Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to assess the safety and efficacy of orally administered NLRP3 inhibitor, dapansutrile, for the treatment of moderate COVID-19 symptoms and early cytokine release syndrome (CRS) in an ambulatory, at-home setting. Coronavirus disease 2019 (COVID-19) is caused by infection from a new strain of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 is characterized by fever, cough and shortness of breath, which in certain patients can lead to systemic organ failure and mortality. The data show that SARS-CoV-2 activates the innate immune signaling sensor NLRP3. Activation of NLRP3 initiates the cytokine release syndrome (CRS), which includes the production of primary cytokine, IL-1, triggering an intense inflammatory response that is prevalent in symptomatic COVID-19 patients. When CRS advances further to a fulminant 'cytokine storm', the data show that respiratory distress syndrome and multiple-organ failure take place. As a specific inhibitor of NLRP3, dapansutrile may reduce or prevent the hyperinflammation associated with CRS by inhibiting the production of IL-1β early to arrest the progression to a severe 'cytokine storm.' The end result would be a reduction in the need for COVID-19 patients to receive intensive medical treatment, allowing for fewer hospitalizations, administration of mechanical ventilation and deaths.
Description: Proportion of subjects with complete resolution of fever symptoms (feeling feverish, chills, shivering and/or sweating) and shortness of breath by Day 15
Measure: Proportion of subjects with complete resolution of fever symptoms and shortness of breath Time: Day 15Description: Evaluate the cumulative incidence of SAEs of dapansutrile relative to placebo
Measure: Cumulative incidence of SAEs Time: Day 45Description: Evaluate the cumulative incidence of Grade 3 and Grade 4 Adverse Events of dapansutrile relative to placebo
Measure: Cumulative incidence of Grade 3 and Grade 4 Adverse Events Time: Day 45Description: Evaluate the cumulative incidence of discontinuation or temporary suspension (for any reason) of dapansutrile relative to placebo
Measure: Discontinuation or temporary suspension of participation Time: Day 45Description: Evaluate changes in white cell count of dapansutrile relative to placebo over time
Measure: Changes in white cell count Time: Day 8, Day 15Description: Evaluate changes in hemoglobin of dapansutrile relative to placebo over time
Measure: Changes in hemoglobin Time: Day 8, Day 15Description: Evaluate changes in platelets of dapansutrile relative to placebo over time
Measure: Changes in platelets Time: Day 8, Day 15Description: Evaluate changes in creatinine of dapansutrile relative to placebo over time
Measure: Changes in creatinine Time: Day 8, Day 15Description: Evaluate changes in glucose of dapansutrile relative to placebo over time
Measure: Changes in glucose Time: Day 8, Day 15Description: Evaluate changes in total bilirubin of dapansutrile relative to placebo over time
Measure: Changes in total bilirubin Time: Day 8, Day 15Description: Evaluate changes in ALT of dapansutrile relative to placebo over time
Measure: Changes in ALT Time: Day 8, Day 15Description: Evaluate changes in AST of dapansutrile relative to placebo over time
Measure: Changes in AST Time: Day 8, Day 15Description: Evaluate changes in incidence of new infection that occurs during the study of dapansutrile relative to placebo
Measure: Incidence of new infection that occurs during the study Time: Day 8, Day 15Description: Evaluate changes in incidence of opportunistic infections of dapansutrile relative to placebo
Measure: Incidence of opportunistic infections Time: Day 8, Day 15Description: Proportion of subjects who experience clinical resolution of fever symptoms and shortness of breath
Measure: Complete resolution of fever symptoms and shortness of breath Time: Day 8, Day 29 and Day 45Description: Time to clinical improvement in fever symptoms and shortness of breath
Measure: Time to clinical improvement Time: Baseline/Day 1 to Day 15Description: Time to sustained absence of fever, defined as at least 2 days since last temperature measurement of ≥ 38˚C (100.4°F)
Measure: Time to sustained absence of fever Time: Baseline/Day 1 to Day 15Description: Proportion of subjects who experience clinical improvement in symptoms relevant to COVID 19 (e.g., cough, diarrhea, vomiting)
Measure: Clinical improvement in symptoms relevant to COVID 19 Time: Day 15Description: Incidence of subjects meeting the composite endpoint of subjects requiring hospitalization (hospitalization is defined as ≥ 24 hours of acute care), supplemental oxygen, mechanical ventilation, or who die
Measure: Incidence of composite endpoint of hospitalization, supplemental oxygen, mechanical ventilation, or death Time: Day 45Description: Proportion of subjects who experience clinical improvement in symptoms by Day 15, defined as a reduction of two or more points on the WHO Ordinal Scale for Clinical Improvement (lowest score between Baseline Visit/Day 1 and Day 15)
Measure: Clinical improvement in symptoms Time: Baseline/Day 1 to Day 15Description: Improvement in oxygenation over the course of the study and maintenance of this effect
Measure: Improvement in oxygenation Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in AST
Measure: Change in ALT Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in AST
Measure: Change in AST Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in blood glucose
Measure: Change in blood glucose Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Erythrocyte Sedimentation Rate (ESR)
Measure: Change in Erythrocyte Sedimentation Rate (ESR) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Hemoglobin A1c (HbA1C)
Measure: Change in Hemoglobin A1c (HbA1C) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Lactate dehydrogenase (LDH)
Measure: Change in Lactate dehydrogenase (LDH) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Lymphocyte, Absolute count
Measure: Change in Lymphocyte, Absolute count Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Monocyte, Absolute count
Measure: Change in Monocyte, Absolute count Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Neutrophils, Absolute count
Measure: Change in Neutrophils, Absolute count Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Eosinophil, Absolute count
Measure: Change in Eosinophil, Absolute count Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in CRP
Measure: Change in CRP Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in D-Dimer
Measure: Change in D-Dimer Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Ferritin
Measure: Change in Ferritin Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Fibrinogen
Measure: Change in Fibrinogen Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in Partial Thromboplastin Time (PTT) and International Normalized Ratio (INR)
Measure: Change in Partial Thromboplastin Time (PTT) and International Normalized Ratio (INR) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in IL-1β
Measure: Change in IL-1β Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in IL-6
Measure: Change in IL-6 Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in IL-18
Measure: Change in IL-18 Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in granulocyte colony-stimulating factor (G-CSF)
Measure: Change in granulocyte colony-stimulating factor (G-CSF) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in interferon-γ-induced protein 10 (IP-10)
Measure: Change in interferon-γ-induced protein 10 (IP-10) Time: Baseline/Day 1 to Day 15Description: Assess and compare change from Baseline in C3a
Measure: Change in C3a Time: Baseline/Day 1 to Day 15Alphabetical 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