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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1819 | Hydroxychloroquine, Azithromycin Wiki | 0.27 |
| drug1820 | Hydroxychloroquine, Clindamycin Wiki | 0.27 |
| drug3897 | Tacrolimus Wiki | 0.27 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4794 | unfractionated heparin Wiki | 0.27 |
| drug1821 | Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki | 0.27 |
| drug3436 | SARS-CoV-2 rS/Matrix M1-Adjuvant Wiki | 0.27 |
| drug1964 | Interferon-Alpha2B Wiki | 0.27 |
| drug1071 | Cooking Training Wiki | 0.27 |
| drug3896 | Table Setting Training Wiki | 0.27 |
| drug1057 | Convalescent Serum Wiki | 0.27 |
| drug1822 | Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki | 0.27 |
| drug1823 | Hydroxychloroquine, Doxycycline Wiki | 0.27 |
| drug2128 | Licensed seasonal influenza vaccine Wiki | 0.27 |
| drug2443 | Multi-tasking Training Wiki | 0.27 |
| drug3618 | Siltuximab Wiki | 0.15 |
| drug1712 | Heparin Wiki | 0.15 |
| drug4744 | standard care Wiki | 0.13 |
| drug2176 | Losartan Wiki | 0.09 |
| drug4168 | Usual Care Wiki | 0.09 |
| drug1193 | Dexamethasone Wiki | 0.09 |
| drug4025 | Tocilizumab Wiki | 0.09 |
| drug1396 | Enoxaparin Wiki | 0.07 |
| drug3319 | Remdesivir Wiki | 0.05 |
| drug2916 | Placebo Wiki | 0.03 |
| drug1775 | Hydroxychloroquine Wiki | 0.03 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014029 | Tobacco Use Disorder NIH | 0.13 |
| D011014 | Pneumonia NIH | 0.13 |
| D060825 | Cognitive Dysfunction NIH | 0.07 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011024 | Pneumonia, Viral NIH | 0.06 |
| D018450 | Disease Progression NIH | 0.06 |
| D055370 | Lung Injury NIH | 0.05 |
| D002318 | Cardiovascular Diseases NIH | 0.05 |
| D014947 | Wounds and Injuries NIH | 0.05 |
| D016638 | Critical Illness NIH | 0.03 |
| D013577 | Syndrome NIH | 0.02 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| D007239 | Infection NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002090 | Pneumonia HPO | 0.13 |
| HP:0001268 | Mental deterioration HPO | 0.07 |
| HP:0001626 | Abnormality of the cardiovascular system HPO | 0.05 |
Navigate: Correlations HPO
There are 14 clinical trials
In community acquired pneumonia, corticosteroids have been shown to have potential benefit. However, the limited and variable use of adjunctive corticosteroids in critically ill patients is largely due to an inability to identify patients that will benefit from the use of anti-inflammatory medications. This study compares usual care to a novel biomarker-tailored steroid dosing algorithm for patients with community acquired pneumonia. In April 2020, in response to the SARS CoV-2 pandemic, we added a COVID-19 arm to this study. The study will evaluate the role of biomarker-titrated adjuvant corticosteroid administration compared to usual care in patients admitted to hospital with SARS CoV-2 (COVID-19) infection and acute respiratory failure.
Description: A percentage of eligible patients adhered to the timely initiation (within 12 hours of emergency room admission) and daily corticosteroid treatment according to ESICM/SCCM clinical practice guideline (control group) or biomarker concordance (intervention group)
Measure: Feasibility of the timely initiation of corticosteroids and implementation of biomarker-titrated corticosteroid dosing: percentage of eligible patients adhered to the timely initiation Time: Within 30 days of enrollment in study.Description: Death from any cause
Measure: Mortality Time: Within 30 days and 90 days of study enrollmentDescription: Progression of disease is defined by the need for high flow nasal cannula oxygen, noninvasive or invasive ventilation. Given the proliferation of high flow nasal cannula oxygen use in lieu of mechanical ventilation, instead of ventilator-free days the investigators opt for using advanced respiratory support free days where "advanced respiratory support" includes both invasive and noninvasive mechanical ventilation and the high flow nasal cannula oxygen.
Measure: Progression of disease Time: Within hospitalization or 30 days of study enrollment (whichever is sooner)Description: Measured by respiratory component of SOFA at time of ICU admission, after 24 hours, after 48 hours and after 72 hours and by the organ failure free days. In the absence of daily arterial blood gas analysis, PaO2/FiO2 ratio will be replaced by SpO2/FiO2 ratio
Measure: Evolution of respiratory failure Time: Within 72 hours of enrollment in study.Description: Assessed by renal component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no renal failure and 4 indicating severe renal failure).
Measure: Evolution of kidney failure Time: Within 72 hours of enrollment in study.Description: Assessed by cardiac component of Sequential Organ Failure Assessment (SOFA) Score score. This is a scale from 0-4 (with 0 indicating no cardiovascular failure and 4 indicating severe cardiovascular failure).
Measure: Evolution of shock Time: Within 72 hours of enrollment in study.Description: In hospital and in ICU
Measure: Length of stay Time: From time of study enrollment up to discharge from hospital, to a maximum of 1 year.Description: Number of participants who have hyperglycemia while receiving corticosteroids. Hyperglycemia is defined as a consistently elevated blood sugar level requiring insulin administration.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Hyperglycemia Time: Up to day +5 following study enrollment.Description: Number of participants who develop delirium while receiving corticosteroids. Delirium will be assessed by Confusion Assessment Method for the ICU (CAM-ICU) measurement tool. The CAM-ICU is a binary (yes/no) scale for assessing the presence of delirium.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Delirium Time: Up to day +5 following study enrollment.Description: Number of participants who develop secondary infections during and after steroid therapy. A secondary infection is defined as a new infection that develops after initiation of corticosteroid therapy, until 5 days after steroids are discontinued.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Secondary Infection Time: Up to day +14 following study enrollment.At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
Description: For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Measure: Rate of disease remission Time: day 7Description: the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Measure: Rate and time of entering the critical stage Time: day 7Description: Rate of patients without fever at day 7
Measure: Rate of normal tempreture Time: day 7Description: Rate of patients with respiratory symptom remission at day 7
Measure: Rate of respiratory symptom remission Time: day 7Description: Rate of patients with lung imaging recovery at day 7
Measure: Rate of lung imaging recovery Time: day 7Description: Rate of patients with laboratory indicator recovery at day 7
Measure: Rate of laboratory indicator recovery Time: day 7Description: Rate of patients withundetectable viral RNA at day 7
Measure: Rate of undetectable viral RNA Time: day 7At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
Description: For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Measure: Rate of disease remission Time: day 7Description: the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Measure: Rate and time of entering the critical stage Time: day 7Description: Rate of patients without fever at day 7
Measure: Rate of normal tempreture Time: day 7Description: Rate of patients with respiratory symptom remission at day 7
Measure: Rate of respiratory symptom remission Time: day 7Description: Rate of patients with lung imaging recovery at day 7
Measure: Rate of lung imaging recovery Time: day 7Description: Rate of patients with laboratory indicator recovery at day 7
Measure: Rate of laboratory indicator recovery Time: day 7Description: Rate of patients withundetectable viral RNA at day 7
Measure: Rate of undetectable viral RNA Time: day 7There is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. This is a prospective randomized controlled trails. The aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.
Description: The clinical symptoms and signs continue to deteriorate, or new pulmonary or extrapulmonary lesions appear, or the chest imaging indicates the progress, and the patient is transferred to ICU or intubation and invasive ventilation or died.
Measure: the incidence of treatment failure in 14 days Time: 14 daysDescription: The clinical symptoms and signs improved or alleviated (the temperature be normal , respiratory symptoms improved significantly, imaging showed obvious absorption) and no additional or alternative treatment was needed.
Measure: clinical cure incidence in 14 days Time: 14 daysDescription: the duration from admission to virus negative
Measure: the duration of virus change to negative Time: 30 daysDescription: the patient die in 30 days
Measure: mortality at day 30 Time: 30 daysDescription: the patients transform to ICU because of clinical deteriorate in 30 days
Measure: ICU admission rate in 30 days Time: 30 daysCOVID-19 infection is overwhelming Italian healthcare. There is an urgent need for a solution to the lack of ICU beds and increasing deaths day after day. A recent retrospective Chinese paper (JAMA Intern Med, online March 13, 2020) showed impressive positive effect of methylprednisolone (MP) on survival of SARS-CoV-2 critically ill patients. Moreover, the Italian Infectious Disease leading institution guidelines for COVID-19 clinical management included as an option for patients with "incipient worsening of respiratory functions" methylprednisolone treatment at an approximate dose of 80mg. The main objective of this multi-centre observational trial is to analyse the association of low dose prolonged infusion of methylprednisolone (MP) for patients with severe acute respiratory syndrome with composite primary end-point (ICU referral, need for intubation, in-hospital death at day 28).
Description: We reported below the number of participants meeting at least one of three among death or ICU admission or Invasive mechanical ventilation.
Measure: Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation (MV), or All-cause Death by Day 28 Time: 28 daysDescription: We reported below the number of participants who died within 28 days, during the hospital stay.
Measure: In-hospital Death Within 28 Days Time: 28 daysDescription: We reported below the number of participants admitted to ICU within 28 days.
Measure: Admission to Intensive Care Unit (ICU) Time: 28 daysDescription: We reported below the number of participants who needed endotracheal intubation during ICU admission
Measure: Endotracheal Intubation (Invasive Mechanical Ventilation) Time: 28 daysDescription: Change in C-reactive protein after 7 days from baseline. A reduction of CRP reveals a laboratory improvement.
Measure: Change in C-reactive Protein (CRP) Time: 7 daysDescription: number of days free from mechanical ventilation (both invasive and non-invasive) by day 28
Measure: Number of Days Free From Mechanical Ventilation Time: 28 daysIn our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.
The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury.
Description: Assess the days until clinical stability is achieved after initiating randomization in hospitalized patients with elevated inflammatory parameters and severe COVID-19 lung injury. Clinical stability is defined if all the following criteria are met for 48 consecutive hours: Body temperature ≤ 37.0ºC; PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300; Respiratory rate ≤ 24 rpm
Measure: Time to reach clinical stability Time: 28 daysDescription: days
Measure: Time to reach an afebrile state for 48 hours. Time: 56 daysDescription: days
Measure: Time to reach PaO2 / FiO2> 400 and / or SatO2 / FiO2> 300 Time: 56 daysDescription: days
Measure: Time to reach FR ≤ 24 rpm for 48 hours Time: 56 daysDescription: days
Measure: Time to normalization of D-dimer (<250 ug / L) Time: 56 daysDescription: days
Measure: Time until PCR normalization (<5mg / L). Time: 56 daysDescription: days
Measure: Time until normalization of ferritin (<400ug / L) Time: 56 daysDescription: viral load
Measure: Study the impact of immunosuppressive treatment on viral load using quantitative PCR Time: 56 daysDescription: days
Measure: Time until hospital discharge Time: 56 daysDescription: days
Measure: Need for ventilatory support devices Time: 56 daysDescription: days
Measure: Duration that it is necessary to maintain ventilatory support. Time: 56 daysDescription: days
Measure: COVID-19 mortality Time: 56 daysDescription: days
Measure: all-cause mortality Time: 56 daysDescription: cytokines quantification technique by Luminex
Measure: Analyze the expanded cytokine profile before the start of treatment and their evolution every 7 days after admission Time: 56 daysDescription: IDIBELL Clinical Research and Clinical Trials Unit will oversee the monitoring and pharmacovigilance
Measure: Describe the side effects and their severity attributed to tacrolimus and / or methylprednisolone. Time: 56 daysThis study aims to compare the efficacy and safety of Methylprednisolone versus Tocilizumab in improving clinical outcomes and reducing the need for ventilator support in COVID-19 patients with moderate COVID-19 disease at risk for complications of cytokine storm. Approximately 310 participants hospitalized with COVID-19 in UMMC, Hospital Sungai Buloh, Hospital Kuala Lumpur and Hospital Tuanku Jaafar will be enrolled into this study. Eligible participants will be selected based on a set of clinical, laboratory and radiological parameters indicative of early stages of CRS and lung function decline prior to being randomized at a ratio of 1:1 to receive either Tocilizumab or Methylprednisolone. Participants will be monitored daily for clinical and laboratory parameters, and at 48 hours, switched to the alternate study arm should they manifest signs and symptoms indicative of decompensation.
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging, measurement of serum markers of disease, and sampling of tissue. In each of these instances, there is a built in error either due to sensitivity and specificity issues, clinician interpretation of results, or acceptance of the use of an indirect marker (blood test) of what is happening elsewhere in the body - at the tissue level. The Fleming Method for Tissue and Vascular Differentiation and Metabolism (FMTVDM) using same state single or sequential quantification comparisons [1] provides the first and only patented test (#9566037) - along with the associated submitted patent applications ruled to be covered under #9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process. This includes inter alia coronary artery disease (CAD), cancer and infectious/inflammatory processes including CoVid-19 pneumonia (CVP) resulting from the metabolic and regional blood flow differences (RBFDs) caused by these diseases. The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient, directing treatment decisions; thereby reducing the loss of time, money, resources and patient lives.
Description: Measured improvement in tissue as measured using FMTVDM
Measure: Improvement in FMTVDM Measurement with nuclear imaging. Time: 72 hoursDescription: Extubation
Measure: Ventilator status Time: 7 daysDescription: Self explanatory
Measure: Survival status Time: 30 daysThe investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.
Description: Number of patients transferred to ICU is each of the groups
Measure: Transfer to Intensive care unit (ICU) Time: 14 days followup for every patient in each groupDescription: Number of patients that needed mechanical ventilation in each of the groups
Measure: Need for Mechanical Ventilation Time: 14 days followup for every patient in each groupDescription: Number of patients who died in each of the groups
Measure: Mortality Time: 14 days followup for every patient in each groupDescription: Number of patients who developed ARDS of varying severity per Berlin classification in each of the groups
Measure: Development and Severity of ARDS Time: 14 days followup for every patient in each groupDescription: LOS in each of the groups
Measure: Length of hospital stay (LOS). Time: 14 days followup for every patient in each groupAround 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.
Description: • Death
Measure: Proportion of patients developing treatment failure Time: At 14 days after randomizationDescription: • Need for admission in an intensive care unit (ICU)
Measure: Proportion of patients developing treatment failure Time: At 14 days after randomizationDescription: • Need for mechanical ventilation
Measure: Proportion of patients developing treatment failure Time: At 14 days after randomizationDescription: • Decrease in SpO2 <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, associated with radiological impairment
Measure: Proportion of patients developing treatment failure Time: At 14 days after randomizationDescription: Time in days from randomization until the date of hospital discharge.
Measure: Length of hospital stay Time: At 28 days after randomizationDescription: Any undesirable experience related to the use of the studied drugs, which causes patient's death, life-threatening risk, hospitalization or extension of a previous hospitalization, disability or permanent damage, requires intervention to prevent permanent impairment or damage, or is considered medically relevant
Measure: Proportion of severe adverse events Time: At 28 days after randomizationDescription: Change in plasma levels of C-reactive protein (CRP)
Measure: Evolution of inflammatory biomarkers related to COVID-19 Time: At 14 days after randomizationDescription: Change in plasma levels of ferritin
Measure: Evolution of inflammatory biomarkers related to COVID-19 Time: At 14 days after randomizationDescription: Change in plasma levels of interleukin-6 (IL-6)
Measure: Evolution of inflammatory biomarkers related to COVID-19 Time: At 14 days after randomizationDescription: Change in plasma levels of lactate dehydrogenase (LDH)
Measure: Evolution of inflammatory biomarkers related to COVID-19 Time: At 14 days after randomizationDescription: Change in plasma levels of D-dimer (DD)
Measure: Evolution of inflammatory biomarkers related to COVID-19 Time: At 14 days after randomizationDescription: Negativization of RT-PCR for SARS-CoV-2 on nasopharyngeal swab or sputum
Measure: Proportion of SARS-CoV-2 clearance. Time: At 7 days after randomizationThe COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.
Description: Severity assessment will be performed using the ordinal severity scale during hospitalization.
Measure: Severity assessment by ordinal severity scale Time: 3 days, 7 days, 14 days, 28 days after randomizationDescription: Severity assessment will be performed using the SOFA score during hospitalization.
Measure: Severity assessment by SOFA score Time: 3 days, 7 days, 14 days, 28 days after randomizationA randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.
Description: The number of participants with "Clinical improvement" determined by the improvement of individual presenting symptoms of the COVID19; changes in radiological and laboratory values.Patient admitted in general bed requiring High Dependency Unit (HDU), and an HDU patient requiring Ventilator or Intensive care support.
Measure: Clinical improvement Time: Following randomization 30 days.Description: Oxygen saturation in the peripheral blood determined by pulse oximetry.
Measure: Changes in Oxygen level Time: Following randomization 30 days.SARS-CoV-2 infection seems to induce in most critical cases an excessive and aberrant hyper-inflammatory host immune response that is associated with a so-called "cytokine storm", moreover pro-thrombotic derangements of haemostatic system is another common finding in most severe forms of COVID19 infections, which may be explained by the activation of coagulative cascade primed by inflammatory stimuli, in line with what is observed in many other forms of sepsis. Targeting inflammatory responses exploiting steroids' anti-inflammatory activity along with thrombosis prevention may be a promising therapeutic option to improve patients' outcome. Despite the biological plausibility, no good evidence is available on the efficacy and safety of heparin on sepsis patients, and many issues have to be addressed, regarding the proper timing, dosages and administration schedules of anticoagulant drugs. The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin (UFH) or with steroids and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days. The study is designed as a multicenter, national, interventional, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned in a ratio 1:1:1 to one of the three treatment groups: LMWH group, LMWH+steroids or UFH+steroid group. A possible result showing the efficacy of the composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.
Description: All-cause mortality at day 28, defined as the comparison of proportions of patients death for any cause at day 28 from randomization.
Measure: All-cause mortality at day 28 Time: Day 28 from randomizationDescription: All-cause mortality at ICU discharge, defined as the comparison of proportions of patients death for any cause at ICU discharge.
Measure: All-cause mortality at ICU discharge Time: from randomization to ICU discharge, censored at day 30Description: All-cause mortality at Hospital discharge, defined as the comparison of proportions of patients death for any cause at hospital discharge
Measure: All-cause mortality at hospital discharge Time: from randomization to ICU discharge, censored at day 90Description: Occurrence of rescue administration of high-dose steroids or immune-modulatory drugs
Measure: Need of rescue administration of high-dose steroids or immune-modulatory drugs Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of new organ dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score ≥3 for the corresponding organ occurring after randomization.
Measure: New organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Grade of organ dysfunction during ICU stay, grade of dysfunction is measured with Sequential Organ Failure Assessment (SOFA) score daily from randomization to day 28 or ICU discharge.
Measure: Grade of organ dysfunction during ICU stay Time: From randomization to ICU discharge, censored at day 28Description: Total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered.
Measure: ICU free days at day 28 Time: From randomization to day 28Description: Occurrence of new infections including bacterial infections, fungal infections by Candida, Aspergillus, and viral reactivations including Adenovirus, Herpes Virus e Cytomegalovirus
Measure: Occurrence of new infections Time: from randomization to day 28Description: Total number of days that patient is alive and free of ventilation between randomisation and day 28. Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.
Measure: Ventilation free days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Total number of days that patient is alive and free of vasopressors between randomisation and day 28.
Measure: Vasopressors free-days at day 28 Time: From randomization to day 28, censored at hospital dischargeDescription: Occurrence of switch from non-invasive to invasive mechanical ventilation
Measure: Switch from non-invasive to invasive mechanical ventilation Time: from randomization to ICU discharge, censored at day 28Description: Total number of hours from start of non-invasive to invasive ventilation to switch to invasive ventilation
Measure: Delay from start of non-invasive ventilation to switch to invasive ventilation Time: from randomization to ICU discharge, censored at day 28Description: Adverse events occurred from randomization to day 28. Events that are part of the natural history of the primary disease process or expected complications of critical illness will not be reported as adverse events.
Measure: Occurrence of protocol related adverse events Time: From randomization to day 28Description: Occurrence of objectively confirmed venous thromboembolism, stroke or myocardial infarction
Measure: Occurrence of venous thromboembolism, stroke or myocardial infarction Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of major bleeding defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death)
Measure: Occurrence of major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Occurrence of clinically relevant non-major bleeding defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm2, or 100 cm2, intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.
Measure: Occurrence of clinically relevant non-major bleeding (safety end point) Time: from randomization to ICU discharge, censored at day 28Description: Mean arterial pressure will be measured in millimeters of mercury
Measure: Mean arterial pressure Time: Daily from inclusion until ICU discharge, censored day 28Description: hearth rate will be measured in beats per minute
Measure: hearth rate Time: Daily from inclusion until ICU discharge, censored day 28Description: respiratory rate will be measured in breaths per minute
Measure: respiratory rate Time: Daily from inclusion until ICU discharge, censored day 28Description: diuresis will be measured daily in milliliters of urine output in the previous 24 hours
Measure: diuresis Time: Daily from inclusion until ICU discharge, censored day 28Description: systemic body temperature will be measured in celsius degrees
Measure: systemic body temperature Time: Daily from inclusion until ICU discharge, censored day 28Description: fluid balance will be measured in milliliters of fluids input and output in the previous 24 hours
Measure: fluid balance Time: Daily from inclusion until ICU discharge, censored day 28Description: Haemoglobin will be measured in mg/dl
Measure: Haemoglobin concentration Time: Daily from inclusion to ICU discharge (censored at day 28)Description: platelets count will be measured in U 10^3/mm^3
Measure: platelets count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: white blood cells count will be measured in U per 10^9/L
Measure: white blood cells count Time: Daily from inclusion to ICU discharge (censored at day 28)Description: troponin will be measured in µg/L
Measure: troponin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: coagulative function will be measured with parameters INR, PT, aPTT
Measure: coagulative function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: D-dimer will be measured in µg/ml
Measure: D-dimer Time: Daily from inclusion to ICU discharge (censored at day 28)Description: anti-thrombin will be measured as a percentage
Measure: anti-thrombin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: liver function will be assessed through measurement of AST, ALT in U/L
Measure: Liver function Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Bilirubin will be measured in mg/dL
Measure: Bilirubin Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Creatinine will be measured in mg/dL
Measure: Creatinine Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Blood cells count will be measured in Units per x 10^9/L of blood
Measure: Blood cells count Time: daily from inclusion to ICU discharge (censored at day 28)Description: C-reactive protein (CRP) will be measured in mg/dl
Measure: C-reactive protein (CRP) Time: daily from inclusion to ICU discharge (censored at day 28)Description: procalcitonin(PCT) wiull be measured in ng/ml
Measure: procalcitonin(PCT) Time: daily from inclusion to ICU discharge (censored at day 28)Description: interleukin 6 (IL-6) will be measured in pg/ml
Measure: interleukin 6 (IL-6) Time: daily from inclusion to ICU discharge (censored at day 28)Description: Ventilation mode will be cathegorized in spontaneous breathing, invasive or non invasive ventilation
Measure: Ventilation mode Time: Daily from inclusion to ICU discharge (censored at day 28)Description: inspired oxygen fraction will be measured in percentage of oxygen in inspired air
Measure: inspired oxygen fraction Time: Daily from inclusion to ICU discharge (censored at day 28)Description: Gas exchanges will be assessed by measurement of PaO2, PaCO2 in mmHg by arterial blood gas analysis
Measure: Gas exchanges Time: Daily from inclusion to ICU discharge (censored at day 28)Description: lactates will be measured in mMol/L
Measure: lactates Time: Daily from inclusion to ICU discharge (censored at day 28)Description: pH will be measured in pH scale
Measure: pH Time: Daily from inclusion to ICU discharge (censored at day 28)Description: oxygen saturation in blood will be measured in arterial and venous samples in percentage values
Measure: oxygen saturation in blood Time: Daily from inclusion to ICU discharge (censored at day 28)Description: New blood, respiratory and urinary-tract infections will be recorded
Measure: New infections Time: From randomization to day 28Description: Viral reactivation measured by CMV DNA titres will be recorded.
Measure: Viral reactivation Time: From randomization to day 28Description: Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) will be recorded.
Measure: Need of new renal replacement therapy Time: from randomization to day 28Description: Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded
Measure: Adjunctive treatments Time: from randomization to ICU discharge (censored at day 28);Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports