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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1783 | Hydroxychloroquine + lopinavir/ritonavir Wiki | 0.33 |
| drug1541 | Five-days oseltamivir Wiki | 0.33 |
| drug1367 | Emapalumab Wiki | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2271 | Macrolide administered for 3-5 days Wiki | 0.33 |
| drug1544 | Fixed-duration Hydrocortisone Wiki | 0.33 |
| drug4746 | standard concomitant therapy Wiki | 0.33 |
| drug3952 | Ten-days oseltamivir Wiki | 0.33 |
| drug2390 | Mindfulness based intervention Wiki | 0.33 |
| drug3056 | Prasugrel Wiki | 0.33 |
| drug3125 | Protocolised mechanical ventilation strategy Wiki | 0.33 |
| drug271 | Amoxicillin-clavulanate Wiki | 0.33 |
| drug1968 | Interferon-β1a Wiki | 0.33 |
| drug4302 | Wharton's jelly derived Mesenchymal stem cells. Wiki | 0.33 |
| drug861 | Ceftaroline Wiki | 0.33 |
| drug4318 | XCEL-UMC-BETA Wiki | 0.33 |
| drug4015 | Ticagrelor Wiki | 0.33 |
| drug2913 | Piperacillin-tazobactam Wiki | 0.33 |
| drug2272 | Macrolide administered for up to 14 days Wiki | 0.33 |
| drug2440 | Moxifloxacin or Levofloxacin Wiki | 0.33 |
| drug3615 | Shock-dependent hydrocortisone Wiki | 0.33 |
| drug862 | Ceftriaxone Wiki | 0.33 |
| drug1545 | Fixed-duration higher dose Hydrocortisone Wiki | 0.33 |
| drug1824 | Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Wiki | 0.33 |
| drug1415 | Eritoran Wiki | 0.33 |
| drug12 | 0.9% Saline Wiki | 0.24 |
| drug2461 | N-Acetyl cysteine Wiki | 0.24 |
| drug3628 | Simvastatin Wiki | 0.24 |
| drug3989 | Therapeutic anticoagulation Wiki | 0.24 |
| drug942 | Clopidogrel Wiki | 0.19 |
| drug3618 | Siltuximab Wiki | 0.19 |
| drug3740 | Standard of care (SOC) Wiki | 0.19 |
| drug340 | Apremilast Wiki | 0.19 |
| drug1508 | Famotidine Wiki | 0.17 |
| drug356 | Aspirin Wiki | 0.17 |
| drug4025 | Tocilizumab Wiki | 0.16 |
| drug3532 | Sarilumab Wiki | 0.15 |
| drug2620 | Normal saline Wiki | 0.14 |
| drug4168 | Usual Care Wiki | 0.11 |
| drug2174 | Lopinavir/ritonavir Wiki | 0.11 |
| drug4249 | Vitamin C Wiki | 0.09 |
| drug1060 | Convalescent plasma Wiki | 0.07 |
| drug1511 | Favipiravir Wiki | 0.07 |
| drug1775 | Hydroxychloroquine Wiki | 0.03 |
| drug2916 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D016393 | Lymphoma, B-Cell NIH | 0.33 |
| D055501 | Macrophage Activation Syndrome NIH | 0.33 |
| D000163 | Acquired Immunodeficiency Syndrome NIH | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D008223 | Lymphoma, NIH | 0.14 |
| D015658 | HIV Infections NIH | 0.08 |
| D007239 | Infection NIH | 0.08 |
| D003141 | Communicable Diseases NIH | 0.07 |
| D014777 | Virus Diseases NIH | 0.07 |
| D013577 | Syndrome NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
| D055371 | Acute Lung Injury NIH | 0.06 |
| D012141 | Respiratory Tract Infections NIH | 0.05 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.05 |
| D011014 | Pneumonia NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012191 | B-cell lymphoma HPO | 0.33 |
| HP:0002665 | Lymphoma HPO | 0.14 |
| HP:0011947 | Respiratory tract infection HPO | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002090 | Pneumonia HPO | 0.02 |
Navigate: Correlations HPO
There are 9 clinical trials
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome of patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.
Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measure: Days alive and not receiving organ support in ICU Time: Day 21Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measure: Health-related Quality of life assessment Time: 6 monthsDescription: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measure: Destination at time of hospital discharge Time: Free text Day 90Description: Antibiotic Domain specific outcome
Measure: Occurrence of multi-resistant organism colonisation/infection Time: Day 90, censored at hospital dischargeDescription: Antibiotic Domain specific outcome
Measure: Occurrence clostridium difficile Time: Day 90, censored at hospital dischargeDescription: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time: Day 90, censored at hospital dischargeDescription: Antiviral Domain specific outcome. Only required at selected sites.
Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time: Day 3, up to Day 7Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint
Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) Time: Day 90, censored at hospital dischargeThis study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
Description: Determine the rate of severe neurotoxicities, >/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells
Measure: Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities Time: 4 weeksDescription: proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment.
Measure: Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation Time: 28 days from the start of treatmentAs shown by the data available, hyper-inflammation, caused by a cytokine storm resulting from an exaggerated response of the immune system to the presence of the virus, is considered to represent one of the most important negative prognostic factor in patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The objective of this study is to investigate new possibilities to reduce the number of patients requiring mechanical ventilation. This is intended to address the most urgent need to preserve the access to intensive care unit support to the lowest possible number of patients and may potentially reduce mortality.
Description: Defined as the proportion of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO)
Measure: Treatment success Time: Up to Day 15Description: Measured in days
Measure: Time to mechanical ventilation Time: Date of randomization to date of mechanical ventilationDescription: Measured in total score
Measure: Change from baseline in Modified Early Warning system score Time: Baseline, Day 15Description: Measured in percent (%)
Measure: Change from baseline in resting peripheral capillary oxygen saturation (SpO2) Time: Baseline, 3 assessments every Days 4, 7, 10, 13 and 15Description: Measured in percent (%)
Measure: Change from baseline in partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) Time: Baseline, Day 15Description: Measured in local units
Measure: Change of pH in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of carbon dioxide tension (pCO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of oxygen tension (pO2) in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of potassium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of sodium in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of chloride in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of lactic acid in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change of hemoglobin in hemogasanalysis from baseline Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in l/min
Measure: Change from baseline in oxygen supplementation Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in scan evaluation: Normal, Abnormal but not clinically significant, Abnormal clinical significant, Not Done
Measure: Change of findings of high-resolution computed tomography (CT) scan of the chest Time: Screening, Day 15Description: Measured in local units
Measure: Change from baseline in Ferritin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in lactate dehydrogenase (LDH) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in D-dimers Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in White Blood Cells with differential counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Red Blood Counts Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Hemoglobin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Platelet count Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Fibrinogen Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Complement factors C3/C4 Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Prothrombin time Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Cardiac troponin Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in aspartate aminotransferase (AST) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in alanine aminotransferase (ALT) Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in total bilirubin levels Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in C-Reactive Protein Time: Baseline, Days 4, 7, 10, 13 and 15Description: Measured in local units
Measure: Change from baseline in Creatinine Time: Baseline, Days 4, 7, 10, 13 and 15Description: Confirmation of death
Measure: Overall survival Time: Weeks 6 and 10Description: Measured in days
Measure: Time to hospital discharge Time: Weeks 6 and 10The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
Description: defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the hospital: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Time to Clinical Improvement Time: at day 15Description: defined as independece from supplemental oxygen
Measure: Time to improvement in oxygenation Time: during hospital admission (up to 28 days)Description: defined by Pa02/FiO2 ratio while breading room air
Measure: Mean change in oxygenation Time: day 1, day 15 or hospital discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7 Time: Day 1, day 7or hospital discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1 Time: at day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6 Time: at day 15 or hospital discharge, whichever is firstDescription: defined by Hs (Hemophagocytic Syndrome) score
Measure: incidence of secondary haemophagocytic lymphohistiocytosis Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1 Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6 Time: during hospital admission (up to 28 days)Our aim is to conduct one trial of personalized immunotherapy in patients with SARS-CoV-2 (COVID-19) associated with organ dysfunction and with laboratory findings of macrophage activation syndrome or immune dysregulation. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to immunotherapy treatment according to their needs.
Description: At least 25% decrease between baseline sequential organ failure assessment SOFA score and measured sequential organ failure assessment SOFA score at Study Day 8
Measure: Change of baseline total sequential organ failure assessment (SOFA) score Time: Visit study day 8Description: Resolution of all criteria of lower respiratory tract involvemed that led to study inclusion (except findings from imaging studies) at Study Day 8
Measure: Improvement of lung involvement measurements Time: Visit study day 8Description: At least 50% increase of pO2/FiO2 ratio between baseline and study visit Day 8
Measure: Increase of pO2/FiO2 ratio Time: Visit Study Day 8Description: Change of total sequential organ failure assessment (SOFA) score between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Comparison of change of baseline total sequential organ failure assessment (SOFA) score in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of lung involvement measurements between baseline and study visit day 8 will be compared with historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of change of lung involvement measurements in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Comparison of increase in pO2/FiO2 ratio towards historical comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of pO2/FiO2 ratio in enrolled subjects towards historical comparators Time: Screening, Day 8Description: Change of Sequential organ failure assessment (SOFA) score on day 28 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of sequential organ failure assessment (SOFA) score Time: Day 28Description: Mortality on day 28
Measure: Rate of Mortality Time: Day 28Description: Mortality on day 90
Measure: Rate of Mortality Time: Day 90Description: Cytokine stimulation from peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Cytokine stimulation Time: Screening, Day 4Description: Gene expression of peripheral blood mononuclear cells will be compared between days 0 and 4
Measure: Gene expression Time: Screening, Day 4Description: Change of serum/plasma proteins between days 0 and 4
Measure: Serum/plasma proteins Time: Screening, Day 4Description: Classification of immune function of screened patients who are not enrolled in study drug since they are not characterized with MAS or immune dysregulation
Measure: Classification of the immune function Time: ScreeningThe overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.
Description: Survival without needs of ventilator utilization (including non invasive ventilation and high flow) at day 14. Thus, events considered are needing ventilator utilization (including Non Invasive Ventilation, NIV or high flow), or death. New DNR order (if given after the inclusion of the patient) will be considered as an event at the date of the DNR.
Measure: Survival without needs of ventilator utilization at day 14 Time: 14 daysDescription: Proportion of patients alive without non-invasive ventilation of high low at day 4 (WHO progression scale ≤ 5). A patient with new DNR order at day 4 will be considered as with a score > 5.
Measure: WHO progression scale ≤ 5 Time: 4 daysDescription: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) at day 14 if patients have been intubated before day 14 ; or removal of NIV or high flow (for > 48h) if they were included under oxygen by NIV or High flow (score 6) and remained without intubation. Death or new DNR order (if given after the inclusion of the patient) will be considered as a competing event.
Measure: Cumulative incidence of successful tracheal extubation (defined as duration extubation > 48h) or withdrawal of NIV or high flow (for > 48h), at day 14 Time: 14 daysDescription: Proportion of patients with a decrease of WHO score of at least 1 point at day 4
Measure: Decrease of at least one point in WHO progression scale score Time: 4 daysDescription: WHO progression scale: Uninfected; non viral RNA detected: 0 Asymptomatic; viral RNA detected: 1 Symptomatic; Independent: 2 Symptomatic; Assistance needed: 3 Hospitalized; No oxygen therapy: 4 Hospitalized; oxygen by mask or nasal prongs: 5 Hospitalized; oxygen by NIV or High flow: 6 Intubation and Mechanical ventilation, pO2/FIO2>=150 OR SpO2/FIO2>=200: 7 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) OR vasopressors (norepinephrine >0.3 microg/kg/min): 8 Mechanical ventilation, pO2/FIO2<150 AND vasopressors (norepinephrine >0.3 microg/kg/min), OR Dialysis OR ECMO: 9 Dead: 10.
Measure: WHO progression scale Time: 7 and 14 daysDescription: Overall survival.
Measure: Survival Time: 14, 28 and 90 daysDescription: arterial blood pH of <7.25 with a partial pressure of arterial carbon dioxide [Paco2] of ≥60 mm Hg for >6 hours.
Measure: Respiratory acidosis Time: 4 daysDescription: Evolution of PaO2/FiO2 ratio.
Measure: PaO2/FiO2 ratio Time: day 1 to day 14Description: Time to oxygen supply independency.
Measure: Time to oxygen supply independency Time: 14 daysDescription: Duration of hospitalization.
Measure: Duration of hospitalization Time: 90 daysDescription: Time to negative viral excretion.
Measure: Time to negative viral excretion Time: 90 daysDescription: Time to ICU discharge.
Measure: Time to ICU discharge Time: 90 daysDescription: Time to hospital discharge.
Measure: Time to hospital discharge Time: 90 daysIn the SAVE study patients with lower respiratory tract infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at high risk for progression to serious respiratory failure will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in serious respiratory failure.
Description: The primary study endpoint is the ratio of patients who will develop serious respiratory failure SRF until day 14. Patients dying before study visit of day 14 are considered achieving the primary endpoint.
Measure: The ratio of patients who will develop serious respiratory failure (SRF) Time: Visit study day 14Description: Evaluation of clinical data (pO2/FiO2 and need of mechanical ventilation) between baseline and study visit day 14 will be compared with comparators from Hellenic Sepsis Study Group Database
Measure: Comparison of the rate of patients who will develop serious respiratory failure (SRF) until day 14 with comparators from Hellenic Sepsis Study Group Database receiving standard-of-care treatment Time: Visit study day 14Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 7
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of scoring for respiratory symptoms (evaluation of cough, chest pain, shortness of breath and sputum) in enrolled subjects between days 1 and 14
Measure: Change of scoring for respiratory symptoms in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 7 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of SOFA score in enrolled subjects between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of Sequential organ failure assessment (SOFA) score of enrolled subjects between days 1 and 14 (Sequential organ failure assessment range 0-24, high score associated with worst outcome)
Measure: Change of Sequential organ failure assessment (SOFA) score in enrolled subjects between days 1 and 14 Time: Visit study day 1, visit study day 14Description: Change of peripheral mononuclear blood cells' (PBMCs) functionality of enrolled subjects will be compared between days 1 and 7
Measure: Change of peripheral mononuclear blood cells' (PBMCs) functionality between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Change of plasma inflammatory mediators measured levels will be compared between days 1 and 7
Measure: Change of plasma inflammatory mediators levels between days 1 and 7 Time: Visit study day 1, visit study day 7Description: Mortality on day 30
Measure: Rate of Mortality Time: Visit study day 30Description: Mortality on day 90
Measure: Rate of Mortality Time: Visit study day 90Description: Transcriptional, proteomic and metabolomic change will be compared between days 1 and 7
Measure: Change of gene expression between days 1 nad 7 Time: days 1 and 7This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
Description: Percentage of subjects discharged from hospital without the need for intubation and mechanical ventilation
Measure: Percentage of patients discharged from the hospital alive and without the need for mechanical ventilation. Time: Variable up to Day 28Description: 25% change (decrease) in noted baseline elevations of serum ferritin, LDH, CRP, and d-dimer.
Measure: Percentage of subjects with 25% change (decrease) in cytokine storm markers at 48 hours Time: 48 hoursDescription: Supplemental oxygen requirement to maintain oxygen saturation >90% stable or decreased without escalation of respiratory support measures (addition of CPAP, initiation of mechanical ventilation)
Measure: Percentage of subjects without increase in oxygen requirement and no increase in oxygen delivery/respiratory support measures after 48 hours. Time: Day 2 (48 hours)-Day 10 (240 hours)Description: Time from initial dosing of IP to achievement of ≥93% oxygen saturation on room air for 24 hours
Measure: Average time in days to achieve sustained ≥93% oxygen saturation without oxygen/respiratory support Time: 0-10 daysDescription: Normalization or ≥ 75% improvement by Day 10 (120 hours) in each of the following laboratory CSS attributes elevated beyond the normal range at randomization: ferritin, fibrinogen, AST, ALT, leucopenia, thrombocytopenia, d-dimer, CRP, triglycerides, sCD25.
Measure: Percentage of subjects with resolution of laboratory markers of Cytokine Storm syndrome Time: Day 10Description: No increased prevalence of bacterial or fungal or viral infection through the time of hospital discharge until Day 28.
Measure: Percentage of subjects who develop bacterial or fungal or non-Covid-19 viral infection Time: Day 0-28Description: No failure to develop neutralizing antibody to Covid-19 measured at Day 28.
Measure: Percentage of subjects who develop neutralizing antibody to Covid-19 Time: Day 28The clinical syndrome associated with infection of the Coronavirus Disease 2019 (COVID-19) is notable for its variable clinical expression. Infection and transmission of the virus by asymptomatic individuals have been noted and represent one end of the clinical spectrum, while multi-organ failure, particularly pulmonary failure, and death represent the most severe end of the clinical spectrum. In a recent study published from the investigator's institution about the first 393 patients with COVID-19, 77.1% had a fever, a mechanism driven by IL-1. This suggests that there may be an excess release of IL-1 present. Cytokine storm syndrome (CSS) has been observed in patients with COVID-19 and has been proposed to contribute to the acute pulmonary failure that occurs. In distinct clinical settings, macrophage activation syndrome, elevated levels of pro-inflammatory cytokines, including IL-1, IL-6, and others, as well as elevations in laboratory indicators, including ferritin, CRP, d-dimer, and lymphopenia, have been observed. IL-1 production is induced in response to inflammatory stimuli and mediates various physiologic responses including inflammatory and immunological responses. Anakinra, a recombinant IL-1 receptor antagonist, has shown promise in treating CSS. It inhibits both IL-1-alpha and IL-1-beta. It is an FDA approved medication used in rheumatoid arthritis (RA) and Cryopyrin-Associated Periodic Syndromes (CAPS). Anakinra's ability to inhibit both IL-1 subtypes and short half-life makes it favorable to some experts. In the investigator's case-series, using anakinra in patients with COVID-19 showed promising in preventing the need for mechanical ventilation, and mortality subsequently. This study will determine the efficacy of anakinra, an interleukin (IL) -1 receptor blocker, in reducing the need for mechanical ventilation and/or 28-day mortality among patients with COVID-19 who have features of CSS and severe respiratory failure. The investigators will test the hypothesis that the proportion of subjects with COVID-19, features of CSS, and severe respiratory failure (World Health Organization (WHO) category 4 or 5) alive and without having required mechanical ventilation at day 28 from randomization will be 33% higher among those that receive anakinra compared to those that receive a placebo. A secondary hypothesis is that the number of subjects alive at 60-days will be higher amongst those who receive anakinra compared to those who receive a placebo.
Description: This will be measured among subjects with COVID-19, features of CSS, and severe respiratory failure (WHO category 4 or 5) who are alive and without having required mechanical ventilation 28 days post randomization.
Measure: Number of subjects alive without having required mechanical ventilation Time: 28 days post randomizationDescription: Mortality of participants will be compared between those that received anakinra and those that did not.
Measure: 60-day mortality Time: 60 days post randomizationDescription: The number of days of hospitalization in the anakinra group compared to placebo after randomization up to day 28.
Measure: Patient Hospitalization Time: 28 days post randomizationDescription: The number of days with supplemental oxygen, with noninvasive ventilation or high-flow oxygen at day 28 after randomization in the anakinra group compared to placebo.
Measure: Patient Mechanical Ventilation Time: 28 days post randomizationAlphabetical 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