Name (Synonyms) | Correlation | |
---|---|---|
drug1131 | Hydroxychloroquine, Doxycycline Wiki | 0.30 |
drug2438 | Tacrolimus Wiki | 0.30 |
drug782 | Docetaxel Wiki | 0.30 |
drug1223 | Interferon-Alpha2B Wiki | 0.30 |
drug1130 | Hydroxychloroquine, Clindamycin, Primaquine - low dose. Wiki | 0.30 |
drug1127 | Hydroxychloroquine, Azithromycin Wiki | 0.30 |
drug330 | Berzosertib Wiki | 0.30 |
drug656 | Convalescent Serum Wiki | 0.30 |
drug1129 | Hydroxychloroquine, Clindamycin, Primaquine - high dose. Wiki | 0.30 |
drug1319 | Laboratory Biomarker Analysis Wiki | 0.30 |
drug1128 | Hydroxychloroquine, Clindamycin Wiki | 0.30 |
drug522 | Carboplatin Wiki | 0.21 |
drug2256 | Siltuximab Wiki | 0.21 |
drug3005 | standard care Wiki | 0.17 |
drug2612 | Usual Care Wiki | 0.13 |
drug2527 | Tocilizumab Wiki | 0.11 |
drug1598 | Nitazoxanide Wiki | 0.11 |
drug1374 | Losartan Wiki | 0.11 |
drug2067 | Remdesivir Wiki | 0.08 |
drug1822 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
D011471 | Prostatic Neoplasms NIH | 0.17 |
D002277 | Carcinoma NIH | 0.13 |
D011014 | Pneumonia NIH | 0.13 |
D018450 | Disease Progression NIH | 0.08 |
D014947 | Wounds and Injuries NIH | 0.07 |
D055370 | Lung Injury NIH | 0.06 |
D011024 | Pneumonia, Viral NIH | 0.04 |
D013577 | Syndrome NIH | 0.03 |
D012128 | Respiratory Distress Syndrome, Adult NIH | 0.03 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.02 |
D018352 | Coronavirus Infections NIH | 0.01 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0012125 | Prostate cancer HPO | 0.17 |
HP:0030731 | Carcinoma HPO | 0.13 |
HP:0002090 | Pneumonia HPO | 0.13 |
There are 11 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 randomization