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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3487 | SOC + Intravenous Famotidine Wiki | 0.71 |
| drug2868 | Peripheral blood draw Wiki | 0.50 |
| drug3488 | SOC + Placebo Wiki | 0.50 |
Navigate: Correlations HPO
There are 2 clinical trials
The exceedingly high mortality rates of severe and critical COVID-19 warrant the identification and evaluation of novel therapies that could potentially mitigate the advanced disease manifestations. Based on preclinical data from this institution and others, the investigators hypothesize that PI3K inhibition with duvelisib could potentially quell aberrant hyperactivtation of the innate immune system, preferentially polarize macrophages, reduce pulmonary inflammation, and limit viral persistence, thereby improving patient outcomes.
Description: -For those on a ventilator at the time of randomization
Measure: Duration of ventilator use Time: Through completion of follow-up (estimated to be 7 months)Description: -Defined as increase in viral load of >0.5 log on two consecutive days, or >1 log increase in one day, not in keeping with any baseline trend of rising viral loads during the pre-treatment viral testing
Measure: Viral kinetics as measured by virologic failure Time: Through completion of follow-up (estimated to be 7 months)In this study, a total of 80 patients with severe coronavirus disease 2019 (COVID-19) infection will be randomized to receive Duvelisib or a placebo. Participants will be enrolled at Emory University Hospital and at the University of Pennsylvania and will be identified and recruited by their treating physician and research team.
Description: This is a composite endpoint of the number of participants who require mechanical ventilation or who die within four weeks of randomization.
Measure: Number of Participants Requiring Mechanical Ventilation or Dying Time: Up to Day 29Description: Time to recovery (in days) is defined as a score of greater than 5 from the following eight categories from the NIAID ordinal scale. The scale is as follows: 1. Death; 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized, limitation on activities and/or requiring home oxygen; 8. Not hospitalized, no limitations on activities.
Measure: Days to Recovery Time: Up to Day 29Description: The number of days spent hospitalized will be compared between study arms.
Measure: Duration of Hospitalization Time: Up to Day 29Description: The incidence of death within 29 days of randomization will be compared between study arms.
Measure: Incidence of Death Time: Up to Day 29Description: Comparing the proportion of subjects in each group requiring ICU transfer within 29 days of randomization
Measure: Proportion of Participants Transferred to ICU Time: Up to Day 29Description: The ECOG Performance Status instrument includes a single item assessing overall physical status. Health status is rated on a scale of 0 to 5 where 0 = fully active and 5 = dead. Median ECOG performance will be compared between study arms.
Measure: Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score Time: Day 15, Day 29Description: The incidence of grade III-V adverse events or Serious Adverse Events (SAEs), as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5, will be compared between study arms.
Measure: Incidence of Grade III-V Adverse Events Time: Up to Day 29Description: The incidence of documented secondary bacterial or viral infections among participants will be compared between study arms.
Measure: Incidence of Secondary Bacterial or Viral Infections Time: Up to Day 29Description: The mean frequency of Th1 T cells in blood mononuclear cells will be compared between study arms.
Measure: Change in Th1 T Cell Frequency Time: Weeks 1, 2, and 4Description: The mean frequency of Th17 T cells in blood mononuclear cells will be compared between study arms.
Measure: Change in Th17 T Cell Frequency Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-2 will be compared between study arms.
Measure: Change in Interleukin-2 (IL-2) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-2R will be compared between study arms.
Measure: Change in Interleukin-2 receptor (IL-2R) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-6 will be compared between study arms.
Measure: Change in Interleukin-6 (IL-6) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-7 will be compared between study arms.
Measure: Change in Interleukin-7 (IL-7) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-8 will be compared between study arms.
Measure: Change in Interleukin-8 (IL-8) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IL-10 will be compared between study arms.
Measure: Change in Interleukin-10 (IL-10) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker IP-10 will be compared between study arms.
Measure: Change in Interferon gamma-induced Protein 10 (IP-10) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker MIP-1a will be compared between study arms.
Measure: Change in Macrophage Inflammatory Protein 1alpha (MIP-1a) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker MCP-1 will be compared between study arms.
Measure: Change in Monocyte Chemoattractant Protein-1 (MCP-1) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker G-CSF will be compared between study arms.
Measure: Change in Granulocyte Colony-stimulating Factor (G-CSF) Time: Weeks 1, 2, and 4Description: Mean levels of the inflammatory serum biomarker TNF-alpha will be compared between study arms.
Measure: Change in Tumor Necrosis Factor (TNF)-alpha Time: Weeks 1, 2, and 4Description: VIP is a peptide hormone with immunosuppressive properties. Mean levels VIP will be compared between study arms.
Measure: Change in Vasoactive Intestinal Peptide (VIP) Time: Weeks 1, 2, and 4Description: Mean levels of the Tregs will be compared between study arms.
Measure: Change in Gene Expression Profile of Regulatory T Cells (Tregs) Time: Weeks 1, 2, and 4Description: Mean levels of CD8+IFNg+GM-CSF+ will be compared between study arms.
Measure: Change in Gene Expression Profile of cluster of differentiation 8 (CD8)+Interferon Gamma (IFNg)+ Granulocyte-macrophage colony-stimulating factor (GM-CSF)+ Time: Weeks 1, 2, and 4Description: Mean levels of CD8+Tim3+PD-1+ will be compared between study arms.
Measure: Change in Gene Expression Profile of CD8+ T cell immunoglobulin and mucin domain-containing protein 3 (Tim3)+ Programmed cell death protein 1 (PD-1)+ Time: Weeks 1, 2, and 4Description: Mean levels of CD14+CD16+ monocytes will be compared between study arms.
Measure: Change in Gene Expression Profile of cluster of differentiation 14 (CD14)+ cluster of differentiation (CD16)+ monocytes Time: Weeks 1, 2, and 4Description: Mean levels of SARS-CoV-2 viremia in respiratory specimens will be compared between study arms.
Measure: Change in SARS-CoV-2 Viremia Time: Weeks 1, 2, and 4Description: Median titers of IgG antibodies to SARS-CoV-2 will be compared between study arms.
Measure: Change in Immunoglobulin G (IgG) Antibodies Time: Weeks 1, 2, and 4Description: Median titers of IgM antibodies to SARS-CoV-2 will be compared between study arms.
Measure: Change in Immunoglobulin M (IgM) Antibodies Time: Weeks 1, 2, and 4Description: Overall survival is defined as days from randomization to death and censored at last follow up.
Measure: Overall Survival Time: Up to Day 29Alphabetical 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