervention Group | Oxigen Flow (Intragroup) | Baseline | 6 Liters (L) | Standard Deviation 3.2 |
Comparison: Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.p-value: 0.919t-test, 2 sided
Comparison: Intragroup analysis of the control group in oxygen delivery, the difference between the baseline period and day 3 of hospital stay.p-value: 0.014t-test, 2 sided
Secondary
Oxigen Saturation >90% on Day 3
the total number of patients with oxygen saturation \>90% on day 3 of their hospital stay.
Time frame: day 3.
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Oxigen Saturation >90% on Day 3 | 34 Participants |
| Intervention Group | Oxigen Saturation >90% on Day 3 | 37 Participants |
Comparison: Intergroup analysis between the control group and the intervention group for different parameters, measured at day 3 of hospital stay . Deceased patients were excluded.p-value: 0.241Fisher Exact
Secondary
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.
Time frame: day 3
Population: Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay . Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Participants With Normal Bristol Scale at Day 3 | 8 Participants |
| Intervention Group | Participants With Normal Bristol Scale at Day 3 | 13 Participants |
Comparison: Intergroup analysis between the control group and the intervention group, measured at day 3 of hospital stay. It was categorized as follows: 1. normal bristol scale at day 3; 2. abnormal bristol scale at day 3.p-value: 0.35Fisher Exact
Secondary
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.
Time frame: baseline and hospital discharge
Population: Intragroup analysis between the control group and the intervention group for different parameters, measured at baseline and at hospital discharge.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | PHQ-9 Test | Baseline | 3.66 score on a scale | Standard Deviation 2.5 |
| Control Group | PHQ-9 Test | Hospital discharge | 1.50 score on a scale | Standard Deviation 2.8 |
| Intervention Group | PHQ-9 Test | Hospital discharge | 1.9 score on a scale | Standard Deviation 1.4 |
| Intervention Group | PHQ-9 Test | Baseline | 5.3 score on a scale | Standard Deviation 3.4 |
Comparison: Intragroup analysis at the control group, the measurement was performed at baseline and at hospital discharge.p-value: 0.187t-test, 2 sided
Comparison: Intragroup analysis at the intervention group, the measurement was performed at baseline and at hospital discharge.p-value: 0.003t-test, 2 sided
Secondary
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.
Time frame: 10 days.
Population: Proportion of patients from control group and intervention group were analyzed with the Kaplan-Meier method comparing both groups to MVA progression
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Progression to Mechanical Ventilation Assistance | 7 Participants |
| Intervention Group | Progression to Mechanical Ventilation Assistance | 3 Participants |
Comparison: total number of patients included in the study who progressed to mechanical ventilation during the first 10 days of hospital stay.p-value: 0.186Log Rank
Secondary
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.
Time frame: Baseline and Day 3
Population: Intragroup analysis of both groups, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | qSOFA at Day 3 | Baseline | 0.42 score on a scale | Standard Deviation 0.59 |
| Control Group | qSOFA at Day 3 | Day 3 | 0.51 score on a scale | Standard Deviation 0.57 |
| Intervention Group | qSOFA at Day 3 | Baseline | 0.65 score on a scale | Standard Deviation 0.62 |
| Intervention Group | qSOFA at Day 3 | Day 3 | 0.43 score on a scale | Standard Deviation 0.49 |
Comparison: Intragroup analysis of the control group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.p-value: 0.608Wilcoxon (Mann-Whitney)
Comparison: Intragroup analysis of the intervention group, the difference in the qSOFA measurement at baseline and at day 3 will be analyzed.p-value: 0.04t-test, 2 sided
Secondary
Survival in Intubated Patients at Day 40
Total number of patients who were intubated, extubated, discharged and completes the 40 day follow-up
Time frame: 40 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Survival in Intubated Patients at Day 40 | 2 Participants |
| Intervention Group | Survival in Intubated Patients at Day 40 | 2 Participants |
Comparison: the total number of patients who were intubated and survived at the end of day 40 follow-up.p-value: 0.495Log Rank
Other Pre-specified
Gastrointestinal Symptoms
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)
Time frame: Day 40
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Gastrointestinal Symptoms | 4 Participants |
| Intervention Group | Gastrointestinal Symptoms | 3 Participants |
Comparison: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.p-value: 0.266Fisher Exact
Other Pre-specified
Need for Home Oxygen Flow
The need to continue with supplemental oxygen at hospital discharge. Categories: 1. Yes, 2. No.
Time frame: Day 40
Population: Intragroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days of hospital stay. Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Need for Home Oxygen Flow | 23 Participants |
| Intervention Group | Need for Home Oxygen Flow | 26 Participants |
p-value: 0.078Fisher Exact
Other Pre-specified
Number of Deceased Participants Stratified by Leukocytes Level
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Participants Stratified by Leukocytes Level | 3 Participants |
| Intervention Group | Number of Deceased Participants Stratified by Leukocytes Level | 5 Participants |
p-value: 0.04Fisher Exact
Other Pre-specified
Number of Deceased Participants Stratified by Neutrophils Level
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Participants Stratified by Neutrophils Level | 0 Participants |
| Intervention Group | Number of Deceased Participants Stratified by Neutrophils Level | 8 Participants |
p-value: 0.031Fisher Exact
Other Pre-specified
Number of Deceased Participants Stratified by RCP Level
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Participants Stratified by RCP Level | 1 Participants |
| Intervention Group | Number of Deceased Participants Stratified by RCP Level | 7 Participants |
p-value: 0.011Fisher Exact
Other Pre-specified
Number of Deceased Participants Stratified by Urea Level
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Participants Stratified by Urea Level | 4 Participants |
| Intervention Group | Number of Deceased Participants Stratified by Urea Level | 4 Participants |
p-value: 0.047Fisher Exact
Other Pre-specified
Number of Deceased Patients Stratified by Fibrinogen Level.
Association between the presentation of certain laboratory parameters taken at baseline with the overall mortality of discharged patients compared to deceased patients.
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Patients Stratified by Fibrinogen Level. | 2 Participants |
| Intervention Group | Number of Deceased Patients Stratified by Fibrinogen Level. | 6 Participants |
p-value: 0.002Fisher Exact
Other Pre-specified
Number of Deceased Patients Stratified by Procalcitonin Level.
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Patients Stratified by Procalcitonin Level. | 4 Participants |
| Intervention Group | Number of Deceased Patients Stratified by Procalcitonin Level. | 4 Participants |
p-value: 0.003Fisher Exact
Other Pre-specified
Number of Deceased Patients Stratified by Ureic Nitrogen Level
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
Time frame: Baseline
Population: Association between the presentation of certain laboratory parameters taken at baseline compared to overall mortality.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Deceased Patients Stratified by Ureic Nitrogen Level | 4 Participants |
| Intervention Group | Number of Deceased Patients Stratified by Ureic Nitrogen Level | 4 Participants |
p-value: 0.004Fisher Exact
Other Pre-specified
Post Covid Syndrome
Persistence of clinical signs and symptoms that arise after developing COVID-19, and are not explained by an alternative diagnosis. 1. Present. 2. Absent.
Time frame: Day 40.
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Post Covid Syndrome | 9 Participants |
| Intervention Group | Post Covid Syndrome | 8 Participants |
Comparison: Intergroup analysis between the control group and the intervention group to analyze the presentation of post covid syndrome at the end of follow-up at day 40.p-value: 0.195Fisher Exact
Other Pre-specified
Saturation Without Supplementary Oxygen
The oxygen saturation without supplementary oxygen is taken at the control appointment 40 days after hospital discharge.
Time frame: day 40
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Saturation Without Supplementary Oxygen | 90.39 percentage | Standard Deviation 3.4 |
| Intervention Group | Saturation Without Supplementary Oxygen | 92.08 percentage | Standard Deviation 2.5 |
Other Pre-specified
Time of Home Oxigen Use
It is recorded for how many days the treating doctor asked the patients to continue to administer supplemental oxygen after hospital discharge
Time frame: day 40
Population: Intragroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Time of Home Oxigen Use | 57.6 days | Standard Deviation 24.6 |
| Intervention Group | Time of Home Oxigen Use | 43.8 days | Standard Deviation 16.2 |
Comparison: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excludedp-value: 0.098t-test, 1 sided
Other Pre-specified
Weight Decrease
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
Time frame: Day 40
Population: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Weight Decrease | 8 Participants |
| Intervention Group | Weight Decrease | 8 Participants |
Comparison: Intergroup analysis between the control group and the intervention group for different parameters, measured at a complete follow-up of 40 days. Deceased patients were excluded.p-value: 0.135Fisher Exact