CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


ControlWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (16)


Name (Synonyms) Correlation
drug2552 Saliva sample collection Wiki 0.35
drug2316 Questionnaire forms Wiki 0.35
drug1938 Nutritional support system (NSS) Wiki 0.35
drug1202 Growth Mindset Wiki 0.35
drug271 Assessment of work-related stress Wiki 0.35
drug615 Cardiac and electrodermal recordings Wiki 0.35
drug295 Auricular neuromodulation Wiki 0.35
drug267 Assessment of behavioral response to emotional stimulation Wiki 0.35
drug1163 Gait Retraining Wiki 0.35
drug1516 KB109 + Self Supportive Care (SSC) Wiki 0.25
drug2575 Self Supportive Care (SSC) Alone Wiki 0.25
drug2235 Probiotic Wiki 0.20
drug2561 Sargramostim Wiki 0.20
drug3085 Vitamin C Wiki 0.20
drug1981 Online questionnaire Wiki 0.18
drug2311 Questionnaire Wiki 0.07

Correlated MeSH Terms (8)


Name (Synonyms) Correlation
D002055 Burnout, Professional NIH 0.47
D000077062 Burnout, Psychological NIH 0.21
D000073397 Occupational Stress NIH 0.20
D020370 Osteoarthritis, Knee NIH 0.20
D006973 Hypertension NIH 0.09
D003863 Depression, NIH 0.05
D018352 Coronavirus Infections NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.02

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0005086 Knee osteoarthritis HPO 0.20
HP:0000822 Hypertension HPO 0.09

There are 8 clinical trials

Clinical Trials


1 Lessening Organ Dysfunction With VITamin C (LOVIT)

LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.

NCT03680274 Sepsis Vitamin C Intensive Care Unit COVID-19 Pandemic Coronavirus Drug: Vitamin C Other: Control
MeSH:Coronavirus Infections

Primary Outcomes

Description: Defined as death or dependency on mechanical ventilation, renal replacement, or vasopressors

Measure: Number of deceased participants or with persistent organ dysfunction

Time: Both assessed at 28 days

Secondary Outcomes

Description: Persistent organ dysfunction-free days in intensive care unit

Measure: Number of participants with persistent organ dysfunction-free days in intensive care unit

Time: Up to day 28

Description: Mortality at 6 months

Measure: Number of participants deceased at 6 months

Time: 6 months

Description: Assessed by the questionnaire EuroQol-5D (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Measure: Score of health related quality of life in 6-month survivors

Time: 6 months

Description: Assessed by serum lactate concentration

Measure: Global tissue dysoxia

Time: Days 1, 3, 7

Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on 6 different sub-scores, one each for the respiratory (PaO2/FiO2 mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin (mg/dl) [μmol/L]), coagulation (platelets×103/µl), renal (kidneys creatinine (mg/dl) [μmol/L] (or urine output)) and neurological (Glasgow coma scale). The sub-score of eah system ranges from 0 (best) to +4 (worst).

Measure: Organ function (including renal function)

Time: Days 1, 2, 3, 4, 7, 10, 14, 28

Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP)

Measure: Rate of inflammation

Time: Days 1, 3, 7

Description: Assessed by procalcitonin (PCT)

Measure: Rate of infection

Time: Days 1, 3, 7

Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)

Measure: Rate of endothelial injury

Time: Days 1, 3, 7

Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria

Measure: Occurrence of stage 3 acute kidney injury

Time: Up to day 28

Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; Lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells

Measure: Acute hemolysis

Time: Up to day 28

Description: Core lab-validated glucose level of less than 3.8 mmol/L

Measure: Hypoglycemia

Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C volume of distribution

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C clearance

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

Description: Assessed by chromatography-tandem mass spectrometry

Measure: Vitamin C plasma concentration

Time: 6th dose of vitamin C (second dose on day 2) at time 0 (immediately prior to the dose) and then after administration at times 1 hour, 2 hours, 4 hours and 6 hours (Pharmacokynetic substudy)

2 Effect of Emotion Mindsets on Emotion Processing: A Multilevel Experimental Investigation

The guiding scientific premise for this research is that a growth emotion mindset will promote more adaptive emotion processing than a fixed emotion mindset. Because emotional sensitivity is particularly salient in adolescent girls, we will focus on this group. Using an experimental design, adolescent girls will be randomly assigned to either a mindset manipulation or a control group (brain education). Each group will complete a 25-minute computer-based lesson followed by a social stressor and a functional magnetic resonance imaging session. Two specific aims will be addressed: (1) to determine whether a growth mindset induction, relative to a control condition, predicts more adaptive emotion processing at the neural, behavioral, and psychological levels of processing; and (2) to determine whether neural processing of emotion accounts for the effect of a growth emotion mindset manipulation on behavioral and psychological processing of emotion. This study builds on a strong empirical database establishing the effect of mindsets on multiple domains of functioning but will be the first to examine the implications of a growth vs. fixed mindset about emotion for emotion processing in adolescent girls, thereby elucidating one specific youth attribute that can support or disrupt emotional development.

NCT03978871 Emotions Behavioral: Growth Mindset Behavioral: Control

Primary Outcomes

Description: Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=6 High=worse outcome

Measure: Mean Change from Pre to Post Mindset Manipulation on Emotion Mindset Scale (measures beliefs about whether emotions are fixed or malleable)

Time: Pre vs. Post Mindset Manipulation: baseline

Description: Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

Measure: Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Scale (measure beliefs about ability to control emotions)

Time: Pre vs. Post Mindset Manipulation: baseline

Description: Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

Measure: Mean Change from Pre to Post Mindset Manipulation on Emotional Self-efficacy Vignettes (measure beliefs about ability to control emotions in specific situations)

Time: Pre vs. Post Mindset Manipulation: baseline

Description: Will compare mean performance as reflected in reaction time and accuracy across the two conditions (mindset and control)

Measure: Mean Difference in Performance on Go/nogo Task

Time: Post Mindset Manipulation: baseline

Description: Will compare mean levels of self-reported emotion regulation strategies across the two conditions (mindset and control)

Measure: Mean Difference in Emotion Regulation Strategies

Time: Post Mindset Manipulation: baseline

Description: Will compare mean levels of amygdala activation during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

Measure: Mean Difference in Amygdala Activation

Time: Post Mindset Manipulation: baseline

Description: Will compare mean levels of frontal parietal network-amygdala connectivity during relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

Measure: Mean Difference in Frontal Parietal Network-Amygdala Connectivity

Time: Post Mindset Manipulation: baseline

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change on Self-Reported State Negative Affect

Time: Pre-Trier vs. Post-Trier: baseline

Secondary Outcomes

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Emotion Mindset Scores at 2 Months

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Emotion Mindset Scores at 4 Months

Time: At baseline and in approximately 4 months

Description: Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

Measure: Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 2 Months (measure beliefs about ability to control emotions)

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control) Minimum=1 Maximum=5 High=better outcome

Measure: Mean Change from Baseline in Emotional Self-efficacy Scale Scores at 4 Months (measure beliefs about ability to control emotions)

Time: At baseline and in approximately 4 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 2 months

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Emotional Self-efficacy Vignettes Scores at 4 months

Time: At baseline and in approximately 4 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 2 months

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Self-Reported Emotion Regulation Strategies Scores at 4 months

Time: At baseline and in approximately 4 months

Description: Will compare mean scores during relevant trials of the Social Evaluation Task across the two conditions (mindset and control)

Measure: Mean Difference on Self-Reported State Negative Affect

Time: Post Mindset Manipulation: baseline

Other Outcomes

Description: Will compare mean levels of cingulo-opercular network activation during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

Measure: Mean Difference in Cingulo-Opercular Network Activation

Time: Post Mindset Manipulation: baseline

Description: Will compare mean levels of cingulo-opercular network-amygdala connectivity during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

Measure: Mean Difference in Cingulo-Opercular Network-Amygdala Connectivity

Time: Post Mindset Manipulation: baseline

Description: Will conduct exploratory whole-brain analyses comparing activation patterns during resting state and relevant trials of the Social Evaluation Task and Go/no go Task across the two conditions (mindset and control)

Measure: Group Differences for Whole-Brain Analyses

Time: Post Mindset Manipulation: baseline

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Depressive Symptoms Scores at 2 months

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Depressive Symptoms Scores at 4 months

Time: At baseline and in approximately 4 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Anxiety Symptoms Scores at 2 months

Time: At baseline and in approximately 2 months

Description: Will compare mean change scores across the two conditions (mindset and control)

Measure: Mean Change from Baseline in Anxiety Symptoms Scores at 4 months

Time: At baseline and in approximately 4 months

3 Effectiveness of a Walking Intervention on Impact Loading and Pain

This study investigates the feasibility of a gait-retraining program for older adults with knee osteoarthritis. The study will enroll 40 participants, with 20 receiving a gait retraining intervention and 20 receiving a graded walking program without gait retraining.

NCT04148807 Osteoarthritis, Knee Knee Pain Chronic Behavioral: Gait Retraining Behavioral: Control
MeSH:Osteoarthritis, Knee
HPO:Knee osteoarthritis

Primary Outcomes

Description: # of participants screened per month

Measure: Recruitment rate

Time: through study completion, an average of 2 years

Description: # of participants enrolled per month

Measure: Enrollment rate

Time: through study completion, an average of 2 years

Description: % participants that complete all study visits

Measure: Retention

Time: through study completion, an average of 2 years

Secondary Outcomes

Description: Proportion of participants who withdraw or terminated by investigators and reasons why

Measure: Withdrawals/Terminated

Time: through study completion, an average of 2 years

Description: Proportion of participants with AE/UP

Measure: Adverse events (AE)/Unanticipated problems (UP)

Time: through study completion, an average of 2 years

Description: Slope of the most linear portion of the vertical ground reaction force curve, during early stance.

Measure: Vertical average loading rate

Time: Change from baseline to conclusion of intervention, an average of 1-month

Description: Maximum slope of the most vertical portion of the vertical ground reaction force curve between successive data points, during early stance.

Measure: Vertical instantaneous loading rate

Time: Change from baseline to conclusion of intervention, an average of 1-month

Description: WOMAC questionnaire, pain sub scale 0-20

Measure: Knee Pain with Activities

Time: Change from baseline to conclusion of intervention, an average of 1-month

Description: Visual analog scale, 0-100

Measure: Knee Pain Severity

Time: Change from baseline to conclusion of intervention, an average of 1-month

Description: Assessed using hand held algometer

Measure: Pressure pain threshold

Time: Change from baseline to conclusion of intervention, an average of 1-month

4 A Prospective, Randomized, Open-label, Interventional Study to Investigate the Efficacy of Sargramostim (Leukine®) in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 (Corona Virus Disease) Patients With Acute Hypoxic Respiratory Failure.

Phase IV study to evaluate the effectiveness of additional inhaled sargramostim (GM-CSF) versus standard of care on blood oxygenation in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure.

NCT04326920 COVID-19 Drug: Sargramostim Other: Control
MeSH:Respiratory Insufficiency

Primary Outcomes

Description: by mean change in PaO2/FiO2 (PaO2=Partial pressure of oxygen; FiO2= Fraction of inspired oxygen)

Measure: Improvement in oxygenation at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure

Time: at end of 5 day treatment period

Secondary Outcomes

Measure: Incidence of AE (Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Incidence of SAEs (Serious Adverse Event)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using 6-point ordinal scale

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using Clincal sign score

Time: at end of 5 day treatment period, 10 day period,10-20 weeks

Measure: Clinical Status using SOFA score (Sequential Organ Failure Assessment score),

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: Clinical Status using NEWS2 score (National Early Warning Score)

Time: at end of 5 day treatment period, 10 day period, 10-20 weeks

Description: demonstrated by bacterial or fungal culture

Measure: incidence of severe or life-threatening bacterial, invasive fungal or opportunistic infection

Time: during hospital admission (up to 28 days)

Measure: number of patients requiring initiation of mechanical ventilation

Time: during hospital admission (up to 28 days)

Measure: Number of deaths due to any cause at 4 weeks

Time: 4 weeks post inclusion

Measure: Number of deaths due to any cause at 20 weeks

Time: 20 weeks post inclusion

Description: defined by HS (Hemophagocytic Syndrome) score

Measure: number of patients developing features of secondary haemophagocytic lymphohistiocytosis

Time: at enrolment, end of 5 day treatment period, 10 day period, 10-20 weeks

Measure: long term Clinical status defined by 6-point ordinal scale

Time: 10-20 week

Measure: long term Clinical status defined by chest X-ray

Time: 10-20 weeks

Measure: long term Clinical status defined lung function

Time: 10-12 weeks

5 Randomized Double Blinded Monocentric Clinical Trial to Assess the Impact of Auricular Vagus Nerve Neuromodulation in COVID-19 Positive Inpatients Outcome.

The COVID-19 pandemic has already overwhelmed the sanitary capacity. Additional therapeutic arsenals, albeit untested in the given context but previously proven to be efficacious in a related clinical context, that could reduce the morbidity rate are urgently needed. A decrease of Heart Rate Variability (HRV) is a validated bad prognosis marker in sepsis and acute respiratory distress syndrome. In contrast, auricular vagus nerve stimulation was proven not only to increase HRV values in healthy Humans, but also to reduce sepsis and increase survival, both significantly, in experimental models. Moreover, the heavy viral infection within the brainstem of deceased patients suggests that the neuroinvasive potential of SARS-CoV2 is likely to be partially responsible for COVID-19 acute respiratory failure and may bear relevance in tailoring future treatment modalities. Interestingly, the vagus nerve (or tenth cranial nerve) connects bidirectionally the brainstem to various internal organs including the lung and to one external organ, namely, the outer ear. Hence, the impact of auricular vagus nerve stimulation through semi-permanent needles will be studied, mostly used so far for pain alleviation, on the outcome of COVID-19 inpatients within 15 days.

NCT04341415 Covid19 SARS-CoV Infection Procedure: Auricular neuromodulation Procedure: Control
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: Inpatients are considered as clinically improved if they have gained at least 2 points on the following clinical evaluation scale, or if they went back home Clinical evaluation scale :1. Outpatient back to normal activities / 2. Outpatient without normal activities / 3. Inpatient without oxygen therapy / 4. Inpatient with oxygen therapy/ 5. Inpatient requiring either nasal high-flow oxygen therapy or non-invasive respirator or both / 6. Inpatient, requiring either ExtraCorporeal Membrane Oxygenation (ECMO) or invasive artificial respirator, or both / 7. Deceased.

Measure: Comparison of the percentage of clinically improved inpatients between D0 and D14

Time: 14 day after intervention

6 Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19

The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study

NCT04366180 Covid-19 Dietary Supplement: Probiotic Dietary Supplement: Control

Primary Outcomes

Description: The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test

Measure: Incidence of SARS CoV-2 infection in healthcare workers

Time: 8 weeks

Secondary Outcomes

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required hospital admission because of Covid-19

Measure: Incidence of hospital admissions caused by SARS-CoV-2 infection

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required ICU admission because of Covid-19

Measure: Incidence of ICU admissions caused by SARS-CoV-2 infection

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop pneumonia because of Covid-19

Measure: Incidence of pneumonia caused by SARS-CoV-2 infection

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will require oxygen support because of Covid-19

Measure: Incidence of oxygen support requirement caused by SARS-CoV-2 infection

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop gastrointestinal symptoms because of Covid-19

Measure: Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with body's temperature > 37.5 ºC during the course of the disease

Measure: Days with body's temperature > 37.5 ºC

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease

Measure: Days with cough

Time: 8 weeks

Description: In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease

Measure: Days with fatigue

Time: 8 weeks

Description: Use of drugs (dosis and duration of the treatment) for Covid-19 treatment

Measure: Medical treatment

Time: 8 weeks

7 Lessening Organ Dysfunction With VITamin C - COVID

LOVIT-COVID is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in hospitalized COVID-19 patients.

NCT04401150 Vitamin C COVID-19 Hospitalized Patients Drug: Vitamin C Drug: Control

Primary Outcomes

Description: Number of deceased participants or with persistant organ dysfunction (dependency on mechanical ventilation, new renal replacement therapy, or vasopressors).

Measure: Death or persistent organ dysfunction

Time: Both assessed at 28 days

Secondary Outcomes

Description: Number of whole and part study days for which the patient is alive and not admitted to an intensive care unit

Measure: Number of intensive care unit-free days

Time: Assessed at 21 days

Description: Number of study days in ICU without persistant organ dysfunction

Measure: Persistent organ dysfunction-free days in ICU

Time: Assessed at 28 days

Description: Mortality at 6 months

Measure: Number of patients deceased at 6 months

Time: 6 months

Description: Assessed by the EQ-5D-5L EuroQol questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ-5D visual analog scale (EQ VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The patient is asked to indicate her/his health state by ticking the box next to the most appropriate statement in each of the 5 dimension. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ-VAS records the patient's self-rated health on a vertical visual analog scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Measure: Health related quality of life in 6-month survivors

Time: 6 months

Description: Assessed by the Sequential Organ Failure Assessment (SOFA) score. Used to track a person's status during the stay in an intensive care unit to determine the extent of a person's organ function or rate of failure. The score is based on six different sub-scores, one each for the respiratory (PaO2/fraction of inspired oxygen FiO2) mmHg), cardiovascular (mean arterial pressure OR administration of vasopressors required), hepatic (liver bilirubin mg/dl [µmol/L]), coagulation (platelets x 103/µl), renal (kidneys creatinine (mg/dl) [µmol/L] (or urine output)), and neurological (Glasgow coma scale). The sub-score of each system ranges from 0 (best) to +4 (worst).

Measure: Organ function

Time: Days 1, 2, 3, 4, 7, 10, 14, 28

Description: Assessed by serum lactate concentration

Measure: Global tissue dysoxia

Time: Days 1, 3, 7

Description: Assessed by interleukin-1 beta (IL-1ß), tumor necrosis factor-alpha (TNF-α), C-reactive protein (CRP).

Measure: Rate of inflammation

Time: Days 1, 3, 7

Description: Assessed by procalcitonin (PCT).

Measure: Rate of infection

Time: Days 1, 3, 7

Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2).

Measure: Rate of endothelial injury

Time: Days 1, 3, 7

Description: Assessed by Kidney Disease: Improving Global Outcomes (KDIGO) criteria

Measure: Occurrence of stage 3 acute kidney injury

Time: Up to day 28

Description: clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product plus 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin 2 times upper limit of normal at clinical site lab; lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: o hemoglobin <75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells.

Measure: Acute hemolysis

Time: Up to day 28

Description: Core lab-validated glucose level <3.8 mmol/L

Measure: Hypoglycemia

Time: During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose.

8 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 based on supplements such as omega 3, zinc, selenium, vitamin D, glutamine, prebiotics, and foods such as spirulina 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 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 8 of the Graphpad Prism software.

NCT04507867 Covid19 Diabetes Mellitus Hypertension Obesity Dietary Supplement: Nutritional support system (NSS) Other: Control
MeSH:Hypertension
HPO:Hypertension

Primary Outcomes

Description: Fraction of oxygen-saturated hemoglobin relative to the patient's total blood hemoglobin, represented as a percentage. Measurement using the pulse oximeter of the multi-parameter vital signs monitor. Measurement units % SpO2.

Measure: Oxygen saturation

Time: 1 minute

Description: Balance between the production of heat by the body and its loss. Measurement using an infrared thermometer. Units of measure degrees centigrade.

Measure: Body temperature

Time: 30 seconds

Description: Force exerted by the blood against the walls of the vessels (arteries) as it is pumped by the heart. Measurement using the multi-parameter vital signs monitor. Units of measurement in mmHg. Obtain systolic and diastolic pressure.

Measure: Blood pressure

Time: 2 minutes

Description: Number of times the heart beats for a certain period of time, measured by the multi-parameter vital signs monitor. Units of measure beats per minute.

Measure: Heart rate

Time: 1 minute

Description: Number of breaths that a living being takes during a certain period of time, Count daily with the patient at rest the number of breaths for one minute each time the chest rises. Measured in breaths per minute.

Measure: Breathing frequency

Time: 1 minute

Description: Disruption of the organic functions of any living being. The existence of the death certificate will be reviewed daily. Categories: dead or alive.

Measure: Death

Time: 10 seconds

Description: Simultaneous knowledge, in the unity of time, of oneself (subject) and of the surrounding world (object), is the reflection of reality. It will be evaluated daily with the glasgow scale. Categories: 1.13-15 points. 2. 9-12 points. 3. 3-8 points.

Measure: Awareness

Time: 2 minutes

Description: Number of days that the patient remains hospitalized. It is reviewed daily if the patient has been discharged. Categories: 1.Hopitalized. 2. Released.

Measure: Hospital stay

Time: 10 seconds

Description: Rapid sequential evaluation of organic failures. Evaluate daily the qSOFA items and get your score. Measure in points.

Measure: qSOFA score

Time: 1 minute

Description: Clinically and study-based acquired need to open the airway in order to supply him with oxygen. Check daily if a cannula or tube was placed in the windpipe. Categories: 1.Progress to ventilation. 2. Does not progress to ventilation.

Measure: Progression to ventilation

Time: 10 seconds

Description: Need for a multidisciplinary team, for presenting an acute critical state, with the support of technological resources for monitoring, diagnosis and treatment. It is reviewed daily if the patient is directed to ICU. Categories: 1.Enter ICU. 2. You do not enter ICU.

Measure: Progression to Intensive Care Unit

Time: 10 seconds

Description: Any localized painful discomfort in the head. Evaluate and ask for pain by numbering it from 1-10, where 0 is the absence and 10 is the greatest intensity (Daily, 2 shifts, 21 days).

Measure: Cephalea

Time: 10 seconds

Description: Physical actions that you can take without pain or discomfort. Evaluate what movements and activities he tolerates (Daily, 2 shifts, 21 days). Categories: 1.Walk. 2.He can stand 3.Sit. 4.Postrate.

Measure: Activity level

Time: 10 seconds

Description: Body postures that are used to facilitate the examination of the patient, his treatment, the prevention of injuries due to immobility, and his comfort when he is bedridden. Observe the anatomical position in which he is found (Daily, 2 shifts, 21 days). Categories: 1. In the prone position. 2.In the supine position. 3.Fowler. 4.Semifowler. 5.Other

Measure: Anatomic position

Time: 10 seconds

Description: Evaluate the level of hydration of the hair (Daily, morning, 21 days). Categories: 1.Hydrated, shiny. 2.Opaque. 3.Very dull and dry.

Measure: Hair hydration

Time: 19 seconds

Description: Evaluate hair loss with the "pull sign" by pulling the hair without the intention of plucking, daily in the morning (Daily, morning, 21 days).Categories 1. <5 hairs on hand. 2. 5-10 hairs. 3.> 10 hairs.

Measure: Hair loss

Time: 20 seconds

Description: Targeted search for one or more asymptomatic sudden onset decalvary patches throughout the hair territory (Daily, morning, 21 days). Categories: 1. Without decalvary plates. 2. With regional decalvary plates. 3. Generalized alopecia areata.

Measure: Decalvary patches

Time: 10 seconds

Description: Inspect the scalp for lesions (Daily, morning, 21 days). Categories: 1.No injuries. 2. Flaking. 3.Erythema. 4.Infection. 5. Bleeding.

Measure: Scalp lesions

Time: 15 seconds

Description: Ask about itching of the scalp (Daily, morning, 21 days). Categories: 1.Without itching. 2.Itching.

Measure: Itching scalp

Time: 10 seconds

Description: Evaluate the absence or loss of eyelashes, daily in the morning. Categories: 1.Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Loss of eyelashes

Time: 15 seconds

Description: Evaluate the absence or drooping of eyebrows (Daily, morning, 21 days). Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Drooping of eyebrows

Time: 10 seconds

Description: Evaluate eyelid edema (Daily, morning, 21 days). Categories: 1. Without edema. 2. With edema

Measure: Eyelid edema

Time: 5 seconds

Description: Check the vascularity of the sclera (Daily, morning, 21 days). Categories: 1.White sclera. 2.Small blood vessels. 3. Large blood vessels. 4.Hemorrhage.

Measure: Vascularity of the sclera

Time: 10 seconds

Description: Assess ocular hydration (Daily, morning, 21 days). Categories: 1.Hydrated. 2.Dry mucus. 3.Absence of tears. 4 sunken eyes

Measure: Ocular hydration

Time: 15 seconds

Description: Evaluate sclera color, daily in the morning. Categories: 1.White. 2. Localized yellow. 3.General yellow. 4.Other colors.

Measure: Sclera color

Time: 10 seconds

Description: Evaluation of smell, presenting non-irritating odors and ask if it distinguishes them (Daily, morning, 21 days). Categories: 1.Normal. 2. Hyposmia. 3.Anosmia.

Measure: Sense of smell

Time: 30 seconds

Description: Evaluate the presence of irritation in the nostrils (Daily, morning, 21 days). Categories: 1.No irritation. 2.With irritation.

Measure: Irritation in the nostrils

Time: 10 seconds

Description: Assess nasal secretions (Daily, morning, 21 days). Categories: 1. Absence. 2.Transparent. 3.Of other colors. 4.With blood.

Measure: Nasal secretions

Time: 10 seconds

Description: Evaluate the presence of cheilitis (Daily, morning, 21 days). Categories: 1.Without cheilitis. 2.Unilateral. 3.Bilateral. 4.With ulcers.

Measure: Cheilitis

Time: 5 seconds

Description: Assess taste buds (Daily, morning, 21 days). Categories: 1. Normal. 2. Inflamed. 3. Painful. 4. Bleeding.

Measure: Taste buds

Time: 10 seconds

Description: Evaluate the presence of the saw edge of the tongue (Daily, morning, 21 days). Categories 1.Normal. 2.Flat 3.With serrated edge.

Measure: Saw edge of the tongue

Time: 10 seconds

Description: Look for changes in the body of the tongue (Daily, morning, 21 days). Categories: 1.No alterations. 2.Geographic. 3.Fissured.

Measure: Changes in the body of the tongue

Time: 10 seconds

Description: Look for changes in the thickness of the tongue (Daily, morning, 21 days). Categories: 1. Normal thickness. 2. Abnormal thickness, swollen.

Measure: Thickness of the tongue

Time: 5 seconds

Description: Assess the presence of salivation (Daily, morning, 21 days). Categories: 1.Normal. 2.Excessive salivation. 3 absent.

Measure: Salivation

Time: 10 seconds

Description: Evaluate the taste presenting food from their tray and ask if you distinguish the flavors (Daily, morning, 21 days). Categories: 1.Conserved. 2. Hypogeusia. 3.Ageusia.

Measure: Taste

Time: 30 seconds

Description: Evaluation of the gums (Daily, morning, 21 days). Categories: 1.Normal. 2.Hypersensitive 3.Inflamed. 4. Bleeding.

Measure: Gums

Time: 10 seconds

Description: Evaluation of skin sensitivity (Daily, morning, 21 days). Categories: 1.Normal. 3.Altered sensitivity. 3.Painful.

Measure: Skin sensitivity

Time: 30 seconds

Description: Assess the presence of lesions (Daily, morning, 21 days). Categories: 1. No lesions. 2.Dermatitis. 3. Open lesions.

Measure: Skin lesions

Time: 10 seconds

Description: Assess skin hydration (Daily, morning, 21 days). Categories: 1.Normal. 2.Fat. 3.Dry.

Measure: Skin hydration

Time: 10 seconds

Description: Evaluate skin texture (Daily, morning, 21 days). Categories: 1.Lisa. 2.Rugose. 3.Descamative

Measure: Skin texture

Time: 10 seconds

Description: Check for loss or absence of body hair (Daily, morning, 21 days). Categories: 1.Present. 2.Fall. 3.Absence.

Measure: Absence of body hair

Time: 10 seconds

Description: Evaluate by finger pressure the 7th cervical hypersensitivity (Every 2 days, morning, 21 days). Categories: 1. It does not cause pain. 2. It causes pain.

Measure: Cervical pain points

Time: 5 seconds

Description: Search for hypersensitivity on the inside of the forearm (Every 2 days, morning, 21 days)

Measure: Forearm pain points

Time: 5 seconds

Description: Ask if he presents odynophagia (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Odynophagia

Time: 5 seconds

Description: Evaluation of the presence of cough (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2.Productive. 3.Dry

Measure: Cough

Time: 5 seconds.

Description: Evaluation of the presence of sneezing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Sneezing

Time: 5 seconds

Description: Respiration rhythm evaluation (Daily, 2 shifts, 21 days). Categories: 1. Normal. 2.Altered.

Measure: Respiration rhythm

Time: 1 minute

Description: Assessment of abdominal breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Abdominal breathing

Time: 20 seconds

Description: Evaluation of the use of accessory muscles when breathing (Daily, 2 shifts, 21 days). Categories: 1.Absent. 2. Present.

Measure: Use of accessory muscles when breathing

Time: 10 seconds

Description: Evaluate the presence of xiphoid retraction when breathing (Daily, 2 shifts, 21 days). Categories: 1. Absent. 2. Present.

Measure: Xiphoid retraction when breathing

Time: 10 seconds

Description: Assess the presence and degree of dyspnea (Daily, 2 shifts, 21 days). Categories: 1.Without difficulty. 2.When standing. 3.When sitting. 2.When speaking, 3.Lying down.

Measure: Dyspnea

Time: 10 seconds

Description: Evaluate the abdomino-cutaneous reflexes (Diary, verpertino, 21 days). Categories: 1. Present. 2. Absent

Measure: Abdomino-cutaneous reflexes

Time: 20 seconds

Description: Assess rebound sensitivity (Daily, verpertino, 21 days). Categories: 1. Without sensitivity. 2. With sensitivity.

Measure: Rebound sensitivity

Time: 15 seconds

Description: Evaluate the presence of pain in the right hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right hypochondrium

Time: 5 seconds

Description: Evaluate the presence of pain in the epigastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Epigastrium

Time: 5 seconds

Description: Evaluate the presence of pain in the left hypochondrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left hypochondrium

Time: 5 seconds

Description: Assess the presence of pain in the right flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right flank

Time: 5 seconds

Description: Assess the presence of pain in the mesogastrium (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Mesogastrium

Time: 5 seconds

Description: Evaluate the presence of pain in the left flank. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left flank

Time: 5 seconds

Description: Evaluate the presence of pain in the right iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Right iliac fossa.

Time: 5 seconds

Description: Evaluate the presence of pain in the hypogastrium. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Hypogastrium

Time: 5 seconds

Description: Assess the presence of pain in the left iliac fossa. (Daily, evening, 21 days) Categories: 1. No pain. 2. With pain.

Measure: Left iliac fossa.

Time: 5 seconds

Description: Ask for the presence of vomiting in 24 hours (Daily, evening, 21 days). Categories: 1. Absent. 2. Present.

Measure: Vomiting

Time: 5 seconds

Description: Ask about the presence of appetite (Daily, evening, 21 days). Categories: 1. Increased appetite. 2.Normal 3.Hypoexia. 4.Anorexia.

Measure: Appetite

Time: 5 seconds

Description: Ask about the presence of reflux (Daily, evening 21 days). Categories: 1. Absent. 2. After eating (specify food). 3. At bedtime. 4. Sudden

Measure: Reflux

Time: 5 seconds

Description: Ask about the presence of more common burps than normal (Daily, evening, 21 days). Categories: 1.Normales 2. Augmented.

Measure: Burps

Time: 5 seconds

Description: Evaluation of defecation by means of bowel movements with the Bristol scale (Daily, evening, 21 days). Categories: 1.Normal (T3, T4) 2.Constipation (T1, T2). 3. Diarrhea (T5, T6, T7).

Measure: Bristol scale

Time: 10 seconds

Description: Evaluation of hair loss on legs (Every 2 days, evening, 21 days) Categories: 1. Without alterations. 2.White spaces. 3. Fall when exploring.

Measure: Hair loss on legs

Time: 10 seconds

Description: Evaluation of the sensitivity of the tibial tract (Every 2 days, evening, 21 days) Categories: 1. No pain. 2.Painful.

Measure: Sensitivity of the tibial tract

Time: 10 seconds

Description: Assessment of nail strength (Every 2 days, evening, 21 days). Categories: 1. Strong. 2. Brittle. 3.Not assessable.

Measure: Nail strength

Time: 10 seconds

Description: Check the presence of fungus in the nails of the hands (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: Fungus in the nails of the hands

Time: 10 seconds

Description: Look for the presence of white stripes on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White stripes on the nails

Time: 5 seconds

Description: Look for the presence of white spots on the nails (Every 2 days, evening, 21 days). Categories: 1. Absent. 2. Present. 3.Not assessable.

Measure: White spots on the nails

Time: 5 seconds

Description: Look for the presence of ridges on the nails (Every 2 days, evening, 21 days). Categories: 1.Lisas. 2.With ridges. 3.Not assessable.

Measure: Ridges on the nails

Time: 5 seconds

Description: Taking the height (at the beginning of the protocol). Measure in cm.

Measure: Height

Time: 1 minute

Description: Weight taking (Every 2 days, 2 hours after breakfast, for 21 days). Measured in kg.

Measure: Weight

Time: 1 minute

Description: Calculation of BMI (Every 2 days, morning, for 21 days). Measured in kg / m2.

Measure: BMI

Time: 30 seconds

Description: Measurement by blood sample of erythrocytes (Every 3 days, for 21 days). Measured at 10 ^ 6 / uL.

Measure: Erythrocytes

Time: 20 seconds

Description: Measurement by blood sample of hemoglobin (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin

Time: 20 seconds

Description: Measurement by blood sample of hematocrit (Every 3 days, for 21 days). Measurement in %.

Measure: Hematocrit

Time: 20 seconds

Description: Measurement by blood sample of mean corpuscular volume (MCV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean corpuscular volume

Time: 20 seconds

Description: Measurement by blood sample of mean hemoglobin concentration (Every 3 days, for 21 days). Measurement in pg.

Measure: Mean hemoglobin concentration

Time: 20 seconds

Description: Measurement every 3 days by blood sample of mean corpuscular hemoglobin concentration (Every 3 days, for 21 days). Measured in g / dL

Measure: Mean corpuscular hemoglobin concentration

Time: 20 seconds

Description: Erythrocyte distribution width measurement by blood sample (Every 3 days, for 21 days). Measured in%.

Measure: Erythrocyte distribution width

Time: 20 seconds

Description: Measurement by blood sample of the hemoglobin distribution index (Every 3 days, for 21 days). Measured in g / dL.

Measure: Hemoglobin distribution index

Time: 20 seconds

Description: Measurement by blood sample of leukocytes (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Leukocytes

Time: 20 seconds

Description: Measurement by blood sample of neutrophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Neutrophils (%)

Time: 20 seconds

Description: Measurement by blood sample of neutrophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Neutrophils (#)

Time: 20 seconds

Description: Measurement by blood sample of lymphocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Lymphocytes (%)

Time: 20 seconds

Description: Measurement by blood sample of lymphocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Lymphocytes (#)

Time: 20 seconds

Description: Measurement by blood sample of monocytes (%) (Every 3 days, for 21 days). Measurement in%

Measure: Monocytes (%)

Time: 20 seconds

Description: Measurement by blood sample of monocytes (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Monocytes (#)

Time: 20 seconds

Description: Measurement by blood sample of eosinophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Eosinophils (%)

Time: 20 seconds

Description: Measurement by blood sample of eosinophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Eosinophils (#)

Time: 20 seconds

Description: Measurement by blood sample of basophils (%) (Every 3 days, for 21 days). Measurement in%

Measure: Basophils (%)

Time: 20 seconds

Description: Measurement by blood sample of basophils (#) (Every 3 days, for 21 days). Measured in 10 ^ 3 / μL

Measure: Basophils (#)

Time: 20 seconds

Description: Measurement of prothrombin time (PT) by blood sample (Every 3 days, for 21 days). Measure in seconds

Measure: Prothrombin time

Time: 20 seconds

Description: Measurement by blood sample of INR (Every 3 days, for 21 days). Measure in units

Measure: INR

Time: 20 seconds

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 1

Time: 20 seconds

Description: Measurement by blood sample of partial thromboplastin time (Every 3 days, for 21 days). Measure in seconds

Measure: Partial thromboplastin time

Time: 20 seconds

Description: Measurement by control blood sample (100-50) (Every 3 days, for 21 days). Measure in seconds

Measure: Control blood sample (100-50) 2

Time: 20 seconds

Description: Measurement by blood sample of platelets. Measured in 10 ^ 3 / μL

Measure: Platelets

Time: 20 seconds

Description: Measurement by blood sample of mean platelet volume (MPV) (Every 3 days, for 21 days). Measured in fL.

Measure: Mean platelet volume

Time: 20 seconds

Description: Initial screening test to diagnose patients with signs or symptoms suggestive of venous thromboembolism, it is a marker of endogenous fibrinolysis. Measurement by blood sample of dimer D (Every 3 days, for 21 days). Measured in ng / mL

Measure: D-dimer

Time: 20 seconds

Description: Sulfur amino acid that originates in the metabolism of methionine, and is very aggressive for the arterial endothelium. Measurement by blood sample of homocysteine levels (Every 3 days, for 21 days). Measured in µmol / l.

Measure: Homocysteine

Time: 20 seconds

Description: Fat-soluble vitamin involved in calcium homeostasis and bone metabolism, regulation of genes involved in the regulation of cell proliferation, cell differentiation and apoptosis. It has been suggested that it exerts immunomodulatory and antiproliferative effects. Measurement by blood sample of levels of 25-hydroxycholecalciferol (Every 3 days, for 21 days). Measured in nmol / L

Measure: Vitamin D

Time: 20 seconds

Description: Measurement by blood sample of calcium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Calcium

Time: 20 seconds

Description: Measurement by blood sample of phosphorus (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Phosphorus

Time: 20 seconds

Description: Measurement by blood sample of magnesium (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Magnesium

Time: 20 seconds

Description: Measurement by blood sample of sodium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Sodium

Time: 20 seconds

Description: Measurement by blood sample of potassium (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Potassium

Time: 20 seconds

Description: Measurement by blood sample of chlorine (Every 3 days, for 21 days). Measured in mmol / L.

Measure: Chlorine

Time: 20 seconds

Description: A measure of the concentration of free glucose in the blood, serum or blood plasma. Measured in mg / dL.

Measure: Blood glucose

Time: 20 seconds

Description: Taking a blood sample of total cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total cholesterol

Time: 20 seconds

Description: Taking a blood sample of triglycerides (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Triglycerides

Time: 20 seconds

Description: Taking a blood sample of LDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: LDL cholesterol

Time: 20 seconds

Description: Taking a blood sample for HDL cholesterol (Every 3 days, for 21 days). Measured in mg / dL.

Measure: HDL cholesterol

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of aspartate aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Aspartate aminotransferase

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of alanine aminotransferase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alanine aminotransferase

Time: 20 seconds

Description: Taking a blood sample to evaluate the total bilirubin level (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Total bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of direct bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Direct bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of indirect bilirubin (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Indirect bilirubin

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of alkaline phosphatase (Every 3 days, for 21 days). Measured in U / L.

Measure: Alkaline phosphatase

Time: 20 seconds

Description: Taking a blood sample to evaluate the level of total proteins (Every 3 days, for 21 days). Measured in g / dL.

Measure: Total proteins

Time: 20 seconds

Description: Taking a blood sample to evaluate the albumin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Albumin level

Time: 20 seconds

Description: Taking a blood sample to evaluate the globulin level (Every 3 days, for 21 days). Measured in g / dL.

Measure: Globulin level

Time: 20 seconds

Description: Taking a blood sample to evaluate the A / G ratio (Every 3 days, for 21 days). Measured in g / dL.

Measure: A / G ratio

Time: 20 seconds

Description: ake a blood sample to evaluate the levels of urea nitrogen (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea nitrogen

Time: 20 seconds

Description: Take a blood sample to evaluate urea levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Urea

Time: 20 seconds

Description: Take a blood sample to evaluate creatitine levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Creatitine

Time: 20 seconds

Description: Take a blood sample to evaluate uric acid levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Uric acid

Time: 20 seconds

Description: Take a blood sample to evaluate ferritin levels (Every 3 days, for 21 days). Measured in ng/mL.

Measure: Ferritin

Time: 20 seconds

Description: Take a blood sample to evaluate fibrinogen levels (Every 3 days, for 21 days). Measured in mg / dL.

Measure: Fibrinogen

Time: 20 seconds

Description: Take a blood sample to evaluate the levels of C-reactive protein (Every 3 days, for 21 days). Measured in mg/L.

Measure: C-reactive protein

Time: 20 seconds

Description: Use of the appropriate procedures established in the NSS indications (Specific supplementation scheme, based on 1 sachet, intramuscular B vitamins and probiotics). Quantification of empty supplement envelopes (Daily, 2 shifts, 21 days). Categories: 1.On empty. 2. About half. 3.Full.

Measure: Adherence to the Nutritional Support System (NSS)

Time: 5 seconds

Description: Quantification of the time from when the envelope is added in water, until everything is consumed (Daily, 2 shifts, 21 days). Categories: 1. Less than 15 minutes. 2. More than 15 minutes.

Measure: Intake time

Time: 15 minutes

Description: Quantification of the amount of prepared "NSS" he drink (Daily, 2 shifts, 21 days). Categories: 1.All the preparation. 2.Half. 3.Nothing.

Measure: Amount of prepared "NSS" he drink

Time: 15 minutes

Description: In-person verification of the taking of the floratil pill and observe that they do not vomit it (Daily, 2 shifts, first 6 days). Categories: 1. The pill is taken. 2.The pill is not taken.

Measure: Taking of the "floratil" pill

Time: 20 seconds

Description: Corroborate in person the correct application of the neurobion injection (Daily, evening, first 5 days). Categories: 1. It applies. 2.Not applicable.

Measure: Neurobion injection

Time: 1 minute

Description: Unit of thermal energy, which is equal to the amount of heat needed to raise the temperature of 1 gram of water by 1 degree Celsius. Unit of measurement of the energy content of food that consists of the number of calories that a given weight of food can develop in the tissues, or in the physical work equivalent to them. Calculate the grams that the food has of each macronutrient and multiply it by the energy intake. Based on the Mexican Equivalent Food System. Number in Kcal.

Measure: Diet calories

Time: 15 minutes

Description: Evaluate the amount of trans fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Trans fat in the diet

Time: 2 minutes

Description: Evaluate the amount of saturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Saturated fat in the diet.

Time: 2 minutes

Description: Evaluate the amount of monounsaturated fats in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Monounsaturated fats in the diet

Time: 2 minutes

Description: Evaluate the amount of polyunsaturated fat in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Polyunsaturated fat in the diet

Time: 2 minutes

Description: Evaluate the amount of protein of animal origin in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Protein of animal origin in the diet

Time: 2 minutes

Description: Evaluate the amount of plant-based protein in the diet. (Daily, 2 shifts, 21 days). Based on the Mexican Equivalent Food System. Number in g.

Measure: Plant-based protein in the diet

Time: 2 minutes

Description: Accurate record of the amount of fluids administered. Evaluate the income of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (income)

Time: 5 minutes

Description: Accurate record of the amount of liquids eliminated by any means. Evaluate the expenses of 24 hrs. (Daily, 2 shifts, 21 days). Number in ml.

Measure: Fluid balance (outcome)

Time: 5 minutes

Description: Need or desire to eat. Observe the percentage of the tray with food that was ingested (Daily, 2 shifts, 21 days). Categories: 1. 100% ingested. 2.75%. 3.50%. 4.25%.

Measure: Hungry

Time: 15 seconds

Description: Cardiovascular disease risk indicator. Measure with a tape measure with the patient standing, feet together, arms at the sides and the abdomen relaxed, encircling the abdomen at the level of the navel at the midpoint between the last rib and the iliac crest and without pressing, taking an inspiration deep, taking the measurement at the moment of expelling the air.

Measure: Abdominal circumference

Time: 1 minute

Description: It is used to know the nutritional status of the patient. It is obtained by measuring the middle part of the arm with a tape measure, taking as a reference the length between the point of the shoulder (acromion) and the head of the radius (olecranon). Take the circumference of the arm using a tape measure (every 2 days, 2 hours after breakfast, in the morning, for 21 days). Measure in mm.

Measure: Arm circumference.

Time: 3 minutes

Description: It is measured on the midline of the back of the arm (triceps) at 1 cm from the height of the midpoint of the arm. Taking triceps fold measuring tape and caliper (every 2 days, 2 hours after breakfast, morning, for 21 days)). Measure in mm.

Measure: Tricipital fold

Time: 3 minutes

Description: Calculation from arm circumference and triceps fold. Calculate it according to the formula proposed by Frisancho. (every 2 days, 2 hours after breakfast, morning, for 21 days). Measure in mm2.

Measure: Arm area

Time: 1 minute

Description: Set of peculiarities that characterize the individuals of a species, dividing them into male and female, and make possible a reproduction characterized by genetic diversification. Based on an official ID. Categories: 1. Male 2. Female

Measure: Biological sex

Time: 30 seconds

Description: Time elapsed from the birth of a living being to the moment the calculation is made. Based on an official ID. Number between 30 and 75.

Measure: Age

Time: 30 seconds

Description: Sugars attached to the surface of red blood cells, and according to their composition. Evaluate by blood sample. Categories: 1.A, 2. B, 3.AB 4.O.

Measure: AB0 system

Time: 2 minutes

Description: Protein in red blood cells or erythrocytes. Obtaining by blood sample. Categories: 1.Rh (+) 2.Rh (-).

Measure: Rh factor

Time: 2 minutes

Secondary Outcomes

Description: Record the use of proton pump inhibitors (omeprazole, pantoprazole) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of proton pump inhibitors

Time: 5 seconds

Description: Record the use of obesity medications (orlistat, acarbose, bile acid sequestrants, etc.) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Obesity medications

Time: 5 seconds

Description: Record the use of antiepileptic drugs (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antiepileptic drugs

Time: 5 seconds

Description: Record the use of oral contraceptives (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of oral contraceptives

Time: 5 seconds

Description: Record the use of antimitotics (colchicine) (daily, evening, for 21 days). Categories: 1.Not prescribed. 2.Prescribed.

Measure: Use of antimitotics

Time: 5 seconds

Description: Chemical substance that kills or prevents the growth of certain classes of sensitive microorganisms. Record the antibiotics that are being administered. (daily, evening, for 21 days) Categories: 1.Not used. 2.Use of antibiotics (specify which)

Measure: Antibiotics

Time: 5 seconds

Description: Medicines whose main pharmacological effect is to relieve pain. Record the analgesics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of analgesics (specify which)

Measure: Analgesics

Time: 5 seconds

Description: Drugs with anti-inflammatory and immunosuppressive effect. Record the corticosteroids that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of corticosteroids (specify which).

Measure: Corticosteroids

Time: 5 seconds

Description: Substance that causes the elimination of water and electrolytes from the body through urine. Record the diuretics that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of diuretics (specify which)

Measure: Diuretics

Time: 5 seconds

Description: Drugs used to lower blood pressure. Record the antihypertensive drugs that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of antihypertensives (specify which)

Measure: Antihypertensive

Time: 5 seconds

Description: Endogenous or exogenous substance that interferes with or inhibits blood clotting, creating an antithrombotic or prohemorrhagic state. Record the anticoagulants that are being administered (daily, evening, for 21 days). Categories: 1.Not used. 2.Use of anticoagulants (specify which)

Measure: Anticoagulants

Time: 5 seconds

Description: Medications that attend to a basic pathology and have not been considered in the previous variables. Record the medications that are being administered and have not been named before (daily, evening, for 21 days). Write the medications.

Measure: Other medications

Time: 5 seconds

Description: Disturbance of the normal state of the level of absorption acutely due to a pathological alteration. Record the acute alterations that affect the absorption of nutrients (daily, evening, for 21 days). Categories: 1.None. 2.Intolerance. 3. Allergies 4. Diarrhea 5. Infection or inflammation in any organ of the digestive system.

Measure: Acute alterations in the absorption of nutrients.

Time: 5 seconds

Description: Any alteration in the response to the action of the drug due to the concomitant reaction of another chemical substance. Side effects reported through the clinic and laboratory (daily, evening, for 21 days). Categories: 1.None. 2.Rash. 3.Head or dizziness. 4.Gastrointestinal pain. 5.Other (specify).

Measure: Drug interactions and adverse effects

Time: 5 seconds

Description: Artificial supply of oxygen (O2) in the inspired air; its main objective is tissue oxygenation. Check the quantity of liters that you have pre-written for 24 hours (daily, evening, for 21 days). Number of liters.

Measure: Oxygen therapy

Time: 5 seconds

Description: Attitude or disposition in emotional life. It is not a transitory emotional situation. It is a state, a way of staying, of being, whose duration is prolonged and fades over the rest of the psychic world. Assess the patient's state of mind (daily, evening, for 21 days). Categories: 1.Happy. 2.Relaxed. 3. Alert. 4. Annoying 5. Sad. 6.Tense. 7.Tired. 8.Depressed

Measure: Mood

Time: 5 seconds


Related HPO nodes (Using clinical trials)


HP:0000822: Hypertension
Genes 411
PLIN1 SMARCAL1 LIMK1 SDCCAG8 ELP1 TSC2 FMR1 CPOX GNAS COX1 SH2B3 LYZ CLCN2 NF1 NOTCH3 ARL6 EDA2R ELN APOA1 CTLA4 CC2D2A MLX FGFR2 ADA2 TRNC MMP14 MTRR BANF1 GLA TRNK TRNL1 CCR6 GPC3 CYP11B2 ERCC8 TRIM32 CFH ACVRL1 COL3A1 LRP6 TRNK XYLT2 CFI CALR ITGA8 SLC37A4 SUGCT GBA NF1 CD46 WT1 WRN KLHL3 BBS4 THPO SDHA POU6F2 ABCG8 CORIN NFIX PDE8B NOD2 ARVCF INVS PRKAR1A RET GLA SLC25A11 SCNN1A TRIM28 TRNQ OFD1 B2M WT1 TNFRSF11B ARMC5 FGFR2 HLA-DPB1 PPARG EDA TP53 BNC2 ALX4 LMX1B NPHP1 ACAT1 ACTA2 GNAS GTF2IRD1 SDHC UFD1 ENPP1 GATA5 LEMD3 MYH11 HGD SDHD RET RFC2 IRF5 KCNJ5 LDLR ERCC6 DLST REST CAV1 GANAB BBS10 SMAD3 TET2 TRNW MUC1 POU3F4 OFD1 ADA2 SDHB ERCC4 BBS9 CD2AP LMNA CYP11B1 MEF2A MMP2 CLIP2 COL4A3 ELN COMT HPSE2 BBS2 XYLT1 PRKACA JMJD1C SMAD4 VANGL1 G6PC WNK4 DIS3L2 TMEM70 HBB ENPP1 MAFB LZTFL1 TRNS2 PKD2 USP8 HIRA TRIP13 DNAJB11 FBN1 TGFBR1 CFHR1 SH2B3 PKD1 LMNA PRKAR1A SDHB SCN2B PRTN3 NR3C2 WDR35 MDH2 DNMT3A ELP1 ALMS1 ELN TRNL1 IQCB1 RET MKKS YY1AP1 LARS2 AIP TBX1 TGFBR2 SPRY2 FBN1 NOTCH1 ABCB6 PRKACA MTTP MYLK ARL6 ABCC6 TRAF3IP1 COL5A2 RET STOX1 H19 LEMD3 FGA TMEM67 SEC24C MAX CYP11B1 SLC25A11 ND6 KIF1B ACTN4 ADA2 HSD11B2 DYRK1B NPHP1 BMPR2 PDE3A ND1 TTC8 JAK2 MGP NOTCH2 VHL SDHB SDHAF2 VHL MYMK NPHP3 ABCC6 TGFBR3 PPARG ALMS1 SMAD6 TRPC6 CCDC28B TMEM127 VHL TNFRSF11A SCNN1B BBS5 SCNN1B ARHGAP31 APOB SDHD SDHD PDE3A GDNF RREB1 CYP11B1 ECE1 TMEM237 TRNE SDHC FH YY1AP1 LMNA TGFB2 COX3 GPR101 CYP17A1 BRCA2 THBD LMX1B WNK1 LRIG2 FIG4 CEP290 HLA-DRB1 XPNPEP3 CCND1 MKS1 ACTA2 FUZ COL4A3 CYTB SMAD4 LMNA TRNV SLC2A10 FBN1 PRKG1 COQ7 MLXIPL KIF1B AIP FLT1 SERPINA6 CFB PLIN1 HLA-B NKX2-5 WT1 PKD1 EGFR MC4R EPAS1 SLC2A10 GCH1 BAZ1B NSMCE2 VHL PCSK9 KRT8 WT1 WDPCP TRNK PKD2 APRT HLA-DPA1 MPL COL4A5 KCTD1 SDHD TRIM28 GP1BB THSD1 BBS12 CEP290 FMO3 CYP21A2 CUL3 NPHP4 PKHD1 BICC1 COL4A4 BSCL2 NR3C1 WT1 GANAB C3 COX2 TRNF IFT27 GTF2I STAT1 SDCCAG8 PAM16 MFAP5 LOX IL12B SLC37A4 LDLRAP1 MYH7 BBS7 TGFB3 CBS ARMC5 CEP164 ADAMTSL4 INVS CDH23 COL5A1 CACNA1D LMNA PTPN22 SCNN1A SDHB ABCG5 TBX1 FN1 TMEM127 BBS1 CYP17A1 FN1 RPGRIP1L AIP PHF21A CACNA1H POR ND5 ENG BBS1 PDE11A EXT2 COL1A1 GUCY1A1 TSC1 FBN1 TBL2 HMBS HMBS C8ORF37 NR3C1 FOXF1 PRKAR1A NPHP1 CEP19 KRT18 MAX ABCC6 VAC14 KIF1B KCTD1 TRNS1 HSD11B2 GJA1 SCNN1G KCNJ5 BBIP1 PDE11A ANGPTL6 CDH23 KCNJ5 MAT2A SMAD4 IDUA IFT172 CACNA1D WDR19 ZMPSTE24 CYP11B1 FOXE3 CCN2 GNAS SCNN1G GUCY1A1 NFU1 VHL USP8 CFHR3 NOS3 COL3A1 JAK2 OSGEP