Covid 19 Research using Clinical Trials (Home Page)
ControlWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1016 | Growth Mindset Wiki | 0.38 |
| drug983 | Gait Retraining Wiki | 0.38 |
| drug1299 | Ketotifen 1 MG Wiki | 0.38 |
| drug246 | Auricular neuromodulation Wiki | 0.38 |
| drug1317 | LY3832479 Wiki | 0.38 |
| drug826 | Educational outreach Wiki | 0.38 |
| drug244 | Audit and Feedback Wiki | 0.38 |
| drug1783 | Peginterferon Lambda-1A Wiki | 0.27 |
| drug2662 | Vitamin C Wiki | 0.23 |
| drug1911 | Probiotic Wiki | 0.22 |
| drug2196 | Sargramostim Wiki | 0.22 |
| drug1822 | Placebo Wiki | 0.02 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001988 | Bronchiolitis NIH | 0.38 |
| D001987 | Bronchiectasis NIH | 0.27 |
| D020370 | Osteoarthritis, Knee NIH | 0.22 |
| D001943 | Breast Neoplasms NIH | 0.19 |
| D014777 | Virus Diseases NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
Correlated HPO Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0011950 | Bronchiolitis HPO | 0.38 |
| HP:0002110 | Bronchiectasis HPO | 0.27 |
| HP:0005086 | Knee osteoarthritis HPO | 0.22 |
| HP:0003002 | Breast carcinoma HPO | 0.19 |
There are 7 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 daysSecondary 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 28Description: Mortality at 6 months
Measure: Number of participants deceased at 6 months Time: 6 monthsDescription: 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 monthsDescription: Assessed by serum lactate concentration
Measure: Global tissue dysoxia Time: Days 1, 3, 7Description: 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, 28Description: 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, 7Description: Assessed by procalcitonin (PCT)
Measure: Rate of infection Time: Days 1, 3, 7Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2)
Measure: Rate of endothelial injury Time: Days 1, 3, 7Description: Assessed by KDIGO (Kidney Disease: Improving Global Outcomes) criteria
Measure: Occurrence of stage 3 acute kidney injury Time: Up to day 28Description: 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 28Description: 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 doseDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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: baselineSecondary 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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: baselineOther 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: baselineDescription: 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: baselineDescription: 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: baselineDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 months3 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.
Primary Outcomes
Description: # of participants screened per month
Measure: Recruitment rate Time: through study completion, an average of 2 yearsDescription: # of participants enrolled per month
Measure: Enrollment rate Time: through study completion, an average of 2 yearsDescription: % participants that complete all study visits
Measure: Retention Time: through study completion, an average of 2 yearsSecondary 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 yearsDescription: Proportion of participants with AE/UP
Measure: Adverse events (AE)/Unanticipated problems (UP) Time: through study completion, an average of 2 yearsDescription: 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-monthDescription: 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-monthDescription: WOMAC questionnaire, pain sub scale 0-20
Measure: Knee Pain with Activities Time: Change from baseline to conclusion of intervention, an average of 1-monthDescription: Visual analog scale, 0-100
Measure: Knee Pain Severity Time: Change from baseline to conclusion of intervention, an average of 1-monthDescription: Assessed using hand held algometer
Measure: Pressure pain threshold Time: Change from baseline to conclusion of intervention, an average of 1-monthPhase 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 periodSecondary Outcomes
Measure: Incidence of AE (Adverse Event) Time: at end of 5 day treatment period, 10 day period, 10-20 weeksMeasure: 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 weeksMeasure: 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 intervention6 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 weeksSecondary 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: 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 weeksDescription: Use of drugs (dosis and duration of the treatment) for Covid-19 treatment
Measure: Medical treatment Time: 8 weeks7 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 daysSecondary 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 daysDescription: Number of study days in ICU without persistant organ dysfunction
Measure: Persistent organ dysfunction-free days in ICU Time: Assessed at 28 daysDescription: Mortality at 6 months
Measure: Number of patients deceased at 6 months Time: 6 monthsDescription: 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 monthsDescription: 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, 28Description: Assessed by serum lactate concentration
Measure: Global tissue dysoxia Time: Days 1, 3, 7Description: 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, 7Description: Assessed by procalcitonin (PCT).
Measure: Rate of infection Time: Days 1, 3, 7Description: Assessed by thrombomodulin (TM) and angiopoietin-2 (ANG-2).
Measure: Rate of endothelial injury Time: Days 1, 3, 7Description: Assessed by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Measure: Occurrence of stage 3 acute kidney injury Time: Up to day 28Description: 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
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.